View Future GrowthThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsBiodexa Pharmaceuticals 과거 순이익 실적과거 기준 점검 0/6Biodexa Pharmaceuticals은 연평균 9.8%의 비율로 수입이 증가해 온 반면, Biotechs 산업은 연평균 12.4%의 비율로 증가했습니다. 매출은 연평균 21.4%의 비율로 감소했습니다.핵심 정보9.79%순이익 성장률-14.27%주당순이익(EPS) 성장률Biotechs 산업 성장률-14.59%매출 성장률-21.38%자기자본이익률-242.13%순이익률-1,095.28%최근 순이익 업데이트31 Dec 2022최근 과거 실적 업데이트Reported Earnings • May 01Full year 2022 earnings released: UK£0.077 loss per share (vs UK£1.36 loss in FY 2021)Full year 2022 results: UK£0.077 loss per share. Revenue: UK£699.0k (up 21% from FY 2021). Net loss: UK£7.66m (loss widened 40% from FY 2021).공고 • Aug 28Midatech Pharma plc to Report First Half, 2020 Results on Sep 10, 2020Midatech Pharma plc announced that they will report first half, 2020 results on Sep 10, 2020모든 업데이트 보기Recent updates공고 • Oct 04Biodexa Pharmaceuticals PLC Provides Update on Progression Free and Overall Survival in Phase 1 Study of MTX110 in Recurrent GlioblastomaBiodexa Pharmaceuticals PLC announced an update in respect of its open label Phase 1 study of MTX110 in recurrent glioblastoma. In October 2023, the Company announced completed recruitment of four patients into cohort A of its Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in patients with recurrent glioblastoma (rGBM). MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. Patients received MTX110 via intermittent repeated CED infusions. As of today, the status of patients in Cohort A is as follows: Patients #1 and #2 have deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively. Patients #3 and #4 remain in post-study follow-up. Patient #3 had progression free survival (PFS) of six months and OS thus far of 13 months since start of treatment. Patient #4 has not yet had confirmed progression and, as of today, has PFS and OS of 12 months since start of treatment. Glioblastoma (GBM) is the most aggressive central nervous system (CNS) primary malignancy in adults with an annual incidence is approximately 3 per 100,000 population. The standard of care in newly diagnosed GBM includes maximal safe surgical resection, followed by concurrent radiotherapy and temozolomide (TMZ). GBM virtually always recurs with median PFS of 1.5–6.0 months and median OS of 2.0–9.0 months. These interim data in rGBM build on the data announced by the Company on July 2, 2024, and presented at the recent 21st International Symposium on Paediatric Neuro-Oncology (ISPNO 2024) of a Phase 1 study of MTX110 in nine patients with Diffuse Midline Glioma (“DMG”) which showed, after only two infusions and a single patient at optimum dose, median OS of 16.5 months. In an earlier Phase 1 study conducted by the University of California San Francisco of MTX110 in seven patients with DMG which showed median OS of 26.1 months. These data compare favorably with median OS in a cohort of 316 cases of 10.0 months (source: Jansen et al, 2015. Neuro-Oncology 17(1):160-166).공고 • Sep 16Biodexa Pharmaceuticals plc Announces to Made the Final Match Payment with Respect to A $17 Million Grant from the Cancer Prevention Research Institute of TexasBiodexa Pharmaceuticals PLC announced it made the final match payment of $3.0 million with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT). Familial Adenomatous Polyposis (FAP) is an inherited disease that causes the growth of hundreds or thousands of precancerous polyps throughout the GI tract, putting those afflicted at great risk of developing colon cancer. There is no approved therapeutic option for treating the approximately 100,000 FAP patients in the U.S. and Europe. The current standard of care is active surveillance and surgical resection of the colon and/or rectum. Results of a 12 month Phase 2 clinical trial of eRapa in FAP demonstrated a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. A Phase 3 registrational trial is expected to begin enrollment early next year.공고 • Aug 31Biodexa Pharmaceuticals Announces Receipt of Nasdaq Delisting Determination - Plans to AppealBiodexa Pharmaceuticals PLC announced that on August 27, 2024, it received a Staff Determination letter (the ‘Letter’) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market because the Company’s securities have had a closing bid price below $1.00 for 30 consecutive business days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5550(a)(2) (the ‘Rule’). Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Rule. However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, and as described in the Letter, unless the Company timely requests a hearing before a Hearings Panel (the ‘Panel’), the Company’s securities would be subject to suspension/delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing.공고 • Jul 25Biodexa Pharmaceuticals Plc has completed a Follow-on Equity Offering in the amount of $5.009969 million.Biodexa Pharmaceuticals Plc has completed a Follow-on Equity Offering in the amount of $5.009969 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 5,050,808 Price\Range: $0.94 Discount Per Security: $0.0752 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 278,975 Price\Range: $0.9399 Discount Per Security: $0.075192 Transaction Features: Registered Direct Offering공고 • Jul 12Biodexa Pharmaceuticals Plc Announces Additional Positive Results of Phase 2 Trial of eRapa in Treatment of Precancerous Polyps in the GI Tract - Now 12-Month DataBiodexa Pharmaceuticals PLC is making good progress with eRapa™, its drug to treat Familial Adenomatous Polyposis (FAP). FAP is a mostly inherited condition that puts people at a much greater risk of developing colorectal cancer. Positive 12-month data from a phase 2 clinical trial were recently presented at the 2024 InSIGHT biannual meeting in Barcelona. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients - for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon and/or rectum resected and having to carry a colostomy bag for the remainder of their lives. If left untreated, there is a 100% chance the person will develop colorectal cancer. A Better Way Of Treating FAP: While multiple screenings and surgeries are a way of life for the more than 100,000 people worldwide who suffer from this condition, it doesn't have to remain that way. Biodexa believes eRapa could be the first therapeutic option to treat this precancerous condition, and its data so far backs up that assessment. Results of a 12-month phase 2 clinical trial of eRapa demonstrated an overall 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Even more compelling, of patients in Cohort 2 (treated daily, alternate weeks), 89% of patients were deemed non-progressors at 12 months, with a median reduction in polyp burden of 29%. That could be gaming-changing for FAP patients if it means fewer surgeries with much improved quality of life. The 12-month data demonstrate a longevity of effect of eRapa. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. Too much mTOR has been linked to cancer. Stopping It In Its Tracks: The phase 2 open-label study of 30 adults with FAP was conducted in seven U.S. centers of excellence. The median age of the trial participants was 43 years, with either an intact colon or one with a portion removed and at least ten noncancerous tumors in the rectal remnant. Patients were enrolled in three dosing cohorts, including every other day, daily every other week and daily. Although the primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, patients continued to receive treatment and monitoring for 12 months, leading to the new data. Biodexa said the dosing given to cohort 2 - daily every other week - will likely be the preferred dosage regime for its phase 3 trial, which the company is gearing up to launch soon. That study is planned to be a double-blind placebo-controlled design recruiting approximately 140 high-risk patients diagnosed with germline or phenotypic FAP. Biodexa's phase 2 results were presented at InSIGHT by Carol Burke, M.D., a specialist gastroenterologist at the Cleveland Clinic and a leading authority in FAP. Burke is the Principal Investigator for both the phase 2 study and the upcoming phase 3 study. The phase 2 trial was partially supported by $3 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT). CPRIT is providing a $17 million grant for the phase 3 trial. FAP may be rare, but for the tens of thousands of people suffering from this precancerous condition, there's got to be a better treatment. Biodexa believes it has that with eRapa. The phase 2 trial results seem to lean that way, and with a phase 3 study about to kick off, there may be hope on the horizon for FAP patients.공고 • Jul 02Biodexa Pharmaceuticals PLC Announces Positive Phase 1 Clinical Data of MTX110 in DMG Brain Cancer Demonstrating Increased Survival Presented at ISPNO 2024Biodexa Pharmaceuticals PLC announced data from a Phase 1 study of MTX110 in Diffuse Midline Glioma (DMG) f/k/a Diffuse Intrinsic Pontine Glioma, or DIPG, an orphan pediatric brain cancer were presented over the weekend at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia, PA. Results of the Phase 1 study: Overall, the treatment was well tolerated by patients. There was one Grade 4 adverse event assessed by the investigators as unrelated to the drug but related to the infusion and tumor anatomy. Most other adverse events were related to infusion and were deemed Grade 2 to 3. Although the study was not powered to reliably demonstrate efficacy, median progression free survival (PFS) was 10 months (range 8 to 20 months) and overall survival (OS) of patients in the study was 16.5 months (range 12 to 35 months). This compares favorably with median OS in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Design of the Phase 1 study: The open label investigator-initiated study was conducted by Columbia University Irving Medical Center in patients newly diagnosed with DMG. Patients were administered MTX110 via convection enhanced delivery (“CED”) using a subcutaneous pump connected to a catheter directly implanted into the pons in a 3+3 dose-escalating design (NCT 04264143). As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary endpoint of the study was to evaluate the safety and maximum tolerated dose with secondary endpoints of Progression Free Survival and Overall Survival. The number of infusions was limited to two, each of 48 hours, seven days apart. Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2). Although the study was not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months. This compares favorably with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). MTX110 in DMG: In October 2020, the Company announced headline results from a Phase I study at the University of California, San Francisco (“UCSF”) in patients with DMG (the “UCSF study” NCT03566199). The primary endpoint of the study was to determine the dosage regimen to be used in a proposed Phase II study of the safety and efficacy of MTX110 in patients with DIPG. Preliminary high-level data from the UCSF study supports a dose of between 60µM and 90µM of MTX110, depending upon patient tolerance over the course of 12 infusions in Phase II. In total, seven patients were recruited into the UCSF study. Patients were newly diagnosed with DMG and received focal external beam radiation therapy four to 14 weeks before commencement of MTX110 treatment. MTX110 was administered directly into the tumour via a micro-catheter using CED with gadolinium-enhanced intra-operative MRI to guide and track drug distribution to the tumour. Patients could receive up to 12 cycles of treatment every four to eight weeks. The dose was escalated between and within patients as tolerated initially by increasing the infusion volume at a concentration of 30µM MTX110 and then with higher drug concentrations of 60µM and 90µM as the sixth and seventh dose increments, respectively. Median overall survival based on Kaplan Meier analysis was 26.06 months. Survival was not an endpoint of the UCSF study nor was the study powered for statistical significance.공고 • Jun 24Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ At 12 Months in Familial Adenomatous Polyposis (Fap)Biodexa Pharmaceuticals Plc announced that 12 month results of a Phase 2 clinical trial of eRapa™ in Familial Adenomatous Polyposis (NCT04230499) were reported in an oral presentation at the prestigious 2024 InSIGHT bi-annual meeting in Barcelona by Carol Burke, M.D., a specialist gastroenterologist at the Cleveland Clinic and a leading authority in FAP, a mostly genetic disease of precancerous polyps for which the only current remedy is surgical removal of the colon and/or rectum. The Phase 2 study was partially supported by $3 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) under product development awards DP22053 and DP190069. The Phase 3 study of eRapa in FAP is supported by a $17 million grant from CPRIT. Dr. Burke is the Principal Investigator for the both the Phase 2 study and the upcoming Phase 3 registrational study. The open-label study was conducted in seven U.S. centers of excellence in 30 adult patients with median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis and at least 10 adenomas in the rectal remanent (n=24). Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Although the primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, as measured by the aggregate of all polyp diameters, patients continued to receive treatment and monitoring for 12 months (secondary endpoint). Results of the Phase 2 study at 12 months Overall, 21 of 28 (75%) patients were deemed to be non-progressors at 12 months with a median reduction in polyp burden of 17%. In Cohort 2, eight of nine (89)% of patients were deemed non-progressors at 12 months with a median reduction in polyp burden of 9%. Over the course of 12 months, there were four related Grade 3 or higher and one related Serious Adverse Event reported during the trial and 95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance. The Phase 3 registrational study is planned to be a double-blind placebo-controlled design recruiting approximately 140 high risk patients diagnosed with germline or phenotypic FAP. The primary clinical endpoint is likely to be the first progression free survival event which will include major surgery (or referral thereto), polypectomy for advanced neoplasia, advancement of Spigelman stage, diagnosis of high-grade dysplasia or cancer and death from any cause. A $17 million grant from CPRIT will support this study. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035.공고 • Jun 05Biodexa Pharmaceuticals plc Announces Promising Phase 2 Results for Its Newly In-Liced Drug Erapa for Treating Fam Fam Famic Adenomatous PolyposisBiodexa Pharmaceuticals just announced promising phase 2 results for its newly in-licensed drug eRapa for treating familial adenomatous polyposis (FAP), a mainly genetic disease of the lower GI tract for which there is currently no remedy except surgical removal of the colon and/or rectum. In a clinical trial involving 30 adult patients, three groups received the same dose of the drug but with different regimens over a period of 12 months. Safety, tolerability and changes from baseline in polyp burden (measured by the sum of polyp diameters) were evaluated using endoscopic exams. After the first six months, eRapa appeared to be safe and well-tolerated with a statistically significant 24% reduction (p=0.04) in the total polyp burden compared with baseline, as well as an overall 83% non-progression rate. In other words, the drug has been proven to have a high success rate at stopping the growth of polyps before they get a chance to turn into cancer. Biodexa claims that no drug before has shown such promise in stalling the progression of this disease. The company plans to announce the 12-month results of the phase 2 trial at the InSIGHT scientific conference in Barcelona on June 19-22. FAP is an inherited disease affecting the gastrointestinal tract. If left untreated, it causes hundreds to thousands of polyps to grow inside the colon or rectum. The condition is typically diagnosed in the early teenage years and results in a nearly 100% lifetime risk of colorectal cancer. Treatment options are very limited, with the only current remedy for FAP being surgical removal of the colon and/or rectum, a surgery that always results in the lifelong use of a colostomy bag. With roughly 100,000 individuals in the United States and Europe affected by FAP, there is a considerable need for an effective non-surgical intervention. In April, Biodexa acquired worldwide exclusive rights to eRapa, a drug that the company hopes will delay or prevent the need for surgery. eRapa is a proprietary oral tablet formulation of rapamycin, which is known to play a role in regulating cellular metabolism, growth and proliferation - all crucial factors in cancer development. Using nanotechnology and pH-sensitive polymers, Biodexa has designed eRapa to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. The medication can also potentially be used to treat bladder and prostate cancers. Results of an ongoing phase 2 study into bladder cancer are expected to be announced in the second quarter of 2025. Crucially, the Cancer Prevention Research Institute of Texas (CPRIT) has awarded a $17 million grant to support the phase 3 registrational study of eRapa in FAP. The grant requires a 1 for 2 match and Biodexa recently announced that it secured $7 million, most of the required $8.5 million match, in financing through the exercise of existing warrants, which the company intends to use to advance eRapa through the final clinical stage. A phase 3 trial is expected to start in the first quarter of 2025 which, if successful, is expected to lead to applications for marketing approvals in the U.S. and Europe. eRapa has the potential to catapult Biodexa from a clinical-stage biotech to a commercial organization, supported by non-dilutive grant funding for a devastating disease that currently has no FDA-approved drugs. All eyes are now on the upcoming 12-month results of the phase 2 trial to be announced later this month, and the subsequent phase 3 trial next year.공고 • May 23Biodexa Pharmaceuticals PLC Announces Positive Statistically Significant Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis (FAP) Scheduled for Presentation at the 2024 Digestive Disease Week Annual MeetingBiodexa Pharmaceuticals PLC announced that results of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis (‘FAP’) (NCT04230499) are scheduled for presentation at the prestigious 2024 Digestive Disease Week annual meeting in Washington D.C. Carol Burke, MD, the Principal Investigator, will present the six month data in a podium presentation at the meeting. The study was partially supported by $20 million in grant funding from the Cancer Prevention and Research Institute of Texas under product development awards DP22053 and DP190069. Design of the Phase 2 study: The open-label study was conducted in seven U.S. centers of excellence in 30 adult patients with median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis and at least 10 adenomas in the rectal remanent (n=24). Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, as measured by the aggregate of all polyp diameters. Polyp outcomes were classified into Progressive Disease (PD: >20% increase in polyp burden), Stable Disease (SD: ± 20% change in polyp burden) or Partial Response (PR: >20% reduction in polyp burden). A combination endpoint of non-progressors included SD and PR. Results of the Phase 2 study at six months: In the duodenum, 14/18 (78%) patients were non-progressors with 11/18 (61%) of these patients with PR. In the colorectum, 25/29 (86%) patients were non progressors including all with an intact colon; of these 15/29 (67%) patients demonstrated PR including 4 with an intact colon. Only two drug-related Grade 3 Serious Adverse Events occurred during the trial (with no Grade 4 or 5 reported), and 97% of patients remained on treatment at six months.공고 • May 18Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 13, 2024Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 13, 2024. Location: 1 caspian point, caspian way, cardiff cf10 4dq, United Kingdom공고 • Mar 29Biodexa Pharmaceuticals Plc's MTX110 Shows Promise In Extending Life Expectancy Against Aggressive Brain CancersBiodexa Pharmaceuticals is developing MTX110 for the treatment of Diffuse Midline Glioma (DMG) in pediatric patients and for Recurrent Glioblastoma (rGBM) in adults; two aggressive brain cancers with universally poor prognoses. The company says early trials of MTX110 in both cancers show promise in extending survival rates beyond those reported in previously published studies. DMG tumors are highly aggressive grade IV tumors that exhibit a propensity to infiltrate the surrounding tissues. Commonly found throughout the brainstem, these tumors pose significant challenges in treatment. The median overall survival rate for individuals - typically children diagnosed with diffuse midline glioma is less than one year - generally ranges from eight to 11 months. A small percentage, approximately 10%, manage to survive for at least two years following diagnosis. Glioblastoma (GBM) is the most prevalent malignant primary tumor of the central nervous system in adult patients and is known for its aggressive nature and tendency to invade surrounding tissues. Although GBM is rare, it carries a high fatality rate, with an incidence of 3.44 per 100,000 individuals and a median overall survival of only eight months, regardless of treatment. The five-year survival rate stands at a mere 7.2%. Recurrence poses a significant challenge for adult patients with GBM, and the prognosis remains bleak. Tumor recurrence, typically occurring within seven months from the initial diagnosis, is the primary cause of mortality. Both cancers have a high mortality rate and a high unmet need. Biodexa is hoping to meet these needs as it further develops MTX110. The main chemotherapy agent of MTX110, panobinostat, was originally used to treat multiple myeloma and received FDA approval in 2015. The company is currently reworking the chemotherapy agent by changing its delivery method and leveraging Convection Enhanced Delivery (CED) technology. Researchers discovered that the original formulation of panobinostat was capable of blocking enzymes involved in cancer cell growth, exhibiting high potency against brain stem tumor cells in vitro and in vivo. However, the original oral tablet form is both insoluble and incapable of crossing the blood-brain barrier at therapeutic levels - making it an ineffective treatment method for brain cancers. The distinctive feature of MTX110 is that it combines a water-soluble form of panobinostat with a CED device that delivers the drug directly to the brain tumor through a surgically implanted catheter and refillable pump. Biodexa says the drug achieves high drug concentrations within the tumor while limiting systemic exposure. The proof-of-concept phase 1 clinical trial of MTX110 took place at the University of California San Francisco with patients battling DMG. The trial produced promising results with a median overall survival of 26 months, compared to a historical overall survival rate of 10 months. Similarly, a phase 1 trial involving newly diagnosed DMG patients at Columbia University Irving Medical Center also had encouraging outcomes, with MTX110 treatment increasing median overall survival to 16 months from a historical overall survival rate of 10 months. The findings from this study will be presented at the 21st International Symposium on Pediatric Neuro-Oncology (June 28 - July 2, 2024), and the company may potentially continue developing the drug in this indication in a phase 2 study. Biodexa reports that the ongoing MAGIC-G1 phase 1 trial in recurrent GBM patients at Duke Cancer Institute and Baptist MD Anderson Cancer Center is currently showing considerable progress with completion of recruitment for cohort A of the study. The first patient survived for 12 months, and three patients currently remain in the study. The expected topline results for progression-free survival from cohort A will be available in Second Quarter of 2024. The retrospective analysis of 299 patients with similar recurrent GBM disease showed a median overall survival of only 6.5 months after the recurrence of GBM cancer. Biodexa is hopeful MTX110 could potentially help extend patient life, offering much-needed hope to patients and their families. The company's delivery method may also help prevent full-body exposure, which could minimize negative side effects. For cancers with such high mortality rates, any amount of extra time with a better quality of life is groundbreaking.공고 • Feb 24Biodexa Pharmaceuticals plc Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D UpdateBiodexa Pharmaceuticals PLC announced an R&D update including positive top-line clinical trial results of a recently completed Phase 1 study of MTX110 in patients with diffuse midline glioma, or DMG, and results of a preclinical experiment designed to demonstrate tolimidone's potential for beta cell proliferation in an in vitro model. MTX110: In an investigator initiated study conducted by Columbia University Irving Medical Center, patients newly diagnosed with DMG were administered MTX110 via convection enhanced delivery ("CED") using a subcutaneous pump connected to a catheter directly implanted into the pons in a 3+3 dose-escalating design (NCT 04264143). As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary objective of the study was safety and tolerability and, accordingly, the number of infusions was limited to two, each of 48 hours, 7 days apart. Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2). One patient in the 60 M group suffered a severe adverse event assessed by the investigators as not related to the study drug but related to the infusion and tumor anatomy. Although the study was not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months. This compares favourably with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Study investigators are planning to present detailed results of the trial at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) being held on June 28-July 2, 2024 in Philadelphia, PA. On the Company's behalf, a CRO conducted an in vitro experiment designed to demonstrate tolimin's potential for beta cell proliferation using reaggregated pancreatic islets. The results of the experiment were inclusive in that they did not correlate with the results previously seen in vitro and in vivo studies of tolimidone. The Company believes there are a few possible explanations to the outcome of this in vitro study and accordingly, plans to move ahead rapidly with an in vivo preclinical study with similar objectives while continuing preparations for its planned Phase IIa open-label study of tolimidone in patients with Type 1 diabetes due to start recruitment later this year.공고 • Feb 09Biodexa Pharmaceuticals plc Reports 12 Month Survival in Magic-G1 Study of Mtx110 in Recurrent Glioblastoma PatientsBiodexa Pharmaceuticals PLC provided survival updates from its MAGIC-G1 study (NCT05324501) of MTX110 in patients with recurrent glioblastoma (“rGBM”) being conducted at Duke Cancer Institute and Baptist MD Anderson Cancer Center. In October 2023, Biodexa announced completion of recruitment of Cohort A of an ongoing open-label Phase I dose-escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery via implanted refillable pump and catheter. Because no drug-related adverse events were observed within the first 30 days from start of treatment, the minimum number of four patients were recruited into Cohort A. Patient #1 received weekly infusions of 60µM of MTX110 and survived for 12 months from the start of treatment (OS=12). Patients #2, 3 and 4 each received weekly infusions of 90µM of MTX110, the expected optimum dose, and remain in the study. GBM universally recurs and once it does median overall survival according to a retrospective analysis of 299 patients reported in the Journal of Neuro-Oncology is 6.5 months1. Currently, no standard of care is established for rGBM.공고 • Dec 29Biodexa Appoints Ann Merchant to the Board of DirectorsBiodexa Pharmaceuticals PLC announced the appointment of Ann Merchant to the Board of Directors of the Company as Non-executive Director with effect from 31 December 2023. Since 2018, Ann Merchant has served as Vice President for MorphoSys, and currently as Head of Global Supply Chain and External Operations. Prior to joining MorphoSys, from September 2011 to August 2018, Ms. Merchant served as the President of Schreiner Medipharm. Between 1994 and 2011, Ms. Merchant held various roles at Amgen in Europe and the US, including Vice President, Head of International Supply Chain and Site Head between 2007 and 2011. Ms. Merchant is also a Non-executive Director of Alvotech S.A. Ms. Merchant is a U.S citizen and holds a Bachelor of Science in Languages from Georgetown University and an MBA from the Henley Business School.공고 • Dec 21Biodexa Pharmaceuticals Plc has completed a Composite Units Offering in the amount of $5.217389 million.Biodexa Pharmaceuticals Plc has completed a Composite Units Offering in the amount of $5.217389 million. Security Name: Class A Units Security Type: Equity/Derivative Unit Securities Offered: 697,614 Price\Range: $2 Discount Per Security: $0.16 Security Name: Class B Units Security Type: Equity/Derivative Unit Securities Offered: 1,911,176 Price\Range: $1.9999 Discount Per Security: $0.159992공고 • Oct 05Biodexa Pharmaceuticals plc Completes Recruitment of Cohort A in Study of Mtx110 in Patients with Recurrent GlioblastomaBiodexa Pharmaceuticals PLC announced that it has completed recruitment into cohort A of its ongoing Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in patients with recurrent glioblastoma (rGBM). MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts (A and B), with a minimum of four patients in each; while patients in both cohorts receive MTX110 via intermittent repeated CED infusions, patients in the B cohort will be allowed CED catheter repositioning upon first in-study clinical and/or radiographic confirmed progression. Following review by the Data Safety Monitoring Board (DSMB), the dose was escalated to 90µM after the first patient in cochort A and, because there have been no dose-limiting toxicities, recruitment into this cohort has concluded with the minimum of four patients. Patient 1 received 13 treatment cycles over 19 weeks of study treatment period, whereas patient 2 received 10 cycles over 13 weeks of study treatment period; patient 3 has, to date, received five cycles of treatment. The fourth patient underwent surgery on October 2, 2023 and will receive their first cycle of treatment imminently. Enrolment in cohort B will commence upon approval by the study DSMB, which is anticipated to be received towards the end of October 2023. In addition, the Company is planning to add two more investigational centres into the study with activation expected in December 2023 and January 2024, respectively.공고 • Sep 22Biodexa to Present Recruitment and Treatment Update in Phase 1 Study of Mtx-110 (Magic-G1 Study) in Patients with Recurrent Glioblastoma At 2023 Annual European Association of Neuro-Oncology Meeting (Eano)Biodexa Pharmaceuticals PLC announced that it will be presenting an update on the recruitment and treatment of patients in the ongoing Phase 1 study of MTX-110 (also known as MAGIC-G1 study) in patients with recurrent glioblastoma (rGB) during a poster session on 22 September 2023, at the 2023 annual EANO meeting in Rotterdam, the Netherlands (NCT 05324501). MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX-110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; while patients in both cohorts will receive MTX-110 via intermittent repeated CED infusions, patients in the second cohort will be allowed CED catheter repositioning upon first in-study clinical and/or radiographic confirmed progression. As of the time of this announcement, three patients have been dosed in the first cohort of the study. No dose-limiting toxicities have been observed at any dose level; and all study-related, non-surgical adverse events were grade 1 or 2 and correlated with the location of the lesion being treated. Patient 1 has received 13 treatment cycles over 19 weeks of study treatment period, whereas patient 2 received 10 cycles over 13 weeks of study treatment period; patient 3 has been recently enrolled and continues to receive treatment. GB is the most common and devastating primary malignant brain tumour in adults encompassing 14.3% of all primary brain and central nervous system neoplasms(1). With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people in the USA will be diagnosed with GB per annum. Standard of care for treatment of GB is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune® device. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality. The median survival from initial diagnosis is less than 21 months(2). Currently, no standard of care is established for rGB. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501), paediatric DMG (NCT04264143) and recurrent medulloblastoma (NCT04315064). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG and GBM tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).공고 • Jul 25Biodexa Regain Compliance with Nasdaq Minimum Bid Price RequirementBiodexa Pharmaceuticals PLC announced that, on July 20, 2023, it received a notification from The Nasdaq Stock Market LLC (“Nasdaq”) confirming the Company has cured the previously disclosed bid price deficiency, and that the Company is in compliance with all applicable listing standards. The Company’s securities will continue to be listed and traded on Nasdaq and the previously announced hearing with the Nasdaq Hearing Panel is cancelled. Nasdaq further notified the Company that it will be subject to a Mandatory Panel Monitor for a period of one year from July 20, 2023. If, within that one-year monitoring period, the Listing Qualifications Staff finds the Company out of compliance with the rules that was subject to the previous exception, the Staff will issue a delisting determination letter and the Company will have the opportunity to request a hearing with the Nasdaq Hearings Panel.공고 • Jul 11Biodexa Ltd Announces Completion of Enrolment and Treatment in the Phase 1 Study of Mtx110 in the Treatment of Children with Newly Diagnosed Diffuse Midline Gliomas (Dmgs)Biodexa Ltd. announced completion of enrolment and treatment of nine paediatric patients into the ongoing investigator-sponsored Phase I study of MTX-110 in newly diagnosed DMGs (NCT 04264143). All of the patients (age range 4-17 years) were enrolled at the Columbia University Irving Medical Centre and received radiation therapy as per the institution's standard of care. Each patient subsequently underwent surgery with implantation of an intratumoral catheter and a programmable subcutaneous pump and 8 out of 9 have received two infusions of MTX110 via convection-enhanced delivery (CED) separated by a period of 1 week. concentrations of 30, 60 or 90 uM were delivered with no intra-patient dose escalation. No dose limiting toxicities related to the study drug have been reported in the study. Full study results are expected to be made public around the 1st quarter of 2024. About DMG: DMG is a primary brain tumour arising in the midline structures of the brain including the pons of the brain stem, is diffusely infiltrating and cannot be surgically removed. Occurring mostly in children, the median survival rate in a cohort of 316 cases was 10.0 months and overall survival at 12 months was 35% (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Although radiotherapy prolongs survival, the majority of patients die within one year following diagnosis. Systemic chemotherapy is ineffective, often due to an inability of agents to cross the blood-brain barrier. Approximately 1,100 (data on file) individuals are diagnosed with DIPG worldwide each year. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-b-cyclodextrin (HPBCD), that enables CED at potentially therapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®?) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501), paediatric DMG (NCT04264143) and recurrent medulloblastoma (NCT04315064). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG and GBM tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).공고 • Jul 08Biodexa Pharmaceuticals Announces Results of Appeal of Delisting DeterminationBiodexa Pharmaceuticals PLC announced that, on July 5, 2023, The Nasdaq Stock Market LLC’s (“Nasdaq”)Hearings Panel notified the Company that, in connection with its request for a temporary exception to regain compliance with Nasdaq’s requirement that the closing bid price of its securities remain at $1.00 or higher as required by Nasdaq Listing Rule 5810(c)(3)(A) (the “Minimum Bid Price Rule”), and further to the Company’s recently completed consolidation of its American depositary receipts, which had the effect of a one-for-80 reverse split, it has been granted an exception until July 18, 2023 to demonstrate compliance with the Minimum Bid Price Rule. If the Company’s securities fail to regain compliance with the Minimum Bid Price Rule by that date, Nasdaq will delist the securities.공고 • Jul 07Biodexa Pharmaceuticals plc Announces the Publication of the Results of an Investigator-Initiated Phase I Study Pnoc015Biodexa Pharmaceuticals PLC announced the publication of the results of an investigator-initiated Phase I study PNOC015 (also known as MTD-201) of MTX110 in the treatment of pediatric patients with DMG (formerly known as Diffuse Intrinsic Pontine Glioma, or DIPG) in the Journal of Neuro-Oncology (NCT 03566199). The study recruited seven pediatric patients with confirmed diagnosis of DMG, after radiation therapy. Convection Enhanced Delivery (CED) of MTX110 at doses escalating from 30uM to 90mM was performed, with a total of 48 infusions across all patients. The study has demonstrated acceptable safety profile of the treatment (three patients reported dose-limiting toxicities) and encouraging efficacy with median overall survival (OS) of 26.1 months comparing favourably with historical data of OS of 10.0 months.공고 • Jun 21Biodexa Pharmaceuticals Receives a Period of 180 Calendar Days to Return to Compliance with the Minimum Bid Price RuleOn June 20, 2023, Biodexa Pharmaceuticals PLC announced that, on June 16, 2023, it appealed the Staff Determination from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’), to a Hearings Panel (the ‘Panel’) to delist the company’s securities from The Nasdaq Capital Market because the company’s securities have had a closing bid price below $0.10 for ten consecutive trading days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii)(1) (the ‘$0.10 Rule’). In addition to the $0.10 Rule delisting notice, the company also currently fails to satisfy the requirement that the closing bid price of its securities remain at $1.00 or higher as required by Nasdaq Listing Rule 5810(c)(3)(A) (the ‘Minimum Bid Price Rule’). The company has received a period of 180 calendar days to return to compliance with the Minimum Bid Price Rule, which compliance period expires on July 31, 2023. If the company’s securities fail to regain compliance with the Minimum Bid Price Rule, Nasdaq will have an additional basis for delisting the securities. As noted in the Company’s press release on June 15, 2023, the hearing request will stay the suspension of the Company’s securities and the filing of the Form 25-NSE pending the Panel’s decision. In connection with its request for a hearing, the Company has also requested that the Staff Determination be further stayed pending the resolution of the Company’s appeal. Subsequent to the Company’s request for a hearing, Nasdaq notified the Company that the Panel would hear its appeal on August 10, 2023. The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirements under the Nasdaq Listing Rules for continued listing on Nasdaq prior to the hearing.공고 • Jun 16Biodexa Pharmaceuticals Receives Staff Determination Letter from Nasdaq to Delist its Securities from The Nasdaq Capital Market Regarding Non-Compliance with the Minimum Bid Price RequirementsOn June 15, 2023, Biodexa Pharmaceuticals Plc announced that on June 14, 2023, it received a Staff determination letter (the ‘Letter’) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market because the Company’s securities have had a closing bid price below $0.10 for ten consecutive trading days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii) (the ‘$0.10 Rule’). In addition to the $0.10 Rule delisting notice, the Company also currently fails to satisfy the requirement that the closing bid price of its securities remain at $1.00 or higher as required by Nasdaq Listing Rule 5810(c)(3)(A) (the ‘Minimum Bid Price Rule’). The Company has received a period of 180 calendar days to return to compliance with the Minimum Bid Price Rule, which compliance period expires on July 31, 2023. If the Company’s securities fail to regain compliance with the Minimum Bid Price Rule, Nasdaq will have an additional basis for delisting the securities. Pursuant to the Letter, unless the Company requests an appeal of the Letter, trading of the Company’s American depositary shares (‘ADSs’) will be suspended at the opening of business on June 23, 2023, and a Form 25-NSE will be filed with the Securities and Exchange Commission (the ‘SEC’), which will remove the Company’s securities from listing and registration on the Nasdaq Stock Market. The Company plans to appeal the Staff’s determination to a Hearings Panel (the ‘Panel’). A hearing request will stay the suspension of the Company’s securities and the filing of the Form 25-NSE pending the Panel’s decision. The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirements under the Nasdaq Listing Rules for continued listing on Nasdaq.공고 • Jun 08Biodexa Pharmaceuticals Plc announced that it has received $3.320388 million in fundingOn June 7, 2023, Biodexa Pharmaceuticals Plc closed the transaction. The transaction included participation from 15 investors.공고 • May 23Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 14, 2023Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 14, 2023, at 11:00 Coordinated Universal Time. Location: 1 Caspian Point Caspian Way, Cardiff CF10 Wales Greater London United Kingdom공고 • May 19Biodexa Pharmaceuticals Plc (NasdaqCM:BDRX) entered into non-binding letter of intent to acquire Varian Biopharmaceuticals Inc. for $3.7 million.Biodexa Pharmaceuticals Plc (NasdaqCM:BDRX) entered into non-binding letter of intent to acquire Varian Biopharmaceuticals Inc. for $3.7 million on May 18, 2023. Under the non-binding letter of intent, Varian equity and debt holders will receive 10 million of Biodexa's American Depositary Shares (“ADSs”) at close as initial consideration. Varian Securityholders will receive up to a further 6 million ADSs, issuable in two phases: 3 million upon the commencement of the first pivotal registration study of a Varian product and an additional 3 million upon the first FDA approval of a Varian product. On a pro forma basis, prior to the planned financing, Varian Biopharmaceuticals securityholders will own approximately 34% of the post-acquisition company. The transaction is subject to shareholder approval, and appropriate representations and warranties by the parties.Reported Earnings • May 01Full year 2022 earnings released: UK£0.077 loss per share (vs UK£1.36 loss in FY 2021)Full year 2022 results: UK£0.077 loss per share. Revenue: UK£699.0k (up 21% from FY 2021). Net loss: UK£7.66m (loss widened 40% from FY 2021).공고 • Feb 19Midatech Pharma plc announced that it has received $5.999223 million in fundingOn February 17, 2023, Midatech Pharma plc closed the transaction. The transaction included participation from six investors.공고 • Feb 04Midatech Pharma Announces Receipt of NASDAQ NoticeMidatech Pharma plc announced that it received written notification from The NASDAQ Stock Market LLC, dated 31 January 2023, stating that the Company is not in compliance with the minimum bid price requirement set forth in NASDAQ's rules for continued listing on The NASDAQ Capital Market. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's American Depositary Shares (the "Depositary Shares"), each representing 25 ordinary shares of the Company, for the 30 consecutive business days beginning14 December2022, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing of the Depositary Shares, and they will continue to trade on The NASDAQ Capital Market under the symbol "MTP." In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until 31 July 2023 (the "Compliance Period"), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Depositary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the Compliance Period. If the Depositary Shares do not regain compliance with the minimum bid price requirement during the Compliance Period, the Company may be eligible for an additional grace period of 180 calendar days provided that the Company satisfies NASDAQ's initial listing standards for listing on The NASDAQ Capital Market, other than the minimum bid price requirement, and provides written notice to NASDAQ of its intention to cure the delinquency during the second grace period. If the Company does not regain compliance during the initial grace period and is not eligible for an additional grace period, NASDAQ will provide written notice that the Depositary Shares are subject to delisting from The NASDAQ Capital Market. In that event, the Company may appeal such determination to a hearing panel. The Company intends to monitor the bid price of its Depositary Shares during the Compliance Period and will consider taking such actions as may be necessary and appropriate to achieve compliance with continued listing requirements prior to the expiration of all available grace periods. The Company's business operations are not affected by the receipt of the Notification Letter. The Company's ordinary shares are admitted to trading on the AIM Market of the London Stock Exchange, and the Notification Letter does not affect the Company's compliance status with the AIM Rules for Companies.공고 • Jan 12Midatech Pharma PLC Announces Planned Dose Escalation in MTX-110 Phase 1 StudyMidatech Pharma PLC announced that following completion of one month of treatment with MTX-110 in the first patient, its Phase I study of MTX-110 in recurrent glioblastoma (rGB) (NCT 05324501) will continue with a planned dose escalation following a positive recommendation from the study's Data Safety Monitoring Board (DSMB). The Phase I study, the MAGIC-G1 study, is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX-110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort will receive MTX-110 only and the second cohort will receive MTX-110 in combination with lomustine. The first patient in the study was dosed at 60uM of MTX-110 via direct-to-tumour delivery and has received four 48-hour infusions over a period of four weeks. No treatment-associated adverse events were noted in the patient during this period. Following successful completion of the first month of treatment, the DSMB reviewed the available data on 11 January 2023 and recommended dose escalation in the study to 90uM. This dose is expected to be the optimal one of MTX-110 and is the one currently being used in the ongoing Phase I study of patients with diffuse intrinsic pontine glioma (DIPG) at the Columbia University, USA. Patient 1 continues treatment as per the study protocol and patient 2 is expected to start treatment by the end of January 2023 and will receive the 90uM dose. GB is the most common and devastating primary malignant brain tumour in adults encompassing 14.3% of all primary brain and central nervous system neoplasms. With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people in the USA will be diagnosed with GB per annum. Standard of care for treatment of GB is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune® device. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality. The median survival from initial diagnosis is less than 21 months. Currently, no standard of care is established for rGB. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favorable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).공고 • Dec 15Midatech Pharma plc announced that it expects to receive $9.6 million in fundingMidatech Pharma plc announced a private placement of common shares for gross proceeds of $9,600,000 on December 13, 2022. The transaction is expected to close in the first quarter of 2023 with acquisition of Bioasis Technologies Inc. The transaction is subject to approval from the shareholders of the company. The transaction has been approved by the board of directors of Bioasis Technologies Inc.공고 • Nov 14Midatech Pharma plc Announces First Patient Enrolled in Phase 1 Study of MTX-110Midatech Pharma PLC announced the enrolment of the first patient into its Phase 1 study of MTX110 in recurrent glioblastoma (rGB) (NCT 05324501) at the Preston Robert Tisch Brain Tumor Center at Duke University, USA. The Phase I study is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort will receive MTX110 only and the second cohort will receive MTX110 in combination with lomustine. Midatech has previously reported encouraging results from a Phase I study of MTX110 in diffuse intrinsic pontine glioma conducted by University of California, San Francisco with an additional Phase I study of MTX110 in DIPG conducted by Columbia University expected to report shortly. In addition, a Phase I study of MTX110 in medulloblastoma is being undertaken at the University of Texas. MTX110 has been granted Orphan Drug and Fast Track designations by the FDA and Orphan Medicinal Product designation by EMA.공고 • Oct 19Midatech Pharma plc Announces Receipt of Nasdaq NotificationMidatech Pharma plc announced that further to the Company's announcement on April 14, 2022, it has received written notification dated October 10, 2022 (the "Notification Letter") from The NASDAQ Stock Market LLC ("NASDAQ") that for 10 consecutive business days, from September 26, 2022 to October 9, 2022, the closing bid price of the Company's American Depositary Shares had been at $1.00 per share or greater and, accordingly, the Company has regained compliance with NASDAQ Listing Rule 5550(a)(2).공고 • Jun 21Midatech Pharma PLC Announces Directorate ChangeMidatech Pharma PLC announced the appointment of Dr. Stephen Barry Parker as a Director of the Company and Non-Executive Chairman of the Board with immediate effect. Stephen Parker has over 30 years' experience in leadership roles both in the healthcare industry and in advisory roles. Currently, he is Chairman of Sareum Holdings plc and Drishti Discoveries Ltd., a Non-Executive Director of MGC Pharmaceuticals Ltd. and an Executive Director of sp2 Consulting Limited. Previously, Stephen held a number of executive and board positions at various public and private biotech companies and senior roles at leading investment banks. Stephen has an MBA from City University and a D.Phil. in biochemistry from Oxford University. Dr. Parker is taking over from Rolf Stahel, who has resigned as a Director of the Company and stepped down as Chairman in line with his proposed retirement, previously announced on 10 June 2022. Dr. Stephen Barry Parker, aged 63: Current Directorships and Partnerships - Sareum Holdings Plc, Sareum Limited, sp2 Consulting Limited, sp2 Asset Management Ltd, MGC Pharmaceuticals Limited, Drishti Discoveries Ltd. and Eternans Ltd. Previous Directorships and Partnerships (past 5 years) - Silence Therapeutics Plc, Liverpool Chirochem Limited and Albucasis Limited. Dr. Parker was formerly a director of Celtic Pharma Development UK Plc, Xenova Group Limited and Xenova Limited, each of which were subsidiaries of Celtic Pharma GP Limited and were placed into creditors voluntary liquidation in April 2014. As of the date of this announcement, Dr. Parker holds no ordinary shares or options in the Company.공고 • Jun 11Midatech Pharma plc Announces MTX110 Study to be Presented at ISPNO 2022Midatech Pharma PLC announced that investigators from Columbia University Irving Medical Center and New York-Presbyterian will present interim results from their ongoing Phase 1 study on Midatech's MTX110 in Diffuse Intrinsic Pontine Glioma ("DIPG") at The International Symposium on Pediatric Neuro-Oncology ("ISPNO 2022") that will take place on 12-15 June 2022 in Hamburg, Germany. The presentation is titled: "A Phase I study examining the feasibility of intermittent convection-enhanced delivery (CED) of MTX110 for the treatment of children with newly diagnosed diffuse midline gliomas." The presentation will take place on 13 June 2022 in the neurosurgery section of the conference, at 10.30 am CEST. The investigators will show first data on seven out of the ten planned patients on the safety of MTX110 (a water-soluble formulation of panobinostat) in patients with DIPG. This study uses an implantable pump and catheter system that allows for continuous intratumoral administration of the study drug without the need for repeated surgery. The study continues its recruitment. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines.공고 • Jun 10Midatech Pharma plc Announces Retirement of Rolf StahelMidatech Pharma PLC announced that Rolf Stahel, Chairman and non-executive director, intends to retire after the Company's Annual General Meeting on 20 June 2022 It is expected that Dr. Stephen Parker will be appointed as non-executive Chairman of the Board, following the AGM. Stephen Parker has over 30 years' experience in leadership roles both in the healthcare industry and in advisory roles. Currently, he is Chairman of Sareum Holdings plc and Drishti Discoveries Ltd, a Non-Executive Director of MGC Pharmaceuticals Ltd. and an Executive Director of sp2 Consulting Limited. Previously, Stephen held a number of executive and board positions at various public and private biotech companies and senior roles at leading investment banks. Stephen has an MBA from City University and a D.Phil. in biochemistry from Oxford University.공고 • Jun 02Midatech Pharma plc Announces Fast Track Designation Granted to Mtx110 Development for the Treatment of Recurrent GlioblastomaMidatech Pharma plc announced that upon submitting an application to the U.S. Food and Drug Administration FDA, its development programme of MTX110 for the treatment of recurrent glioblastoma has been granted Fast Track designation by the agency. Fast Track is a process designed to facilitate the development and expedite the review of treatments for serious conditions and that potentially address unmet medical needs. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.공고 • May 25Midatech Pharma plc, Annual General Meeting, Jun 20, 2022Midatech Pharma plc, Annual General Meeting, Jun 20, 2022, at 13:00 Coordinated Universal Time. Location: 1 Caspian Point, Caspian Way, Cardiff CF10 4DQ Cardiff United Kingdom공고 • Apr 15Midatech Pharma Received Written Notification from Nasdaq Stating Company Is Not in Compliance with Minimum Bid Price RequirementMidatech Pharma plc announces that it received written notification (the "Notification Letter") from The NASDAQ Stock Market LLC ("NASDAQ"), dated 13 April 2022, stating that the Company is not in compliance with the minimum bid price requirement set forth in NASDAQ's rules for continued listing on The NASDAQ Capital Market. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's American Depositary Shares (the "Depositary Shares"), each representing five ordinary shares of the Company, for the 30 consecutive business days beginning 2 March 2022, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing of the Depositary Shares, and they will continue to trade on The NASDAQ Capital Market under the symbol "MTP". In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until 10 October 2022 (the "Compliance Period"), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Depositary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the Compliance Period. If the Depositary Shares do not regain compliance with the minimum bid price requirement during the Compliance Period, the Company may be eligible for an additional grace period of 180 calendar days provided that the Company satisfies NASDAQ's initial listing standards for listing on The NASDAQ Capital Market, other than the minimum bid price requirement, and provides written notice to NASDAQ of its intention to cure the delinquency during the second grace period. If the Company does not regain compliance during the initial grace period and is not eligible for an additional grace period, NASDAQ will provide written notice that the Depositary Shares are subject to delisting from The NASDAQ Capital Market. In that event, the Company may appeal such determination to a hearing panel. The Company intends to monitor the bid price of its Depositary Shares during the Compliance Period and will consider taking such actions as may be necessary and appropriate to achieve compliance with continued listing requirements prior to the expiration of all available grace periods. The Company's business operations are not affected by the receipt of the Notification Letter.공고 • Dec 14Midatech Pharma PLC Announces Investigational New Drug Application for Study of MTX110 in Recurrent Glioblastoma (GBM) Becomes EffectiveMidatech Pharma PLC announced that its Investigational New Drug (IND) application for a Phase 1 study of MTX110, a panobinostat complex to be administered by convection enhanced delivery in patients with recurrent glioblastoma multiforme (rGBM), has been cleared by the US FDA. Accordingly, Midatech has initiated preparations for a study start in the first half of 2022. Employing the Company's MidaSolve™ technology, MTX110 solubilises panobinostat, a histone deacetylase (HDAC) inhibitor currently used in the treatment of multiple myeloma. In a liquid formulation as MTX110, panobinostat can be delivered directly to a patient's tumour under constant pressure via a catheter system (Convection Enhanced Delivery, or "CED") thereby bypassing the blood-brain barrier and allowing for high drug concentrations and broader drug distribution in and around the tumour while simultaneously minimising systemic toxicity and other side effects. Panobinostat has demonstrated high potency against patient-derived tumour cells in vitro and in vivo models. GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumours recur. There are approximately 2-3/100,000(1) diagnoses of GBM per annum. Survival with standard of care treatment ranges from approximately 13 months in unmethylated MGMT patients to approximately 30 months in highly methylated MGMT patients(2). Glioblastoma is an intractable brain cancer. The primary objective of the Phase I study will be to assess the safety and tolerability of MTX110 in patients with rGBM. The study is expected to include two clinical centres in the US and to begin recruiting H1 2022.공고 • Jun 30Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £10 million.Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £10 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 35,087,720 Price\Range: £0.285 Transaction Features: Regulation S; Subsequent Direct Listing공고 • Jun 18+ 1 more updateMidatech Pharma plc Announces Shut Down of its Bilbao OperationsMidatech Pharma plc announced breakthrough in vitro data which demonstrate Q-Sphera's potential to formulate proteins into long-acting injectable products, as well as significant progress across multiple other programmes. In the 13 months since the announcement of a Strategic Review, the Company has shut down its Bilbao operations, thereby halving its monthly cash burn rate and pivoted from a largely singular focus on one Phase III ready asset (MTD201, Q-Sphera octreotide) to "multiple shots on goal" with an expanded pipeline of nine earlier stage programmes. The Company's strategy is to develop each programme to proof of concept before seeking Licensing partners to undertake later stage development, manufacturing and commercialisation.공고 • Dec 13Midatech Pharma PLC to Present MTX110 Programmes at The International Symposium on Pediatric Neuro-Oncology, Karuizawa, JapanMidatech Pharma PLC announced that its University collaborators will be presenting three sets of research findings on MTX110 at The International Symposium on Pediatric Neuro-Oncology on 13-16 December 2020 in Karuizawa, Japan (to be held online this year). The first two presentations, by Columbia University Medical Center and University of Texas Health Center at Houston, are being presented for the first time. The third presentation, by the Pacific Pediatric Neuro-Oncology Consortium, was also presented at last months' Society of Neuro-Oncology (SNO2020) conference. Abstract details and links to the posters are provided below: A Phase I Study Examining the Feasibility of Intermittent Convection-Enhanced Delivery (CED) of MTX110 for the Treatment of Children with Newly Diagnosed Diffuse Intrinsic Midline Gliomas (ABSTRACT DDEL-07, Page iii284) - Lead Author: Dr Stergios Zacharoulis MD, Columbia University Medical Center, New York, USA. In the study: Patients are receiving continuous CED infusions of MTX110 for 48 hours on two cycles separated by 5 to 7 days; 3 patients have been treated so far at 30 microM; No Serious Adverse Events; Toxicity: Grade II diplopia (1) Grade I sensation (n=1), headache Grade II (n=2); and 1 patient progressed 8 months post treatment. High Dose MTX110 (Soluble Panobinostat) Safely Administered into the Fourth Ventricle in a Non-Human Primate Model (ABSTRACT DDEL-09, Page iii285) - Lead Author: Dr David Sandberg MD, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, USA. Conclusions of the presentation are: Fourth ventricle catheters were successfully instilled to enable locoregional infusion of MTX110; MTX110 was well-tolerated, with no evidence of toxicity; Drug levels in the CNS reached a therapeutic range; and The data support the safety of administration of MTX110 via the fourth ventricle; and Clinical trial in recurrent medulloblastoma patients is ongoing. PNOC015: An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection-Enhanced Delivery (CED) in Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated with External Beam Radiation Therapy (ABSTRACT EPCT-12, Page iii306).공고 • Oct 20Midatech Pharma plc Announces Headline Results of MTX110 Phase I DIPG StudyMidatech Pharma PLC, announced encouraging headline results from a Phase I study at the University of California, San Francisco in patients with Diffuse Intrinsic Pontine Glioma. The primary endpoint of the study was to determine the dosage regimen to be used in a proposed Phase II study of the safety and efficacy of MTX110 in patients with DIPG. Preliminary high-level data from the UCSF study supports a dose of between 60µM and 90µM of MTX110, depending upon patient tolerance over the course of 12 infusions in Phase II. total, seven patients were recruited into the UCSF study. Patients were newly diagnosed with DIPG and received focal external beam radiation therapy four to 14 weeks before commencement of MTX110 treatment. Eligibility required a pontine location of the tumour with diffuse involvement of at least two thirds of the pons and no evidence of metastatic disease. Patients were not excluded by total tumour volume. MTX110 was administered directly into the tumour via a micro-catheter using convection enhanced delivery ("CED") with gadolinium-enhanced intra-operative MRI to guide and track drug distribution to the tumour. Patients could receive up to 12 cycles of treatment every four to eight weeks. The dose was escalated between and within patients as tolerated initially by increasing the infusion volume at a concentration of 30µM MTX110 and then with higher drug concentrations of 60µM and 90µM as the sixth and seventh dose increments, respectively. At the interim cut-off date (30 September 2020), median overall survival based on Kaplan Meier analysis was 26.06 months (CI 11.3 - 26.06 months) and overall survival at 12 months (OS12) was 71.4% (five of seven patients alive). Three patients remain alive and continue to be monitored. Survival was not an endpoint of the UCSF study nor was the study powered for statistical significance and therefore no conclusions as to the impact of MTX110 on overall survival rates can be drawn from these data. The proposed Phase II trial is expected to evaluate overall survival at 12 months as the primary endpoint in 19 evaluable patients. The planned design is single arm and statistically powered for comparisons with defined historical survival data. MTX110 is expected to be delivered using an alternative CED catheter system that enables regular drug infusions directly into the tumour without a need for repeated surgery.공고 • Aug 28Midatech Pharma plc to Report First Half, 2020 Results on Sep 10, 2020Midatech Pharma plc announced that they will report first half, 2020 results on Sep 10, 2020공고 • Jul 31Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £5 million.Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 18,518,518 Price\Range: £0.27 Transaction Features: Subsequent Direct Listing매출 및 비용 세부 내역Biodexa Pharmaceuticals가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이BST:5MPA 매출, 비용 및 순이익 (GBP Millions)날짜매출순이익일반관리비연구개발비31 Dec 221-85530 Sep 221-74530 Jun 221-53531 Mar 221-53531 Dec 211-53530 Sep 211-74230 Jun 211-83031 Mar 210-154031 Dec 200-225030 Jun 200-225031 Mar 201-165031 Dec 191-94030 Jun 192-94031 Mar 192-104031 Dec 182-104030 Jun 181-114031 Mar 181-114031 Dec 171-124030 Sep 17-3-1-7-530 Jun 174-1810631 Mar 176-1914731 Dec 161-63030 Sep 165-17121030 Jun 164-1313631 Mar 163-129631 Dec 151-103930 Sep 151-106530 Jun 150-117431 Mar 150-106431 Dec 140-94430 Sep 140-74330 Jun 140-52331 Mar 140-42331 Dec 130-423양질의 수익: 5MPA 은(는) 현재 수익성이 없습니다.이익 마진 증가: 5MPA는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: 5MPA는 수익성이 없지만 지난 5년 동안 연평균 9.8%의 속도로 손실을 줄였습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 5MPA의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: 5MPA은 수익성이 없어 지난 해 수익 성장률을 Biotechs 업계(1.2%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: 5MPA는 현재 수익성이 없으므로 자본 수익률이 음수(-242.13%)입니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2023/09/27 04:59종가2023/06/30 00:00수익2022/12/31연간 수익2022/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Biodexa Pharmaceuticals Plc는 3명의 분석가가 다루고 있습니다. 이 중 명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Aydin HuseynovLadenburg Thalmann & CompanyJens LindqvistSinger Capital MarketsDavid BautzZacks Small-Cap Research
Reported Earnings • May 01Full year 2022 earnings released: UK£0.077 loss per share (vs UK£1.36 loss in FY 2021)Full year 2022 results: UK£0.077 loss per share. Revenue: UK£699.0k (up 21% from FY 2021). Net loss: UK£7.66m (loss widened 40% from FY 2021).
공고 • Aug 28Midatech Pharma plc to Report First Half, 2020 Results on Sep 10, 2020Midatech Pharma plc announced that they will report first half, 2020 results on Sep 10, 2020
공고 • Oct 04Biodexa Pharmaceuticals PLC Provides Update on Progression Free and Overall Survival in Phase 1 Study of MTX110 in Recurrent GlioblastomaBiodexa Pharmaceuticals PLC announced an update in respect of its open label Phase 1 study of MTX110 in recurrent glioblastoma. In October 2023, the Company announced completed recruitment of four patients into cohort A of its Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in patients with recurrent glioblastoma (rGBM). MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. Patients received MTX110 via intermittent repeated CED infusions. As of today, the status of patients in Cohort A is as follows: Patients #1 and #2 have deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively. Patients #3 and #4 remain in post-study follow-up. Patient #3 had progression free survival (PFS) of six months and OS thus far of 13 months since start of treatment. Patient #4 has not yet had confirmed progression and, as of today, has PFS and OS of 12 months since start of treatment. Glioblastoma (GBM) is the most aggressive central nervous system (CNS) primary malignancy in adults with an annual incidence is approximately 3 per 100,000 population. The standard of care in newly diagnosed GBM includes maximal safe surgical resection, followed by concurrent radiotherapy and temozolomide (TMZ). GBM virtually always recurs with median PFS of 1.5–6.0 months and median OS of 2.0–9.0 months. These interim data in rGBM build on the data announced by the Company on July 2, 2024, and presented at the recent 21st International Symposium on Paediatric Neuro-Oncology (ISPNO 2024) of a Phase 1 study of MTX110 in nine patients with Diffuse Midline Glioma (“DMG”) which showed, after only two infusions and a single patient at optimum dose, median OS of 16.5 months. In an earlier Phase 1 study conducted by the University of California San Francisco of MTX110 in seven patients with DMG which showed median OS of 26.1 months. These data compare favorably with median OS in a cohort of 316 cases of 10.0 months (source: Jansen et al, 2015. Neuro-Oncology 17(1):160-166).
공고 • Sep 16Biodexa Pharmaceuticals plc Announces to Made the Final Match Payment with Respect to A $17 Million Grant from the Cancer Prevention Research Institute of TexasBiodexa Pharmaceuticals PLC announced it made the final match payment of $3.0 million with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT). Familial Adenomatous Polyposis (FAP) is an inherited disease that causes the growth of hundreds or thousands of precancerous polyps throughout the GI tract, putting those afflicted at great risk of developing colon cancer. There is no approved therapeutic option for treating the approximately 100,000 FAP patients in the U.S. and Europe. The current standard of care is active surveillance and surgical resection of the colon and/or rectum. Results of a 12 month Phase 2 clinical trial of eRapa in FAP demonstrated a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. A Phase 3 registrational trial is expected to begin enrollment early next year.
공고 • Aug 31Biodexa Pharmaceuticals Announces Receipt of Nasdaq Delisting Determination - Plans to AppealBiodexa Pharmaceuticals PLC announced that on August 27, 2024, it received a Staff Determination letter (the ‘Letter’) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market because the Company’s securities have had a closing bid price below $1.00 for 30 consecutive business days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5550(a)(2) (the ‘Rule’). Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Rule. However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, and as described in the Letter, unless the Company timely requests a hearing before a Hearings Panel (the ‘Panel’), the Company’s securities would be subject to suspension/delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing.
공고 • Jul 25Biodexa Pharmaceuticals Plc has completed a Follow-on Equity Offering in the amount of $5.009969 million.Biodexa Pharmaceuticals Plc has completed a Follow-on Equity Offering in the amount of $5.009969 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 5,050,808 Price\Range: $0.94 Discount Per Security: $0.0752 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 278,975 Price\Range: $0.9399 Discount Per Security: $0.075192 Transaction Features: Registered Direct Offering
공고 • Jul 12Biodexa Pharmaceuticals Plc Announces Additional Positive Results of Phase 2 Trial of eRapa in Treatment of Precancerous Polyps in the GI Tract - Now 12-Month DataBiodexa Pharmaceuticals PLC is making good progress with eRapa™, its drug to treat Familial Adenomatous Polyposis (FAP). FAP is a mostly inherited condition that puts people at a much greater risk of developing colorectal cancer. Positive 12-month data from a phase 2 clinical trial were recently presented at the 2024 InSIGHT biannual meeting in Barcelona. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients - for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon and/or rectum resected and having to carry a colostomy bag for the remainder of their lives. If left untreated, there is a 100% chance the person will develop colorectal cancer. A Better Way Of Treating FAP: While multiple screenings and surgeries are a way of life for the more than 100,000 people worldwide who suffer from this condition, it doesn't have to remain that way. Biodexa believes eRapa could be the first therapeutic option to treat this precancerous condition, and its data so far backs up that assessment. Results of a 12-month phase 2 clinical trial of eRapa demonstrated an overall 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Even more compelling, of patients in Cohort 2 (treated daily, alternate weeks), 89% of patients were deemed non-progressors at 12 months, with a median reduction in polyp burden of 29%. That could be gaming-changing for FAP patients if it means fewer surgeries with much improved quality of life. The 12-month data demonstrate a longevity of effect of eRapa. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. Too much mTOR has been linked to cancer. Stopping It In Its Tracks: The phase 2 open-label study of 30 adults with FAP was conducted in seven U.S. centers of excellence. The median age of the trial participants was 43 years, with either an intact colon or one with a portion removed and at least ten noncancerous tumors in the rectal remnant. Patients were enrolled in three dosing cohorts, including every other day, daily every other week and daily. Although the primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, patients continued to receive treatment and monitoring for 12 months, leading to the new data. Biodexa said the dosing given to cohort 2 - daily every other week - will likely be the preferred dosage regime for its phase 3 trial, which the company is gearing up to launch soon. That study is planned to be a double-blind placebo-controlled design recruiting approximately 140 high-risk patients diagnosed with germline or phenotypic FAP. Biodexa's phase 2 results were presented at InSIGHT by Carol Burke, M.D., a specialist gastroenterologist at the Cleveland Clinic and a leading authority in FAP. Burke is the Principal Investigator for both the phase 2 study and the upcoming phase 3 study. The phase 2 trial was partially supported by $3 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT). CPRIT is providing a $17 million grant for the phase 3 trial. FAP may be rare, but for the tens of thousands of people suffering from this precancerous condition, there's got to be a better treatment. Biodexa believes it has that with eRapa. The phase 2 trial results seem to lean that way, and with a phase 3 study about to kick off, there may be hope on the horizon for FAP patients.
공고 • Jul 02Biodexa Pharmaceuticals PLC Announces Positive Phase 1 Clinical Data of MTX110 in DMG Brain Cancer Demonstrating Increased Survival Presented at ISPNO 2024Biodexa Pharmaceuticals PLC announced data from a Phase 1 study of MTX110 in Diffuse Midline Glioma (DMG) f/k/a Diffuse Intrinsic Pontine Glioma, or DIPG, an orphan pediatric brain cancer were presented over the weekend at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia, PA. Results of the Phase 1 study: Overall, the treatment was well tolerated by patients. There was one Grade 4 adverse event assessed by the investigators as unrelated to the drug but related to the infusion and tumor anatomy. Most other adverse events were related to infusion and were deemed Grade 2 to 3. Although the study was not powered to reliably demonstrate efficacy, median progression free survival (PFS) was 10 months (range 8 to 20 months) and overall survival (OS) of patients in the study was 16.5 months (range 12 to 35 months). This compares favorably with median OS in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Design of the Phase 1 study: The open label investigator-initiated study was conducted by Columbia University Irving Medical Center in patients newly diagnosed with DMG. Patients were administered MTX110 via convection enhanced delivery (“CED”) using a subcutaneous pump connected to a catheter directly implanted into the pons in a 3+3 dose-escalating design (NCT 04264143). As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary endpoint of the study was to evaluate the safety and maximum tolerated dose with secondary endpoints of Progression Free Survival and Overall Survival. The number of infusions was limited to two, each of 48 hours, seven days apart. Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2). Although the study was not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months. This compares favorably with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). MTX110 in DMG: In October 2020, the Company announced headline results from a Phase I study at the University of California, San Francisco (“UCSF”) in patients with DMG (the “UCSF study” NCT03566199). The primary endpoint of the study was to determine the dosage regimen to be used in a proposed Phase II study of the safety and efficacy of MTX110 in patients with DIPG. Preliminary high-level data from the UCSF study supports a dose of between 60µM and 90µM of MTX110, depending upon patient tolerance over the course of 12 infusions in Phase II. In total, seven patients were recruited into the UCSF study. Patients were newly diagnosed with DMG and received focal external beam radiation therapy four to 14 weeks before commencement of MTX110 treatment. MTX110 was administered directly into the tumour via a micro-catheter using CED with gadolinium-enhanced intra-operative MRI to guide and track drug distribution to the tumour. Patients could receive up to 12 cycles of treatment every four to eight weeks. The dose was escalated between and within patients as tolerated initially by increasing the infusion volume at a concentration of 30µM MTX110 and then with higher drug concentrations of 60µM and 90µM as the sixth and seventh dose increments, respectively. Median overall survival based on Kaplan Meier analysis was 26.06 months. Survival was not an endpoint of the UCSF study nor was the study powered for statistical significance.
공고 • Jun 24Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ At 12 Months in Familial Adenomatous Polyposis (Fap)Biodexa Pharmaceuticals Plc announced that 12 month results of a Phase 2 clinical trial of eRapa™ in Familial Adenomatous Polyposis (NCT04230499) were reported in an oral presentation at the prestigious 2024 InSIGHT bi-annual meeting in Barcelona by Carol Burke, M.D., a specialist gastroenterologist at the Cleveland Clinic and a leading authority in FAP, a mostly genetic disease of precancerous polyps for which the only current remedy is surgical removal of the colon and/or rectum. The Phase 2 study was partially supported by $3 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) under product development awards DP22053 and DP190069. The Phase 3 study of eRapa in FAP is supported by a $17 million grant from CPRIT. Dr. Burke is the Principal Investigator for the both the Phase 2 study and the upcoming Phase 3 registrational study. The open-label study was conducted in seven U.S. centers of excellence in 30 adult patients with median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis and at least 10 adenomas in the rectal remanent (n=24). Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Although the primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, as measured by the aggregate of all polyp diameters, patients continued to receive treatment and monitoring for 12 months (secondary endpoint). Results of the Phase 2 study at 12 months Overall, 21 of 28 (75%) patients were deemed to be non-progressors at 12 months with a median reduction in polyp burden of 17%. In Cohort 2, eight of nine (89)% of patients were deemed non-progressors at 12 months with a median reduction in polyp burden of 9%. Over the course of 12 months, there were four related Grade 3 or higher and one related Serious Adverse Event reported during the trial and 95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance. The Phase 3 registrational study is planned to be a double-blind placebo-controlled design recruiting approximately 140 high risk patients diagnosed with germline or phenotypic FAP. The primary clinical endpoint is likely to be the first progression free survival event which will include major surgery (or referral thereto), polypectomy for advanced neoplasia, advancement of Spigelman stage, diagnosis of high-grade dysplasia or cancer and death from any cause. A $17 million grant from CPRIT will support this study. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035.
공고 • Jun 05Biodexa Pharmaceuticals plc Announces Promising Phase 2 Results for Its Newly In-Liced Drug Erapa for Treating Fam Fam Famic Adenomatous PolyposisBiodexa Pharmaceuticals just announced promising phase 2 results for its newly in-licensed drug eRapa for treating familial adenomatous polyposis (FAP), a mainly genetic disease of the lower GI tract for which there is currently no remedy except surgical removal of the colon and/or rectum. In a clinical trial involving 30 adult patients, three groups received the same dose of the drug but with different regimens over a period of 12 months. Safety, tolerability and changes from baseline in polyp burden (measured by the sum of polyp diameters) were evaluated using endoscopic exams. After the first six months, eRapa appeared to be safe and well-tolerated with a statistically significant 24% reduction (p=0.04) in the total polyp burden compared with baseline, as well as an overall 83% non-progression rate. In other words, the drug has been proven to have a high success rate at stopping the growth of polyps before they get a chance to turn into cancer. Biodexa claims that no drug before has shown such promise in stalling the progression of this disease. The company plans to announce the 12-month results of the phase 2 trial at the InSIGHT scientific conference in Barcelona on June 19-22. FAP is an inherited disease affecting the gastrointestinal tract. If left untreated, it causes hundreds to thousands of polyps to grow inside the colon or rectum. The condition is typically diagnosed in the early teenage years and results in a nearly 100% lifetime risk of colorectal cancer. Treatment options are very limited, with the only current remedy for FAP being surgical removal of the colon and/or rectum, a surgery that always results in the lifelong use of a colostomy bag. With roughly 100,000 individuals in the United States and Europe affected by FAP, there is a considerable need for an effective non-surgical intervention. In April, Biodexa acquired worldwide exclusive rights to eRapa, a drug that the company hopes will delay or prevent the need for surgery. eRapa is a proprietary oral tablet formulation of rapamycin, which is known to play a role in regulating cellular metabolism, growth and proliferation - all crucial factors in cancer development. Using nanotechnology and pH-sensitive polymers, Biodexa has designed eRapa to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. The medication can also potentially be used to treat bladder and prostate cancers. Results of an ongoing phase 2 study into bladder cancer are expected to be announced in the second quarter of 2025. Crucially, the Cancer Prevention Research Institute of Texas (CPRIT) has awarded a $17 million grant to support the phase 3 registrational study of eRapa in FAP. The grant requires a 1 for 2 match and Biodexa recently announced that it secured $7 million, most of the required $8.5 million match, in financing through the exercise of existing warrants, which the company intends to use to advance eRapa through the final clinical stage. A phase 3 trial is expected to start in the first quarter of 2025 which, if successful, is expected to lead to applications for marketing approvals in the U.S. and Europe. eRapa has the potential to catapult Biodexa from a clinical-stage biotech to a commercial organization, supported by non-dilutive grant funding for a devastating disease that currently has no FDA-approved drugs. All eyes are now on the upcoming 12-month results of the phase 2 trial to be announced later this month, and the subsequent phase 3 trial next year.
공고 • May 23Biodexa Pharmaceuticals PLC Announces Positive Statistically Significant Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis (FAP) Scheduled for Presentation at the 2024 Digestive Disease Week Annual MeetingBiodexa Pharmaceuticals PLC announced that results of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis (‘FAP’) (NCT04230499) are scheduled for presentation at the prestigious 2024 Digestive Disease Week annual meeting in Washington D.C. Carol Burke, MD, the Principal Investigator, will present the six month data in a podium presentation at the meeting. The study was partially supported by $20 million in grant funding from the Cancer Prevention and Research Institute of Texas under product development awards DP22053 and DP190069. Design of the Phase 2 study: The open-label study was conducted in seven U.S. centers of excellence in 30 adult patients with median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis and at least 10 adenomas in the rectal remanent (n=24). Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden at six months, as measured by the aggregate of all polyp diameters. Polyp outcomes were classified into Progressive Disease (PD: >20% increase in polyp burden), Stable Disease (SD: ± 20% change in polyp burden) or Partial Response (PR: >20% reduction in polyp burden). A combination endpoint of non-progressors included SD and PR. Results of the Phase 2 study at six months: In the duodenum, 14/18 (78%) patients were non-progressors with 11/18 (61%) of these patients with PR. In the colorectum, 25/29 (86%) patients were non progressors including all with an intact colon; of these 15/29 (67%) patients demonstrated PR including 4 with an intact colon. Only two drug-related Grade 3 Serious Adverse Events occurred during the trial (with no Grade 4 or 5 reported), and 97% of patients remained on treatment at six months.
공고 • May 18Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 13, 2024Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 13, 2024. Location: 1 caspian point, caspian way, cardiff cf10 4dq, United Kingdom
공고 • Mar 29Biodexa Pharmaceuticals Plc's MTX110 Shows Promise In Extending Life Expectancy Against Aggressive Brain CancersBiodexa Pharmaceuticals is developing MTX110 for the treatment of Diffuse Midline Glioma (DMG) in pediatric patients and for Recurrent Glioblastoma (rGBM) in adults; two aggressive brain cancers with universally poor prognoses. The company says early trials of MTX110 in both cancers show promise in extending survival rates beyond those reported in previously published studies. DMG tumors are highly aggressive grade IV tumors that exhibit a propensity to infiltrate the surrounding tissues. Commonly found throughout the brainstem, these tumors pose significant challenges in treatment. The median overall survival rate for individuals - typically children diagnosed with diffuse midline glioma is less than one year - generally ranges from eight to 11 months. A small percentage, approximately 10%, manage to survive for at least two years following diagnosis. Glioblastoma (GBM) is the most prevalent malignant primary tumor of the central nervous system in adult patients and is known for its aggressive nature and tendency to invade surrounding tissues. Although GBM is rare, it carries a high fatality rate, with an incidence of 3.44 per 100,000 individuals and a median overall survival of only eight months, regardless of treatment. The five-year survival rate stands at a mere 7.2%. Recurrence poses a significant challenge for adult patients with GBM, and the prognosis remains bleak. Tumor recurrence, typically occurring within seven months from the initial diagnosis, is the primary cause of mortality. Both cancers have a high mortality rate and a high unmet need. Biodexa is hoping to meet these needs as it further develops MTX110. The main chemotherapy agent of MTX110, panobinostat, was originally used to treat multiple myeloma and received FDA approval in 2015. The company is currently reworking the chemotherapy agent by changing its delivery method and leveraging Convection Enhanced Delivery (CED) technology. Researchers discovered that the original formulation of panobinostat was capable of blocking enzymes involved in cancer cell growth, exhibiting high potency against brain stem tumor cells in vitro and in vivo. However, the original oral tablet form is both insoluble and incapable of crossing the blood-brain barrier at therapeutic levels - making it an ineffective treatment method for brain cancers. The distinctive feature of MTX110 is that it combines a water-soluble form of panobinostat with a CED device that delivers the drug directly to the brain tumor through a surgically implanted catheter and refillable pump. Biodexa says the drug achieves high drug concentrations within the tumor while limiting systemic exposure. The proof-of-concept phase 1 clinical trial of MTX110 took place at the University of California San Francisco with patients battling DMG. The trial produced promising results with a median overall survival of 26 months, compared to a historical overall survival rate of 10 months. Similarly, a phase 1 trial involving newly diagnosed DMG patients at Columbia University Irving Medical Center also had encouraging outcomes, with MTX110 treatment increasing median overall survival to 16 months from a historical overall survival rate of 10 months. The findings from this study will be presented at the 21st International Symposium on Pediatric Neuro-Oncology (June 28 - July 2, 2024), and the company may potentially continue developing the drug in this indication in a phase 2 study. Biodexa reports that the ongoing MAGIC-G1 phase 1 trial in recurrent GBM patients at Duke Cancer Institute and Baptist MD Anderson Cancer Center is currently showing considerable progress with completion of recruitment for cohort A of the study. The first patient survived for 12 months, and three patients currently remain in the study. The expected topline results for progression-free survival from cohort A will be available in Second Quarter of 2024. The retrospective analysis of 299 patients with similar recurrent GBM disease showed a median overall survival of only 6.5 months after the recurrence of GBM cancer. Biodexa is hopeful MTX110 could potentially help extend patient life, offering much-needed hope to patients and their families. The company's delivery method may also help prevent full-body exposure, which could minimize negative side effects. For cancers with such high mortality rates, any amount of extra time with a better quality of life is groundbreaking.
공고 • Feb 24Biodexa Pharmaceuticals plc Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D UpdateBiodexa Pharmaceuticals PLC announced an R&D update including positive top-line clinical trial results of a recently completed Phase 1 study of MTX110 in patients with diffuse midline glioma, or DMG, and results of a preclinical experiment designed to demonstrate tolimidone's potential for beta cell proliferation in an in vitro model. MTX110: In an investigator initiated study conducted by Columbia University Irving Medical Center, patients newly diagnosed with DMG were administered MTX110 via convection enhanced delivery ("CED") using a subcutaneous pump connected to a catheter directly implanted into the pons in a 3+3 dose-escalating design (NCT 04264143). As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary objective of the study was safety and tolerability and, accordingly, the number of infusions was limited to two, each of 48 hours, 7 days apart. Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2). One patient in the 60 M group suffered a severe adverse event assessed by the investigators as not related to the study drug but related to the infusion and tumor anatomy. Although the study was not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months. This compares favourably with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Study investigators are planning to present detailed results of the trial at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) being held on June 28-July 2, 2024 in Philadelphia, PA. On the Company's behalf, a CRO conducted an in vitro experiment designed to demonstrate tolimin's potential for beta cell proliferation using reaggregated pancreatic islets. The results of the experiment were inclusive in that they did not correlate with the results previously seen in vitro and in vivo studies of tolimidone. The Company believes there are a few possible explanations to the outcome of this in vitro study and accordingly, plans to move ahead rapidly with an in vivo preclinical study with similar objectives while continuing preparations for its planned Phase IIa open-label study of tolimidone in patients with Type 1 diabetes due to start recruitment later this year.
공고 • Feb 09Biodexa Pharmaceuticals plc Reports 12 Month Survival in Magic-G1 Study of Mtx110 in Recurrent Glioblastoma PatientsBiodexa Pharmaceuticals PLC provided survival updates from its MAGIC-G1 study (NCT05324501) of MTX110 in patients with recurrent glioblastoma (“rGBM”) being conducted at Duke Cancer Institute and Baptist MD Anderson Cancer Center. In October 2023, Biodexa announced completion of recruitment of Cohort A of an ongoing open-label Phase I dose-escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery via implanted refillable pump and catheter. Because no drug-related adverse events were observed within the first 30 days from start of treatment, the minimum number of four patients were recruited into Cohort A. Patient #1 received weekly infusions of 60µM of MTX110 and survived for 12 months from the start of treatment (OS=12). Patients #2, 3 and 4 each received weekly infusions of 90µM of MTX110, the expected optimum dose, and remain in the study. GBM universally recurs and once it does median overall survival according to a retrospective analysis of 299 patients reported in the Journal of Neuro-Oncology is 6.5 months1. Currently, no standard of care is established for rGBM.
공고 • Dec 29Biodexa Appoints Ann Merchant to the Board of DirectorsBiodexa Pharmaceuticals PLC announced the appointment of Ann Merchant to the Board of Directors of the Company as Non-executive Director with effect from 31 December 2023. Since 2018, Ann Merchant has served as Vice President for MorphoSys, and currently as Head of Global Supply Chain and External Operations. Prior to joining MorphoSys, from September 2011 to August 2018, Ms. Merchant served as the President of Schreiner Medipharm. Between 1994 and 2011, Ms. Merchant held various roles at Amgen in Europe and the US, including Vice President, Head of International Supply Chain and Site Head between 2007 and 2011. Ms. Merchant is also a Non-executive Director of Alvotech S.A. Ms. Merchant is a U.S citizen and holds a Bachelor of Science in Languages from Georgetown University and an MBA from the Henley Business School.
공고 • Dec 21Biodexa Pharmaceuticals Plc has completed a Composite Units Offering in the amount of $5.217389 million.Biodexa Pharmaceuticals Plc has completed a Composite Units Offering in the amount of $5.217389 million. Security Name: Class A Units Security Type: Equity/Derivative Unit Securities Offered: 697,614 Price\Range: $2 Discount Per Security: $0.16 Security Name: Class B Units Security Type: Equity/Derivative Unit Securities Offered: 1,911,176 Price\Range: $1.9999 Discount Per Security: $0.159992
공고 • Oct 05Biodexa Pharmaceuticals plc Completes Recruitment of Cohort A in Study of Mtx110 in Patients with Recurrent GlioblastomaBiodexa Pharmaceuticals PLC announced that it has completed recruitment into cohort A of its ongoing Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in patients with recurrent glioblastoma (rGBM). MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts (A and B), with a minimum of four patients in each; while patients in both cohorts receive MTX110 via intermittent repeated CED infusions, patients in the B cohort will be allowed CED catheter repositioning upon first in-study clinical and/or radiographic confirmed progression. Following review by the Data Safety Monitoring Board (DSMB), the dose was escalated to 90µM after the first patient in cochort A and, because there have been no dose-limiting toxicities, recruitment into this cohort has concluded with the minimum of four patients. Patient 1 received 13 treatment cycles over 19 weeks of study treatment period, whereas patient 2 received 10 cycles over 13 weeks of study treatment period; patient 3 has, to date, received five cycles of treatment. The fourth patient underwent surgery on October 2, 2023 and will receive their first cycle of treatment imminently. Enrolment in cohort B will commence upon approval by the study DSMB, which is anticipated to be received towards the end of October 2023. In addition, the Company is planning to add two more investigational centres into the study with activation expected in December 2023 and January 2024, respectively.
공고 • Sep 22Biodexa to Present Recruitment and Treatment Update in Phase 1 Study of Mtx-110 (Magic-G1 Study) in Patients with Recurrent Glioblastoma At 2023 Annual European Association of Neuro-Oncology Meeting (Eano)Biodexa Pharmaceuticals PLC announced that it will be presenting an update on the recruitment and treatment of patients in the ongoing Phase 1 study of MTX-110 (also known as MAGIC-G1 study) in patients with recurrent glioblastoma (rGB) during a poster session on 22 September 2023, at the 2023 annual EANO meeting in Rotterdam, the Netherlands (NCT 05324501). MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX-110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; while patients in both cohorts will receive MTX-110 via intermittent repeated CED infusions, patients in the second cohort will be allowed CED catheter repositioning upon first in-study clinical and/or radiographic confirmed progression. As of the time of this announcement, three patients have been dosed in the first cohort of the study. No dose-limiting toxicities have been observed at any dose level; and all study-related, non-surgical adverse events were grade 1 or 2 and correlated with the location of the lesion being treated. Patient 1 has received 13 treatment cycles over 19 weeks of study treatment period, whereas patient 2 received 10 cycles over 13 weeks of study treatment period; patient 3 has been recently enrolled and continues to receive treatment. GB is the most common and devastating primary malignant brain tumour in adults encompassing 14.3% of all primary brain and central nervous system neoplasms(1). With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people in the USA will be diagnosed with GB per annum. Standard of care for treatment of GB is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune® device. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality. The median survival from initial diagnosis is less than 21 months(2). Currently, no standard of care is established for rGB. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501), paediatric DMG (NCT04264143) and recurrent medulloblastoma (NCT04315064). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG and GBM tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).
공고 • Jul 25Biodexa Regain Compliance with Nasdaq Minimum Bid Price RequirementBiodexa Pharmaceuticals PLC announced that, on July 20, 2023, it received a notification from The Nasdaq Stock Market LLC (“Nasdaq”) confirming the Company has cured the previously disclosed bid price deficiency, and that the Company is in compliance with all applicable listing standards. The Company’s securities will continue to be listed and traded on Nasdaq and the previously announced hearing with the Nasdaq Hearing Panel is cancelled. Nasdaq further notified the Company that it will be subject to a Mandatory Panel Monitor for a period of one year from July 20, 2023. If, within that one-year monitoring period, the Listing Qualifications Staff finds the Company out of compliance with the rules that was subject to the previous exception, the Staff will issue a delisting determination letter and the Company will have the opportunity to request a hearing with the Nasdaq Hearings Panel.
공고 • Jul 11Biodexa Ltd Announces Completion of Enrolment and Treatment in the Phase 1 Study of Mtx110 in the Treatment of Children with Newly Diagnosed Diffuse Midline Gliomas (Dmgs)Biodexa Ltd. announced completion of enrolment and treatment of nine paediatric patients into the ongoing investigator-sponsored Phase I study of MTX-110 in newly diagnosed DMGs (NCT 04264143). All of the patients (age range 4-17 years) were enrolled at the Columbia University Irving Medical Centre and received radiation therapy as per the institution's standard of care. Each patient subsequently underwent surgery with implantation of an intratumoral catheter and a programmable subcutaneous pump and 8 out of 9 have received two infusions of MTX110 via convection-enhanced delivery (CED) separated by a period of 1 week. concentrations of 30, 60 or 90 uM were delivered with no intra-patient dose escalation. No dose limiting toxicities related to the study drug have been reported in the study. Full study results are expected to be made public around the 1st quarter of 2024. About DMG: DMG is a primary brain tumour arising in the midline structures of the brain including the pons of the brain stem, is diffusely infiltrating and cannot be surgically removed. Occurring mostly in children, the median survival rate in a cohort of 316 cases was 10.0 months and overall survival at 12 months was 35% (Jansen et al, 2015. Neuro-Oncology 17(1):160-166). Although radiotherapy prolongs survival, the majority of patients die within one year following diagnosis. Systemic chemotherapy is ineffective, often due to an inability of agents to cross the blood-brain barrier. Approximately 1,100 (data on file) individuals are diagnosed with DIPG worldwide each year. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-b-cyclodextrin (HPBCD), that enables CED at potentially therapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®?) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501), paediatric DMG (NCT04264143) and recurrent medulloblastoma (NCT04315064). MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG and GBM tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).
공고 • Jul 08Biodexa Pharmaceuticals Announces Results of Appeal of Delisting DeterminationBiodexa Pharmaceuticals PLC announced that, on July 5, 2023, The Nasdaq Stock Market LLC’s (“Nasdaq”)Hearings Panel notified the Company that, in connection with its request for a temporary exception to regain compliance with Nasdaq’s requirement that the closing bid price of its securities remain at $1.00 or higher as required by Nasdaq Listing Rule 5810(c)(3)(A) (the “Minimum Bid Price Rule”), and further to the Company’s recently completed consolidation of its American depositary receipts, which had the effect of a one-for-80 reverse split, it has been granted an exception until July 18, 2023 to demonstrate compliance with the Minimum Bid Price Rule. If the Company’s securities fail to regain compliance with the Minimum Bid Price Rule by that date, Nasdaq will delist the securities.
공고 • Jul 07Biodexa Pharmaceuticals plc Announces the Publication of the Results of an Investigator-Initiated Phase I Study Pnoc015Biodexa Pharmaceuticals PLC announced the publication of the results of an investigator-initiated Phase I study PNOC015 (also known as MTD-201) of MTX110 in the treatment of pediatric patients with DMG (formerly known as Diffuse Intrinsic Pontine Glioma, or DIPG) in the Journal of Neuro-Oncology (NCT 03566199). The study recruited seven pediatric patients with confirmed diagnosis of DMG, after radiation therapy. Convection Enhanced Delivery (CED) of MTX110 at doses escalating from 30uM to 90mM was performed, with a total of 48 infusions across all patients. The study has demonstrated acceptable safety profile of the treatment (three patients reported dose-limiting toxicities) and encouraging efficacy with median overall survival (OS) of 26.1 months comparing favourably with historical data of OS of 10.0 months.
공고 • Jun 21Biodexa Pharmaceuticals Receives a Period of 180 Calendar Days to Return to Compliance with the Minimum Bid Price RuleOn June 20, 2023, Biodexa Pharmaceuticals PLC announced that, on June 16, 2023, it appealed the Staff Determination from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’), to a Hearings Panel (the ‘Panel’) to delist the company’s securities from The Nasdaq Capital Market because the company’s securities have had a closing bid price below $0.10 for ten consecutive trading days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii)(1) (the ‘$0.10 Rule’). In addition to the $0.10 Rule delisting notice, the company also currently fails to satisfy the requirement that the closing bid price of its securities remain at $1.00 or higher as required by Nasdaq Listing Rule 5810(c)(3)(A) (the ‘Minimum Bid Price Rule’). The company has received a period of 180 calendar days to return to compliance with the Minimum Bid Price Rule, which compliance period expires on July 31, 2023. If the company’s securities fail to regain compliance with the Minimum Bid Price Rule, Nasdaq will have an additional basis for delisting the securities. As noted in the Company’s press release on June 15, 2023, the hearing request will stay the suspension of the Company’s securities and the filing of the Form 25-NSE pending the Panel’s decision. In connection with its request for a hearing, the Company has also requested that the Staff Determination be further stayed pending the resolution of the Company’s appeal. Subsequent to the Company’s request for a hearing, Nasdaq notified the Company that the Panel would hear its appeal on August 10, 2023. The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirements under the Nasdaq Listing Rules for continued listing on Nasdaq prior to the hearing.
공고 • Jun 16Biodexa Pharmaceuticals Receives Staff Determination Letter from Nasdaq to Delist its Securities from The Nasdaq Capital Market Regarding Non-Compliance with the Minimum Bid Price RequirementsOn June 15, 2023, Biodexa Pharmaceuticals Plc announced that on June 14, 2023, it received a Staff determination letter (the ‘Letter’) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market because the Company’s securities have had a closing bid price below $0.10 for ten consecutive trading days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii) (the ‘$0.10 Rule’). In addition to the $0.10 Rule delisting notice, the Company also currently fails to satisfy the requirement that the closing bid price of its securities remain at $1.00 or higher as required by Nasdaq Listing Rule 5810(c)(3)(A) (the ‘Minimum Bid Price Rule’). The Company has received a period of 180 calendar days to return to compliance with the Minimum Bid Price Rule, which compliance period expires on July 31, 2023. If the Company’s securities fail to regain compliance with the Minimum Bid Price Rule, Nasdaq will have an additional basis for delisting the securities. Pursuant to the Letter, unless the Company requests an appeal of the Letter, trading of the Company’s American depositary shares (‘ADSs’) will be suspended at the opening of business on June 23, 2023, and a Form 25-NSE will be filed with the Securities and Exchange Commission (the ‘SEC’), which will remove the Company’s securities from listing and registration on the Nasdaq Stock Market. The Company plans to appeal the Staff’s determination to a Hearings Panel (the ‘Panel’). A hearing request will stay the suspension of the Company’s securities and the filing of the Form 25-NSE pending the Panel’s decision. The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the minimum bid price requirements under the Nasdaq Listing Rules for continued listing on Nasdaq.
공고 • Jun 08Biodexa Pharmaceuticals Plc announced that it has received $3.320388 million in fundingOn June 7, 2023, Biodexa Pharmaceuticals Plc closed the transaction. The transaction included participation from 15 investors.
공고 • May 23Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 14, 2023Biodexa Pharmaceuticals Plc, Annual General Meeting, Jun 14, 2023, at 11:00 Coordinated Universal Time. Location: 1 Caspian Point Caspian Way, Cardiff CF10 Wales Greater London United Kingdom
공고 • May 19Biodexa Pharmaceuticals Plc (NasdaqCM:BDRX) entered into non-binding letter of intent to acquire Varian Biopharmaceuticals Inc. for $3.7 million.Biodexa Pharmaceuticals Plc (NasdaqCM:BDRX) entered into non-binding letter of intent to acquire Varian Biopharmaceuticals Inc. for $3.7 million on May 18, 2023. Under the non-binding letter of intent, Varian equity and debt holders will receive 10 million of Biodexa's American Depositary Shares (“ADSs”) at close as initial consideration. Varian Securityholders will receive up to a further 6 million ADSs, issuable in two phases: 3 million upon the commencement of the first pivotal registration study of a Varian product and an additional 3 million upon the first FDA approval of a Varian product. On a pro forma basis, prior to the planned financing, Varian Biopharmaceuticals securityholders will own approximately 34% of the post-acquisition company. The transaction is subject to shareholder approval, and appropriate representations and warranties by the parties.
Reported Earnings • May 01Full year 2022 earnings released: UK£0.077 loss per share (vs UK£1.36 loss in FY 2021)Full year 2022 results: UK£0.077 loss per share. Revenue: UK£699.0k (up 21% from FY 2021). Net loss: UK£7.66m (loss widened 40% from FY 2021).
공고 • Feb 19Midatech Pharma plc announced that it has received $5.999223 million in fundingOn February 17, 2023, Midatech Pharma plc closed the transaction. The transaction included participation from six investors.
공고 • Feb 04Midatech Pharma Announces Receipt of NASDAQ NoticeMidatech Pharma plc announced that it received written notification from The NASDAQ Stock Market LLC, dated 31 January 2023, stating that the Company is not in compliance with the minimum bid price requirement set forth in NASDAQ's rules for continued listing on The NASDAQ Capital Market. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's American Depositary Shares (the "Depositary Shares"), each representing 25 ordinary shares of the Company, for the 30 consecutive business days beginning14 December2022, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing of the Depositary Shares, and they will continue to trade on The NASDAQ Capital Market under the symbol "MTP." In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until 31 July 2023 (the "Compliance Period"), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Depositary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the Compliance Period. If the Depositary Shares do not regain compliance with the minimum bid price requirement during the Compliance Period, the Company may be eligible for an additional grace period of 180 calendar days provided that the Company satisfies NASDAQ's initial listing standards for listing on The NASDAQ Capital Market, other than the minimum bid price requirement, and provides written notice to NASDAQ of its intention to cure the delinquency during the second grace period. If the Company does not regain compliance during the initial grace period and is not eligible for an additional grace period, NASDAQ will provide written notice that the Depositary Shares are subject to delisting from The NASDAQ Capital Market. In that event, the Company may appeal such determination to a hearing panel. The Company intends to monitor the bid price of its Depositary Shares during the Compliance Period and will consider taking such actions as may be necessary and appropriate to achieve compliance with continued listing requirements prior to the expiration of all available grace periods. The Company's business operations are not affected by the receipt of the Notification Letter. The Company's ordinary shares are admitted to trading on the AIM Market of the London Stock Exchange, and the Notification Letter does not affect the Company's compliance status with the AIM Rules for Companies.
공고 • Jan 12Midatech Pharma PLC Announces Planned Dose Escalation in MTX-110 Phase 1 StudyMidatech Pharma PLC announced that following completion of one month of treatment with MTX-110 in the first patient, its Phase I study of MTX-110 in recurrent glioblastoma (rGB) (NCT 05324501) will continue with a planned dose escalation following a positive recommendation from the study's Data Safety Monitoring Board (DSMB). The Phase I study, the MAGIC-G1 study, is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX-110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort will receive MTX-110 only and the second cohort will receive MTX-110 in combination with lomustine. The first patient in the study was dosed at 60uM of MTX-110 via direct-to-tumour delivery and has received four 48-hour infusions over a period of four weeks. No treatment-associated adverse events were noted in the patient during this period. Following successful completion of the first month of treatment, the DSMB reviewed the available data on 11 January 2023 and recommended dose escalation in the study to 90uM. This dose is expected to be the optimal one of MTX-110 and is the one currently being used in the ongoing Phase I study of patients with diffuse intrinsic pontine glioma (DIPG) at the Columbia University, USA. Patient 1 continues treatment as per the study protocol and patient 2 is expected to start treatment by the end of January 2023 and will receive the 90uM dose. GB is the most common and devastating primary malignant brain tumour in adults encompassing 14.3% of all primary brain and central nervous system neoplasms. With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people in the USA will be diagnosed with GB per annum. Standard of care for treatment of GB is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune® device. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality. The median survival from initial diagnosis is less than 21 months. Currently, no standard of care is established for rGB. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favorable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient derived DIPG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).
공고 • Dec 15Midatech Pharma plc announced that it expects to receive $9.6 million in fundingMidatech Pharma plc announced a private placement of common shares for gross proceeds of $9,600,000 on December 13, 2022. The transaction is expected to close in the first quarter of 2023 with acquisition of Bioasis Technologies Inc. The transaction is subject to approval from the shareholders of the company. The transaction has been approved by the board of directors of Bioasis Technologies Inc.
공고 • Nov 14Midatech Pharma plc Announces First Patient Enrolled in Phase 1 Study of MTX-110Midatech Pharma PLC announced the enrolment of the first patient into its Phase 1 study of MTX110 in recurrent glioblastoma (rGB) (NCT 05324501) at the Preston Robert Tisch Brain Tumor Center at Duke University, USA. The Phase I study is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort will receive MTX110 only and the second cohort will receive MTX110 in combination with lomustine. Midatech has previously reported encouraging results from a Phase I study of MTX110 in diffuse intrinsic pontine glioma conducted by University of California, San Francisco with an additional Phase I study of MTX110 in DIPG conducted by Columbia University expected to report shortly. In addition, a Phase I study of MTX110 in medulloblastoma is being undertaken at the University of Texas. MTX110 has been granted Orphan Drug and Fast Track designations by the FDA and Orphan Medicinal Product designation by EMA.
공고 • Oct 19Midatech Pharma plc Announces Receipt of Nasdaq NotificationMidatech Pharma plc announced that further to the Company's announcement on April 14, 2022, it has received written notification dated October 10, 2022 (the "Notification Letter") from The NASDAQ Stock Market LLC ("NASDAQ") that for 10 consecutive business days, from September 26, 2022 to October 9, 2022, the closing bid price of the Company's American Depositary Shares had been at $1.00 per share or greater and, accordingly, the Company has regained compliance with NASDAQ Listing Rule 5550(a)(2).
공고 • Jun 21Midatech Pharma PLC Announces Directorate ChangeMidatech Pharma PLC announced the appointment of Dr. Stephen Barry Parker as a Director of the Company and Non-Executive Chairman of the Board with immediate effect. Stephen Parker has over 30 years' experience in leadership roles both in the healthcare industry and in advisory roles. Currently, he is Chairman of Sareum Holdings plc and Drishti Discoveries Ltd., a Non-Executive Director of MGC Pharmaceuticals Ltd. and an Executive Director of sp2 Consulting Limited. Previously, Stephen held a number of executive and board positions at various public and private biotech companies and senior roles at leading investment banks. Stephen has an MBA from City University and a D.Phil. in biochemistry from Oxford University. Dr. Parker is taking over from Rolf Stahel, who has resigned as a Director of the Company and stepped down as Chairman in line with his proposed retirement, previously announced on 10 June 2022. Dr. Stephen Barry Parker, aged 63: Current Directorships and Partnerships - Sareum Holdings Plc, Sareum Limited, sp2 Consulting Limited, sp2 Asset Management Ltd, MGC Pharmaceuticals Limited, Drishti Discoveries Ltd. and Eternans Ltd. Previous Directorships and Partnerships (past 5 years) - Silence Therapeutics Plc, Liverpool Chirochem Limited and Albucasis Limited. Dr. Parker was formerly a director of Celtic Pharma Development UK Plc, Xenova Group Limited and Xenova Limited, each of which were subsidiaries of Celtic Pharma GP Limited and were placed into creditors voluntary liquidation in April 2014. As of the date of this announcement, Dr. Parker holds no ordinary shares or options in the Company.
공고 • Jun 11Midatech Pharma plc Announces MTX110 Study to be Presented at ISPNO 2022Midatech Pharma PLC announced that investigators from Columbia University Irving Medical Center and New York-Presbyterian will present interim results from their ongoing Phase 1 study on Midatech's MTX110 in Diffuse Intrinsic Pontine Glioma ("DIPG") at The International Symposium on Pediatric Neuro-Oncology ("ISPNO 2022") that will take place on 12-15 June 2022 in Hamburg, Germany. The presentation is titled: "A Phase I study examining the feasibility of intermittent convection-enhanced delivery (CED) of MTX110 for the treatment of children with newly diagnosed diffuse midline gliomas." The presentation will take place on 13 June 2022 in the neurosurgery section of the conference, at 10.30 am CEST. The investigators will show first data on seven out of the ten planned patients on the safety of MTX110 (a water-soluble formulation of panobinostat) in patients with DIPG. This study uses an implantable pump and catheter system that allows for continuous intratumoral administration of the study drug without the need for repeated surgery. The study continues its recruitment. MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-ß-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for DIPG (NCT03566199, NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of glioblastoma (SNO 2020 Abstract TMOD-27). MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG cell lines.
공고 • Jun 10Midatech Pharma plc Announces Retirement of Rolf StahelMidatech Pharma PLC announced that Rolf Stahel, Chairman and non-executive director, intends to retire after the Company's Annual General Meeting on 20 June 2022 It is expected that Dr. Stephen Parker will be appointed as non-executive Chairman of the Board, following the AGM. Stephen Parker has over 30 years' experience in leadership roles both in the healthcare industry and in advisory roles. Currently, he is Chairman of Sareum Holdings plc and Drishti Discoveries Ltd, a Non-Executive Director of MGC Pharmaceuticals Ltd. and an Executive Director of sp2 Consulting Limited. Previously, Stephen held a number of executive and board positions at various public and private biotech companies and senior roles at leading investment banks. Stephen has an MBA from City University and a D.Phil. in biochemistry from Oxford University.
공고 • Jun 02Midatech Pharma plc Announces Fast Track Designation Granted to Mtx110 Development for the Treatment of Recurrent GlioblastomaMidatech Pharma plc announced that upon submitting an application to the U.S. Food and Drug Administration FDA, its development programme of MTX110 for the treatment of recurrent glioblastoma has been granted Fast Track designation by the agency. Fast Track is a process designed to facilitate the development and expedite the review of treatments for serious conditions and that potentially address unmet medical needs. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.
공고 • May 25Midatech Pharma plc, Annual General Meeting, Jun 20, 2022Midatech Pharma plc, Annual General Meeting, Jun 20, 2022, at 13:00 Coordinated Universal Time. Location: 1 Caspian Point, Caspian Way, Cardiff CF10 4DQ Cardiff United Kingdom
공고 • Apr 15Midatech Pharma Received Written Notification from Nasdaq Stating Company Is Not in Compliance with Minimum Bid Price RequirementMidatech Pharma plc announces that it received written notification (the "Notification Letter") from The NASDAQ Stock Market LLC ("NASDAQ"), dated 13 April 2022, stating that the Company is not in compliance with the minimum bid price requirement set forth in NASDAQ's rules for continued listing on The NASDAQ Capital Market. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company's American Depositary Shares (the "Depositary Shares"), each representing five ordinary shares of the Company, for the 30 consecutive business days beginning 2 March 2022, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing of the Depositary Shares, and they will continue to trade on The NASDAQ Capital Market under the symbol "MTP". In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until 10 October 2022 (the "Compliance Period"), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Depositary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the Compliance Period. If the Depositary Shares do not regain compliance with the minimum bid price requirement during the Compliance Period, the Company may be eligible for an additional grace period of 180 calendar days provided that the Company satisfies NASDAQ's initial listing standards for listing on The NASDAQ Capital Market, other than the minimum bid price requirement, and provides written notice to NASDAQ of its intention to cure the delinquency during the second grace period. If the Company does not regain compliance during the initial grace period and is not eligible for an additional grace period, NASDAQ will provide written notice that the Depositary Shares are subject to delisting from The NASDAQ Capital Market. In that event, the Company may appeal such determination to a hearing panel. The Company intends to monitor the bid price of its Depositary Shares during the Compliance Period and will consider taking such actions as may be necessary and appropriate to achieve compliance with continued listing requirements prior to the expiration of all available grace periods. The Company's business operations are not affected by the receipt of the Notification Letter.
공고 • Dec 14Midatech Pharma PLC Announces Investigational New Drug Application for Study of MTX110 in Recurrent Glioblastoma (GBM) Becomes EffectiveMidatech Pharma PLC announced that its Investigational New Drug (IND) application for a Phase 1 study of MTX110, a panobinostat complex to be administered by convection enhanced delivery in patients with recurrent glioblastoma multiforme (rGBM), has been cleared by the US FDA. Accordingly, Midatech has initiated preparations for a study start in the first half of 2022. Employing the Company's MidaSolve™ technology, MTX110 solubilises panobinostat, a histone deacetylase (HDAC) inhibitor currently used in the treatment of multiple myeloma. In a liquid formulation as MTX110, panobinostat can be delivered directly to a patient's tumour under constant pressure via a catheter system (Convection Enhanced Delivery, or "CED") thereby bypassing the blood-brain barrier and allowing for high drug concentrations and broader drug distribution in and around the tumour while simultaneously minimising systemic toxicity and other side effects. Panobinostat has demonstrated high potency against patient-derived tumour cells in vitro and in vivo models. GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumours recur. There are approximately 2-3/100,000(1) diagnoses of GBM per annum. Survival with standard of care treatment ranges from approximately 13 months in unmethylated MGMT patients to approximately 30 months in highly methylated MGMT patients(2). Glioblastoma is an intractable brain cancer. The primary objective of the Phase I study will be to assess the safety and tolerability of MTX110 in patients with rGBM. The study is expected to include two clinical centres in the US and to begin recruiting H1 2022.
공고 • Jun 30Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £10 million.Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £10 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 35,087,720 Price\Range: £0.285 Transaction Features: Regulation S; Subsequent Direct Listing
공고 • Jun 18+ 1 more updateMidatech Pharma plc Announces Shut Down of its Bilbao OperationsMidatech Pharma plc announced breakthrough in vitro data which demonstrate Q-Sphera's potential to formulate proteins into long-acting injectable products, as well as significant progress across multiple other programmes. In the 13 months since the announcement of a Strategic Review, the Company has shut down its Bilbao operations, thereby halving its monthly cash burn rate and pivoted from a largely singular focus on one Phase III ready asset (MTD201, Q-Sphera octreotide) to "multiple shots on goal" with an expanded pipeline of nine earlier stage programmes. The Company's strategy is to develop each programme to proof of concept before seeking Licensing partners to undertake later stage development, manufacturing and commercialisation.
공고 • Dec 13Midatech Pharma PLC to Present MTX110 Programmes at The International Symposium on Pediatric Neuro-Oncology, Karuizawa, JapanMidatech Pharma PLC announced that its University collaborators will be presenting three sets of research findings on MTX110 at The International Symposium on Pediatric Neuro-Oncology on 13-16 December 2020 in Karuizawa, Japan (to be held online this year). The first two presentations, by Columbia University Medical Center and University of Texas Health Center at Houston, are being presented for the first time. The third presentation, by the Pacific Pediatric Neuro-Oncology Consortium, was also presented at last months' Society of Neuro-Oncology (SNO2020) conference. Abstract details and links to the posters are provided below: A Phase I Study Examining the Feasibility of Intermittent Convection-Enhanced Delivery (CED) of MTX110 for the Treatment of Children with Newly Diagnosed Diffuse Intrinsic Midline Gliomas (ABSTRACT DDEL-07, Page iii284) - Lead Author: Dr Stergios Zacharoulis MD, Columbia University Medical Center, New York, USA. In the study: Patients are receiving continuous CED infusions of MTX110 for 48 hours on two cycles separated by 5 to 7 days; 3 patients have been treated so far at 30 microM; No Serious Adverse Events; Toxicity: Grade II diplopia (1) Grade I sensation (n=1), headache Grade II (n=2); and 1 patient progressed 8 months post treatment. High Dose MTX110 (Soluble Panobinostat) Safely Administered into the Fourth Ventricle in a Non-Human Primate Model (ABSTRACT DDEL-09, Page iii285) - Lead Author: Dr David Sandberg MD, McGovern Medical School, University of Texas Health Center at Houston, Houston, Texas, USA. Conclusions of the presentation are: Fourth ventricle catheters were successfully instilled to enable locoregional infusion of MTX110; MTX110 was well-tolerated, with no evidence of toxicity; Drug levels in the CNS reached a therapeutic range; and The data support the safety of administration of MTX110 via the fourth ventricle; and Clinical trial in recurrent medulloblastoma patients is ongoing. PNOC015: An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection-Enhanced Delivery (CED) in Patients with Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated with External Beam Radiation Therapy (ABSTRACT EPCT-12, Page iii306).
공고 • Oct 20Midatech Pharma plc Announces Headline Results of MTX110 Phase I DIPG StudyMidatech Pharma PLC, announced encouraging headline results from a Phase I study at the University of California, San Francisco in patients with Diffuse Intrinsic Pontine Glioma. The primary endpoint of the study was to determine the dosage regimen to be used in a proposed Phase II study of the safety and efficacy of MTX110 in patients with DIPG. Preliminary high-level data from the UCSF study supports a dose of between 60µM and 90µM of MTX110, depending upon patient tolerance over the course of 12 infusions in Phase II. total, seven patients were recruited into the UCSF study. Patients were newly diagnosed with DIPG and received focal external beam radiation therapy four to 14 weeks before commencement of MTX110 treatment. Eligibility required a pontine location of the tumour with diffuse involvement of at least two thirds of the pons and no evidence of metastatic disease. Patients were not excluded by total tumour volume. MTX110 was administered directly into the tumour via a micro-catheter using convection enhanced delivery ("CED") with gadolinium-enhanced intra-operative MRI to guide and track drug distribution to the tumour. Patients could receive up to 12 cycles of treatment every four to eight weeks. The dose was escalated between and within patients as tolerated initially by increasing the infusion volume at a concentration of 30µM MTX110 and then with higher drug concentrations of 60µM and 90µM as the sixth and seventh dose increments, respectively. At the interim cut-off date (30 September 2020), median overall survival based on Kaplan Meier analysis was 26.06 months (CI 11.3 - 26.06 months) and overall survival at 12 months (OS12) was 71.4% (five of seven patients alive). Three patients remain alive and continue to be monitored. Survival was not an endpoint of the UCSF study nor was the study powered for statistical significance and therefore no conclusions as to the impact of MTX110 on overall survival rates can be drawn from these data. The proposed Phase II trial is expected to evaluate overall survival at 12 months as the primary endpoint in 19 evaluable patients. The planned design is single arm and statistically powered for comparisons with defined historical survival data. MTX110 is expected to be delivered using an alternative CED catheter system that enables regular drug infusions directly into the tumour without a need for repeated surgery.
공고 • Aug 28Midatech Pharma plc to Report First Half, 2020 Results on Sep 10, 2020Midatech Pharma plc announced that they will report first half, 2020 results on Sep 10, 2020
공고 • Jul 31Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £5 million.Midatech Pharma plc has completed a Follow-on Equity Offering in the amount of £5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 18,518,518 Price\Range: £0.27 Transaction Features: Subsequent Direct Listing