Announcement • Jul 14
Can-Fite Biopharma Secures Australian Patent Allowance Supporting Namodenoson Development and Marketing in Liver and Pancreatic Cancer Can-Fite BioPharma Ltd. announced that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer." The patent complements Can-Fite's rapidly advancing oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the Company recently completed a Phase 2a clinical study demonstrating an excellent safety profile together with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine. Namodenoson selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and cancer cells. Activation of A3AR has been shown to induce apoptosis of tumor cells while sparing normal tissues, contributing to the compound's favorable safety profile demonstrated across clinical studies. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and enroll patients for a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety of the drug. Namodenoson is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • Jul 06
Can-Fite Biopharma Completes Patient Enrollment for Interim Analysis in Pivotal Phase 3 Psoriasis Study Can-Fite BioPharma Ltd. announced completion of enrolment of the first 247 patients in its pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis. The study has now reached the pre-specified interim analysis stage under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis will evaluate efficacy and safety data from the enrolled patients. Results are expected during Fourth Quarter 2026/First Quarter 2027. The study is a randomized, double-blind, placebo-controlled Phase 3 trial aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. Patients are treated with 3 mg Piclidenoson tablets or placebo administered orally twice daily. The co-primary efficacy objectives of this study are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of 75% or greater (PASI 75) and the proportion of subjects who achieve a Static Physician's Global Assessment (sPGA) at of 0 or 1 at Week 16. Piclidenoson is a first-in-class oral A3 adenosine receptor (A3AR) agonist with a differentiated mechanism of action targeting key inflammatory pathways implicated in psoriasis. Unlike injectable biologic therapies, Piclidenoson is administered orally as a tablet and has demonstrated a favourable safety profile in more than 1,500 subjects treated across clinical studies, supporting its potential use as a chronic long-term treatment. The global psoriasis therapeutics market continues to expand, driven by increasing disease prevalence and demand for safe, effective, and convenient long-term treatment options. Piclidenoson is an orally bioavailable, highly selective A3 adenosine receptor agonist with anti-inflammatory activity demonstrated in both preclinical and clinical studies. The drug has accumulated an extensive clinical safety database involving more than 1,500 subjects and is being developed as a potential chronic therapy for psoriasis and other inflammatory diseases. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. Announcement • Jul 02
Can-Fite Phase 2a Pancreatic Cancer Study with Namodenoson Achieves Primary Safety Endpoint and Demonstrates Durable Survival Outcomes in Advanced Disease Can-Fite BioPharma Ltd. announced that its Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes. The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated, with a safety profile consistent with prior clinical trials. Following extended follow-up, an updated survival analysis was performed in the third-line population, focusing on the eight patients who survived at least two months after treatment initiation, thereby excluding patients with rapidly progressive disease unlikely to derive benefit from systemic therapy. Among the eight evaluable third-line patients: Median overall survival exceeded 5 months; 62.5% of patients survived five months or longer; 37.5% survived seven months or longer; Two patients remain alive at the data cutoff, including one patient continuing treatment and another followed for almost nine months; Durable disease control was observed, including progression-free survival extending beyond seven months. The findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy, supporting further clinical development of Namodenoson. Among the five patients treated in the second-line setting, one patient remains alive more than 18 months after initiation of Namodenoson therapy, representing the longest survivor in the study. Can-Fite BioPharma plans to advance Namodenoson into a Phase 2b combination study with chemotherapy. The decision follows recently published peer-reviewed preclinical data demonstrating that Namodenoson (2-Cl-IB-MECA) enhances the anti-tumor activity of chemotherapeutic agents in pancreatic cancer models by simultaneously inhibiting multiple tumor proliferation and drug-resistance pathways, including Wnt/ß-catenin and Hedgehog signalling, while reducing expression of multidrug-resistance proteins. The publication further demonstrated that Namodenoson increased chemosensitivity in pancreatic cancer cells, providing a strong mechanistic rationale for combination therapy. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and is enrolling patients in a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug. Announcement • Jun 26
Can-Fite Biopharma Secures Japanese Patent Allowance for Namodenoson's Anti-Obesity Technology Can-Fite BioPharma announced that the Japan Patent Office has allowed Japanese Patent Application No. 2025-049941, a divisional application of JP 2023-078136, titled "An A3 Adenosine Receptor Ligand for Use for Achieving a Fat Loss Effect." The allowed patent covers the use of A3 adenosine receptor (A3AR) agonists, including the Company's lead drug candidate Namodenoson, for inducing fat loss and treating obesity and related metabolic disorders. The Japanese patent allowance represents another significant milestone in Can-Fite's expanding global intellectual property portfolio covering Namodenoson's anti-obesity activity. The Company has already secured patent protection for this technology in major jurisdictions including the United States, Canada, Australia and Israel, further strengthening its worldwide exclusivity strategy for this promising therapeutic indication. The growing patent estate is supported by scientific evidence recently published in the peer-reviewed International Journal of Obesity, demonstrating Namodenoson's anti-obesity activity and providing independent scientific validation for its novel mechanism of action. The global obesity therapeutics market continues to experience rapid expansion, driven by increasing disease prevalence and the commercial success of GLP-1 receptor agonists. Despite this growth, currently available therapies are frequently associated with gastrointestinal side effects, injectable administration, treatment discontinuation, and high cost. Namodenoson, an orally administered, highly selective A3 adenosine receptor agonist with an established safety profile from clinical studies, offers a differentiated mechanism of action by targeting key pathways involved in adipogenesis, inflammation, and metabolic regulation. Preclinical and clinical findings suggest its potential to reduce fat accumulation while improving metabolic parameters, positioning it as a promising candidate for future obesity therapy. According to industry forecasts, the global obesity therapeutics market is expected to exceed $60 billion by 2030, driven by increasing obesity prevalence and demand for safe, effective, and convenient oral therapies. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and enrol patients for a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • Jun 22
Can-Fite Biopharma Publishes Peer-Reviewed Scientific Article Demonstrating Broad Therapeutic Potential of Piclidenoson and Namodenoson Can-Fite BioPharma Ltd. issued a press release entitled "Can-Fite Publishes Peer-Reviewed Scientific Article Demonstrating the Broad Therapeutic Potential of Piclidenoson and Namodenoson". The article, entitled "Adenosine A3 Receptor Agonists as Multisystemic Disease Modifiers: From Molecular Signaling to Clinical Translation" was published in the peer-reviewed Biomolecules Journal. The publication reviews findings from Can-Fite work and numerous independent academic and clinical research groups worldwide demonstrating that activation of the A3 adenosine receptor (A3AR) modulates key pathological pathways involved in: Solid tumors, including hepatocellular carcinoma and pancreatic cancer; Metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis; Autoimmune and inflammatory diseases; Osteoarthritis and musculoskeletal disorders; Neurodegenerative diseases, including Alzheimer's disease and vascular dementia; Obesity and metabolic disorders; Rare genetic diseases, including Lowe syndrome. The review details evidence supporting A3AR agonist activity in these indications. Can-Fite's clinical pipeline currently includes Namodenoson in Phase 3 development for hepatocellular carcinoma, Phase 2 development for pancreatic cancer, and Phase 2b development for MASH. Piclidenoson is currently being evaluated in a pivotal Phase 3 study in psoriasis. The publication further supports the Company's strategy of leveraging A3AR agonists as a platform technology applicable to multiple therapeutic indications. Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Namodenoson is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • Jun 03
Can-Fite Biopharma Highlights Namodenoson’s RAS Pathway Inhibition and Reports Positive Clinical Observation in Phase 2A Pancreatic Cancer Study Can-Fite BioPharma Ltd. highlighted the differentiated mechanism of action of namodenoson in pancreatic cancer, including inhibition of the RAS signaling pathway, alongside encouraging clinical observations from its ongoing Phase 2a pancreatic cancer study. Recent presentations and publications emerging from the 2026 American Society of Clinical Oncology meeting have reinforced the importance of targeting RAS-driven malignancies, particularly pancreatic ductal adenocarcinoma (PDAC), where KRAS mutations and downstream RAS activation are central drivers of tumor growth and therapeutic resistance. Can-Fite previously reported preclinical findings demonstrating that namodenoson exerts potent anti-tumor activity in pancreatic cancer through a multi-pathway mechanism involving deregulation of the RAS, Wnt/ß-catenin, and NF-?B signaling pathways, leading to apoptosis and marked inhibition of tumor growth. The Company also reported encouraging clinical observations from its Phase 2a study of namodenoson as a monotherapy in pancreatic cancer. Enrollment has been completed and several patients have demonstrated prolonged disease control, including one patient who has remained on therapy and follow-up for approximately 16 months. Pancreatic cancer remains among the most lethal malignancies, with limited treatment options and poor long-term survival. Approximately 90% of pancreatic cancers are associated with KRAS pathway activation, highlighting the importance of therapies capable of modulating this signaling network. Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of pancreatic cancer. Namodenoson is being evaluated in a Phase III trial for hepatocellular carcinoma, a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • May 20
Can-Fite Biopharma Announces Publication of Positive Findings for Piclidenoson in Canine Osteoarthritis Can-Fite BioPharma Ltd. announced publication of a peer-reviewed scientific article regarding previously reported positive findings from a study evaluating Piclidenoson for the treatment of canine osteoarthritis. The article abstract, titled “Piclidenoson, an A3 Adenosine Receptor Agonist, Improves Clinical Signs in Dogs with Osteoarthritis” was published in the peer-reviewed journal Frontiers in Veterinary Science and is available online. The study described in the publication demonstrated that oral treatment with Piclidenoson resulted in statistically significant improvement in mobility and pain assessments in dogs suffering from osteoarthritis, while maintaining a favorable safety profile. The study supports the continued development of Piclidenoson as a potential oral disease-modifying therapy for canine osteoarthritis. Key findings reported in the publication include: Significant improvement in Liverpool Osteoarthritis in Dogs (LOAD) scores in dogs treated with Piclidenoson at 500 µg/kg BID; Significant reduction in pain scores measured by the Visual Analog Scale (VAS); Significant reduction in veterinarian-assessed lameness and pain; Favorable safety profile with no serious treatment-related adverse events reported; Data supporting Piclidenoson’s potential as a novel oral therapy for canine osteoarthritis. Piclidenoson is being developed for veterinary indications by Vetbiolix under a licensing agreement with Can-Fite potentially valued at up to USD 325 million in upfront, milestone, and royalty payments. Vetbiolix is currently conducting an advanced Phase 2 clinical study evaluating Piclidenoson in dogs with osteoarthritis. Canine osteoarthritis is one of the most common chronic diseases affecting dogs worldwide and represents a significant and growing veterinary market. Current treatment options are limited and are often associated with safety and tolerability concerns during long-term use. Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. Announcement • May 14
Can-Fite BioPharma Ltd Advances Namodenoson Into Phase 2b Combination Study With Immunotherapy Can-Fite BioPharma Ltd. announced plans to advance its pancreatic cancer program into a Phase 2b study evaluating Namodenoson in combination with immunotherapy in patients with advanced pancreatic cancer. The planned Phase 2b study follows encouraging findings from the Company’s ongoing Phase 2a study evaluating Namodenoson in patients with advanced pancreatic adenocarcinoma who progressed following at least one prior line of therapy. The Phase 2a study demonstrated a favorable safety profile together with clinical activity manifested by prolonged treatment duration in a subset of patients including treatment extending beyond 16 months, stable disease observed in >30% of evaluable patients and 35% of patients remain on therapy and follow up. The upcoming Phase 2b study is expected to evaluate Namodenoson in combination with immunotherapy in order to further assess clinical benefit, including progression-free survival, overall survival, disease stabilization, and additional efficacy endpoints. The Company further announced that details of the planned Phase 2b study design are expected to be discussed during the upcoming BIO International Convention in San Diego, where Dr. Sari Fishman, VP Business Development of Can-Fite, is scheduled to meet with oncology companies. Can-Fite has already entered into confidentiality agreements with pharmaceutical companies that are evaluating potential partnership opportunities related to the pancreatic cancer program. Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Announcement • May 03
Can-Fite Biopharma Ltd. Reports Positive Phase 2A Data with Namodenoson in Pancreatic Cancer Can-Fite BioPharma Ltd. announced positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer. The data from the fully enrolled study demonstrate preliminary evidence of clinical activity, including durable disease stabilization in a heavily pretreated patient population, in addition to the previously reported favorable safety profile. Key findings include: Stable disease observed in >30% of evaluable patients. Prolonged treatment duration includes one patient extending beyond 16 months. 35% of patients remain on therapy and follow up. Favorable safety and tolerability profile consistent with prior reports. The prolonged treatment duration observed in several patients suggests a potential for durable clinical benefit in this difficult-to-treat population. As a substantial proportion of patients remain on treatment, full efficacy analyses, including progression-free survival and overall survival, top-line results are expected in the coming months and will be presented in a forthcoming clinical conference. Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The Phase 2a study of namodenoson is an open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of namodenoson in this population. All patients receive oral namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. 20 evaluable patients were enrolled to the study. The primary objective of this trial is to characterize the safety profile of namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases. Announcement • Apr 24
Can-Fite BioPharma Ltd., Annual General Meeting, May 28, 2026 Can-Fite BioPharma Ltd., Annual General Meeting, May 28, 2026. Location: 26 ben gurion street,5257346, ramat gan Israel Announcement • Mar 05
Can-Fite’s Namodenoson Successfully Meets Primary Endpoint in Phase 2a Pancreatic Cancer Study Can-Fite BioPharma Ltd. announced results from its Phase IIa open-label study evaluating namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who had progressed following prior systemic therapies. The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases. The study enrolled 20 patients with advanced PDAC who had received one or more prior lines of therapy. Patients
represented a high-risk population, including individuals with varying performance status and advanced metastatic disease. Secondary endpoints included overall survival (OS) and progression-free survival (PFS). Survival follow-up ongoing, with 1/3 of patients currently alive at the time of data cut-off. As follow-up continues, survival outcomes are expected to further mature and will be announced during upcoming scientific meetings. Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Announcement • Feb 17
Can-Fite Announces Scientific Breakthrough Publication Demonstrating Anti-Obesity Effect of Namodenoson Can-Fite BioPharma Ltd. announced the publication of a peer-reviewed study in the International Journal of Obesity demonstrating the anti-obesity effect of namodenoson, the Company's lead drug candidate. The article, titled "The anti-obesity effect of Namodenoson, an A3 adenosine receptor agonist," is now available online as an Open Access publication. The study evaluated the effects of namodenoson in adipocytes (3T3-L1 fat cells) in vitro and in a murine high-fat diet model of obesity. The findings are consistent with previously reported data from a Phase IIa clinical study in patients with metabolic dysfunction-associated steatohepatitis (MASH), in which treatment with namodenoson for three months was associated with reductions in liver fat and body weight. A Phase IIb MASH study is currently enrolling patients and is designed to evaluate effects on inflammation, fibrosis, steatosis, and body weight. Treatment upregulated adiponectin, a hormone associated with improved metabolic regulation, and supplied PI3K, NF-kB, Akt, and Wnt/b-catenin signaling pathways, suggesting a multi-pathway metabolic mechanism. Namodenoson is currently in advanced clinical development for MASH. The newly published findings expand its potential therapeutic profile into obesity -- a rapidly growing global market with substantial unmet need. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Feb 06
Can-Fite Biopharma Ltd. Announces Patient with Decompensated Liver Cirrhosis Successfully Undergoes Liver Transplantation Following Treatment with Namodenoson Can-Fite BioPharma Ltd. announced that a patient with advanced decompensated liver cirrhosis who was treated with Namodenoson subsequently underwent a successful liver transplantation. The patient received Namodenoson treatment under a compassionate use framework while suffering from liver disease and complications consistent with decompensated cirrhosis. Throughout the treatment period, Namodenoson contributed to clinical stabilization, allowing the patient to remain a suitable candidate for liver transplantation until a compatible donor organ became available, ultimately resulting in a successful, life-saving liver transplantation. The Company's lead drug candidate, Piclidenoson reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • Jan 20
Can-Fite Biopharma Ltd. Completes Patient Enrollment in Phase 2A Pancreatic Cancer Study of Namodenoson Can-Fite BioPharma Ltd. announced that patient enrollment has been completed in its Phase 2a pancreatic cancer clinical trial of Namodenoson. The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel. Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Namodenoson is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (Namodenoson), is being evaluated in a Phase 3 trial for hepatocellular cancer (Namodenoson). Announcement • Jan 19
Can-Fite Biopharma Ltd. Announces Resignation of Yaacov Goldman as Board Member, Effective from January 14, 2026 Can-Fite BioPharma Ltd. On January 14, 2026, Yaacov Goldman, a member of the Board of Directors of Can-Fite BioPharma Ltd., notified the company of his resignation from the Board and all committees thereof on which he served, effective from January 14, 2026. Mr. Goldman resigned from the Board for personal reasons. Announcement • Dec 17
Can-Fite BioPharma Ltd. Provides Update on Clinical and Financial Status Can-Fite BioPharma Ltd. announced an update on its clinical development activities and financial status. Namodenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function. This patient population represents a significant unmet medical need, as no approved therapies are currently available. An interim analysis from the Phase III study is expected to be in approximately fourth quarter of 2026. Subject to positive interim results, the Company may be eligible to seek conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In parallel, Can-Fite is enrolling patients in a Phase IIb clinical study of Namodenoson for thetreatment of metabolic dysfunction-associated steatohepatitis (MASH). This study follows positive results from a completed Phase IIa trial, which demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature. In addition, Namodenoson is being evaluated in a Phase IIa clinical study in patients with pancreatic cancer who have failed first-line treatment. Patient enrollment in this study is nearing completion, and the Company expects to report data during the second quarter of 2026. Piclidenoson drug candidate: Can- Fite is currently enrolling patients In a pivotal Phase III clinical study for the treatment of psoriasis. In this study, patients receive Piclidenoson orally, administered twice daily. The primary efficacy endpoints of the trial are PASI 75 (Psoriasis Area and Severity Index) and Physician's Global Assessment (PGA), consistent with regulatory guidance for late-stage psoriasis studies. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma ("HCC"), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements include, among other things, the history of losses and needs for additional capital to fund operations and inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of preclinical studies, clinical trials and other product candidate development efforts; ability to advance product candidates into clinical trials or clinical trials; receipt of regulatory approvals for product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of product candidates; ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of business model and strategic plans for business and product candidates; the scope of protection the company are able to establish and maintain for intellectual property rights covering product candidates and ability to operate business without infringing the intellectual property rights of others; competitive companies, technologies and industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Israel and Israel and Israel on its business. More information, and statements as to the impact of the political and security situation in Israel on business. Announcement • Nov 20
Can-Fite's Cf602 Erectile Dysfunction Treatment Receives Notice of Patent Allowance in Brazil Can-Fite BioPharma Ltd. announced it received a Notice of Allowance from the National Institute of Industrial Property of Brazil for its patent application titled "An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction". The Company's lead drug candidate, Piclidenoson reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. Announcement • Nov 19
Can-Fite BioPharma Ltd. Announces 9-Year Survival with Complete Cure in an Advanced Liver Cancer Patient Treated with Namodenoson Can-Fite BioPharma Ltd. announced that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete response to treatment. The patient, who suffered from advanced liver cancer, was enrolled in Can-Fite's completed Phase II study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappear of amites, normal liver function, and good quality of life. Can-Fite is currently enrolling patients in Israel, Europe, and the U.S. for a pivotal Phase III clinical study of Namodenoson for patients with advanced hepatocellular carcinoma (HCC), the common form of liver cancer, as a 2nd or 3rd line treatment. The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma ("HCC"), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food & Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Sep 15
Can-Fite BioPharma Ltd. Reports Complete Resolution of Esophageal Varices in Decompensated Cirrhosis Patient Treated with Namodenoson Can-Fite BioPharma Ltd. announced a significant new clinical finding under its compassionate use program in decompensated liver cirrhosis. The patient, previously reported by Can-Fite to have experienced the appearance of end-stage liver disease complications while receiving Namodenoson, has now demonstrated a complete resolution of esophageal varices, as confirmed by endoscopic evaluation. Esophageal varices are a common and severe complication of advanced liver disease, associated with a high risk of life-threatening gastrointestinal bleeding. Endoscopic images of the patient's esophagus before and after Namodenoson treatment demonstrate the appearance of varices under compassionate use therapy. Namodenoson is currently being evaluated in a Phase III clinical trial for the treatment of hepatocellular carcinoma (HCC) in patients with advanced liver disease (Child-Pugh B). Data from compassionate use cases may provide valuable supplementary evidence regarding its broader therapeutic potential. In 2017, an estimated 10.6 million people globally were affected by decompensated cirrhosis, and the available treatment options remain scarce, especially for patients who have reached the advanced stages of the disease. The Company's lead drug candidate, Piclidenoson reported topline results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma, a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Jul 30
Pancreatic Cancer Phase 2A Study with Can-Fite's Namodenoson Achieves over 50% Enrollment Milestone Can-Fite BioPharma Ltd. announced that it achieved the over 50% enrollment milestone in its Phase 2a trial of Namodenoson for pancreatic cancer. The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer. Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Announcement • Jul 29
Can-Fite BioPharma Ltd. Announces Breakthrough Study from University of Los Angeles Demonstrate Can-Fite's Piclidenoson as A Treatment for Vascular Dementia Can-Fite BioPharma Ltd. announced that a leading group from University of Los Angeles (UCLA), demonstrate that Piclidenoson showed efficacy in an experimental model of vascular dementia. The study headed by Dr. S. Thomas Carmichael, M.D., Ph.D., Professor and Chair Frances Stark Chair, Department of Neurology, Geffen School of Medicine at UCLA, utilized a vascular dementia mouse model with focalischemia replicating many elements of the complex pathophysiology of human vascular dementia. Vascular dementia is the second most common cause of dementia after Alzheimer's disease, and caused by impaired blood flow to the brain, often due to stroke or chronic small vessel disease. There are no U.S. FDA approved therapies for this condition. Drug that are used off-label, including donepezil or memantine, are used symptom or to address co-morbidities. Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile in hundreds of patients with Psoriasis and demonstrated anti-inflammatory activity in Phase 2 and Phase 3 clinical studies. Announcement • Jul 24
Can-Fite BioPharma Ltd. has filed a Follow-on Equity Offering. Can-Fite BioPharma Ltd. has filed a Follow-on Equity Offering.
Security Name: American Depositary Share
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 4,901,961
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 4,901,961
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 4,901,961 Announcement • Jun 18
Can-Fite to Present Phase IIa Pancreatic Cancer Study Progress During Partnering Meetings at the 2025 BIO International Convention in Boston Can-Fite BioPharma Ltd. announced that Dr. Sari Fishman, Vice President of Business Development, will present an update on the Company's ongoing Phase IIa study in pancreatic cancer during partnering meetings at the 2025 BIO International Convention, taking place June 16-19 in Boston, MA. The Phase IIa clinical trial is open-label study evaluating Namodenoson in patients with advanced pancreatic adocarcinoma whose disease has progressed following at least one prior line of therapy. The study is assessing the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson, administered orally at a dose of 25 mg twice daily in continuous 28-day cycles. The trial is led by Prof. Salomon Stemmer, a prominent Oncologist and Key Opinion Leader at the Davidoff Center, Rabin Medical Center, Israel. Namodenoson has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoon has been granted Orphan drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • May 19
Can-Fite BioPharma Ltd., Annual General Meeting, Jun 23, 2025 Can-Fite BioPharma Ltd., Annual General Meeting, Jun 23, 2025. Location: co. offices, Israel Announcement • Apr 17
Can-Fite Biopharma Ltd. Announces FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite's Namodenoson Can-Fite BioPharma Ltd. announced that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson. Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been awarded Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Apr 15
Can-Fite BioPharma Ltd. has filed a Follow-on Equity Offering in the amount of $3 million. Can-Fite BioPharma Ltd. has filed a Follow-on Equity Offering in the amount of $3 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 2,500,000
Price\Range: $1.2
Transaction Features: Registered Direct Offering Announcement • Mar 24
Can-Fite BioPharma Ltd. Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol Can-Fite BioPharma Ltd. announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol. The study will enroll patients with moderate to severe plaque psoriasis. Patients will be treated with 3 mg twice daily orally Piclidenoson tablets or placebo. The co-primary efficacy objectives of this study are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of 75% (PASI 75) and the proportion of subjects who achieve an Static Physician's Global Assessment (sPGA) at of 0 or 1 at Week 16. The FDA requested two Phase 3 safety and efficacy studies and also encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies. Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. Piclidenoson is a novel, robust anti-inflammatory first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug's mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients' skin cell keratinocytes involved with the disease pathogenicity. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer.amodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food & Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Mar 20
Can-Fite BioPharma Ltd. Announces to Initiate Phase II Study in Rare Genetic Disease Lowe Syndrome with Piclidenoson Can-Fite BioPharma Ltd. announced that a Phase II design is completed and preparatory work is undergoing for the initiation of clinical study in the rare genetic disease Lowe Syndrome. Dr. Franchesca Emma from the Division of Nephrology, Bambino Gesu Children's Hospital - IRCCS Rome Italy, will be the principal investigator of the study. Piclidenoson is a robust anti-inflammatory agent, currently being evaluated in a pivotal Phase III psoriasis clinical study under approval of both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Piclidenoson is an novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety profile demonstrating evidence of efficacy in Phase II and Phase III clinical studies. The drug's mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients' skin cell keratinocytes involved with the disease pathogenicity. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Mar 19
Can-Fite BioPharma Ltd. Receives Single FDA Approval for the Compassionate Use Treatment of U.S. Based Pancreatic Cancer Patient with its Anti-Cancer Drug Namodenoson Can-Fite BioPharma Ltd. announced that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson. Compassionate use is the term used when a physician is requesting for a single patient to gain access to an investigational drug for a serious disease. Such investigational drug has not yet been approved by the FDA. Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the FDA and the European Medicines Agency (EMA). The drug is currently being tested in Israel in a Phase IIa pancreatic cancer clinical study. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug. Announcement • Jan 27
Can-Fite BioPharma Ltd. Announces US Patent Office Granted Can-Fite Namodenoson Patent for Use as anti-Obesity Drug Can-Fite BioPharma Ltd. announced that its lead drug candidate Namodenoson was granted a patent for its use as an anti-obesity drug by the US patent office. Namodenoson is currently being developed for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), advanced liver cancer and pancreatic cancer. In all clinical studies that have been conducted, Namodenoson had a very favorable safety profile when administered orally. The patent application No. 17/309,952 entitled “An A3 adenosine receptor ligand for use for achieving a fat loss effect”, has been accepted by the US Patent Office, will be issued on February 2nd and expires in 2042. The patent application covers methods of treating obese patients by administering Namodenoson in an oral formulation. Can-Fite has already multiple approved patents and corresponding applications in a variety of territories around the world, for different clinical applications of the drug. The anti-obesity patent application is based on data demonstrating that treatment of fat cells with Namodenoson reduced fat levels via the increase of the hormone adiponectin, a regulator of fat production in the body. Namodenoson also reduced body weight in an experimental animal model of obesity, induced by high fat diet. In a MASH Phase IIa study, in patients treated with Namodenoson, a 2.3% weight loss has been observed after 3 months with a significant increase in serum adiponectin levels. The obesity treatment industry worldwide is expected to reach a projected revenue of USD 60.5 billion by 2030. A compound annual growth rate of 22.3% is expected of the worldwide obesity treatment industry from 2025 to 2030. Announcement • Dec 30
Recognition of the American Society of Clinical Oncology of the Liver Protective Effect of Can-Fite’s anti-Cancer Drug Namodenoson Can-Fite BioPharma Ltd. announced that its work titled “The Liver Protective Effect of the anti-Cancer Drug Candidate Namodenoson is Mediated via Adiponectin” will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium to take place at San Francisco & On Line, January 23-25. Currently, Namodenoson is being evaluated in a pivotal Phase 3 multinational registrational trial for the treatment of advanced liver cancer (Hepatocellular Carcinoma; HCC). Interestingly, Namodenoson has also completely cleared cancer in an HCC patient who was enrolled in Can-Fite’s Phase 2b HCC trial. The patient continues to be treated through a compassionate use program in Romania, where she remains cancer-free for more than 8 years following her first dose of Namodenoson. The uniqueness of Namodenoson is that beyond its anti-cancer activity, it also induces a liver-protective effect. The latter is manifested by anti-steatosis, anti-inflammatory, anti-fibrotic, and anti-ischemic effects in the liver. Can-Fite researchers also found that the molecular mechanism of the protective effect is mediated via adiponectin protein, a positive cytokine released by adipocytes and endothelial cells in the body, known to induce liver-, cardio-, and neuro-protective effects. Namodenoson has received significant acknowledgment in the scientific and medical communities, as evidenced by the numerous peer-reviewed publications and conferences, in which it has been published and presented. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Dec 04
Can-Fite Biopharma Ltd. Announces 8 Years Survival with Complete Cure for a Patient with Advanced Liver Cancer Being Treated with Can-Fite’s Namodenoson Drug Can-Fite BioPharma Ltd. announced that a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s Phase II Liver Cancer Study has an overall survival time of 8 years with a complete response. The patient, who suffered from advanced liver cancer was enrolled in the former Can-Fite Phase II study, continue to be treated with Namodenoson, and has now an overall survival of 8 years, with disappearance of ascites, normal liver function, good quality of life and is defined as a long term complete response. Can-Fite is currently enrolling patients in Israel, Europe and the US for a pivotal Phase III clinical study for patients with advanced HCC as a 2nd or 3rd line treatment and Namodenoson is administered twice daily orally. The study protocol has been agreed upon with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania. Announcement • Nov 12
Can-Fite BioPharma Ltd. Achieves Milestone with First Patient Dosing in Pancreatic Cancer Phase IIa Clinical Trial Can-Fite BioPharma Ltd. announced the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342). The Phase IIa study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study is being conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US. Orphan Drug Designation has been granted lately by US FDA. About Namodenoson: Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Oct 18
Can-Fite BioPharma Ltd.'s Partner Vetbiolix Reports Positive Results in Dog Osteoarthritis Study with Piclidenoson Can-Fite BioPharma Ltd. announced that its veterinary partner Vetbiolix reported positive final results from the osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner, which is covering all costs associated with veterinary clinical development, successfully concluded the full study. Vetbiolix already exercised its option to enter into a full in-license agreement with Can-Fite and is obligated to pay Can-Fite an upfront payment, milestone payments and royalties on sales upon regulatory approval, summing up to projected income of $325 Million to Can-Fite over the next 10 years. The study looked at the effect of 90 days treatment with Piclidenoson at 100 µg/kg and 500 µg/kg twice daily orally in dog patients with osteoarthritis. Including all evaluable patients, the primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary endpoints with a dose and time dependent inhibitory effect of Piclidenoson on LOAD and VAS, together with a favorable trend on NRS scores, demonstrating significant improvement in clinical status and decrease in pain utilizing the 500 µg/kg dose. There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs), which only treat symptoms and carry significant harmful side effects, and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. Announcement • Sep 16
Can-Fite BioPharma Ltd. Receives Approval from Israeli Ministry of Health to Conduct Phase IIa Clinical Trial with Orally-Administered Namodenoson in Treatment of Pancreatic Carcinoma Can-Fite BioPharma Ltd. announced that it received approval from the Israeli Ministry of Health (MoH) to conduct Phase IIa clinical trial with orally-administered Namodenoson in the treatment of pancreatic carcinoma. The Phase IIa is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients will receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study will be conducted by Dr. Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US. Announcement • Jul 01
Can-Fite BioPharma Ltd. Announces Improvement in Patient with Decompensated Liver Cirrhosis Upon Treatment with Namodenoson Can-Fite BioPharma Ltd. announced that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices. This drug candidate is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for MASH (metabolic dysfunction-associated steatohepatitis). Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression. In the past year Can-Fite has initiated a compassionate use program at the Soroka Medical Center, Beersheva, Israel, for the treatment of decompensated patients with Namodenoson. The first patient, a 63-year-old female with a history of decompensated primary biliary cirrhosis is now treated for one year with Namodenoson. Prior to the treatment with Namodenoson and despite best medical care for her underlying disease, she developed ascites and was admitted to the hospital with acute variceal bleeding. Currently, the patient shows improvement in liver function tests hematological parameters and FibroScan values and has not experienced any event of decompensation since starting treatment with Namodenoson. Namodenoson is known to induce liver protective effects in other liver pathologies, and Phase IIa data in patients suffering from MASH (metabolic dysfunction-associated steatohepatitis), responded positively to the drug, showing anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile. Decompensated cirrhosis is defined as an acute deterioration in liver function, with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression. An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. Underscoring the need for an effective treatment, the American Liver Foundation states there are more people who need a liver than supply available, and some people can be on the wait list for a liver transplant for more than 5 years. The treatment of liver cirrhosis globally is estimated to become an approximately $29.2 billion market by 2031. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Jun 29
Can-Fite BioPharma Ltd. Announces Positive Results from Osteoarthritis Clinical Study in Dogs Reported by Vetbiolix Can-Fite BioPharma Ltd. announced that its veterinary partner Vetbiolix reported positive results in an osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite's veterinary commercialization partner which is covering all costs associated with veterinary clinical development, concluded successfully the study interim analysis. Current treatments for osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease. Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug's mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients' skin cell keratinocytes involved with the disease pathogenicity. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. Announcement • Jun 24
Can-Fite Announces Breakthrough Findings Demonstrate Namodenoson Anti-Cancer and Protective Effect Mechanism in the Liver Can-Fite BioPharma Ltd. announces that company scientists came up with breakthrough findings showing that the anti-cancer and protective effects in the liver are conferred via the signalling protein adiponectin. This very important positive cytokine plays a pivotal role in regulating anti-inflammatory, anti-cancer, metabolic and insulin resistance. Namodenoson increases adiponectin production in pre-clinical studies and in humans. The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology, China Branch (IDDST-2024), September 12-14, Shanghai, China. This conference will host 300 leading scientists from the academia and industry worldwide to discuss the latest developments in drug discovery and therapy. Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Jun 13
Can-Fite Biopharma Ltd. Receives IRB Approval for the Treatment of Pancreatic Cancer with Namodenoson in a Phase IIa Study Can-Fite BioPharma Ltd. announced that it received an approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel where the study will be conducted. The approved protocol has been submitted now to the Ministry of Health (MOH). The protocol of the clinical study is CF102-222PC entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma," ClinicalTrials.gov Identifier: NCT06387342. The study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study will be conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel. Namodenoson recently received peer-reviewed recognition for its efficacy findings in pancreatic cancer including from the American Association of Cancer Research (AACR) which accepted Can-Fite's study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer, and from Biomolecules, a scientific journal focused on the function and mechanism of bioactive molecules, which published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/-catenin, NF-B, and RAS Signaling Pathways". Announcement • Jun 06
Can-Fite Biopharma Ltd. Updates on Its Advanced Liver Cancer Pivotal Phase 3 Study Can-Fite BioPharma Ltd. announced an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer. The Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania. In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years. The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Announcement • May 25
Can-Fite BioPharma Ltd., Annual General Meeting, Jun 26, 2024 Can-Fite BioPharma Ltd., Annual General Meeting, Jun 26, 2024. Location: co. offices, Israel Announcement • May 11
Can-Fite BioPharma Ltd. Announces FDA Grants IND Clearance for Namodenoson to Treat MASH Patients in a Phase IIb Study Can-Fite BioPharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company's ongoing Phase IIb clinical study. Namodenoson is a small molecule orally bioavailable drug, targeting the A3 adenosine receptor, over-expressed on the surface of liver pathological cells in MASH but not normal cells. This potentially makes Namodenoson an ideal specific candidate for the treatment of MASH. Indeed, in a Phase IIa clinical study Namodenoson, has been shown to reduce hepatic steatosis, inflammation and fibrosis, with an excellent safety profile. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA will allow for the recruitment of patients in the US. The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks. Announcement • May 08
Can-Fite BioPharma Ltd. Receives Notice of Allowance from the European Patent Office for the Treatment of Erectile Dysfunction with CF602 Can-Fite BioPharma Ltd. announced it received a Notice of Allowance from the European Patent Office for its patent application titled An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction. This invention addresses the use of the CF602 drug candidate as an oral or topical drug for patients such as diabetics, who suffer from erectile dysfunction, and cannot use the current drugs on the market. Can-Fite recently published an article in Andrologia, suggesting that CF602 could potentially offer an alternative to the current drugs on market. A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite’s CF602, an allosteric modulator of the A3 adenosine receptor (A3AR), applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure (ICM), smooth muscle/collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase. treatment to PDE5 inhibitors, particularly to PDE5 non-responders and diabetics. Announcement • Apr 03
Can-Fite Biopharma Ltd. Announces Submission of an Investigational New Drug Application to the U.S. Food and Drug Administration (Fda) for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis, Also Known as Non-Alcoholic Steatohepatitis, for the Company's Ongoing Phase IIb Clinical Study Can-Fite BioPharma Ltd. announced submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company's ongoing Phase IIb clinical study. Can-Fite's drug candidate, Namodenoson, has been shown to reduce hepatic steatosis, inflammation, and fibrosis, as well as body weight reduction, in a Phase IIa clinical study where data have been already published in a peer scientific journal. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study. The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks. Rates of MASH are increasing in the United States in concert with increasing rates of obesity and diabetes and is estimated to affect 2-5% of adult Americans. By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis, potentially paving the way for more drugs that target this huge market. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Dec 21
Can-Fite BioPharma Ltd. Reports New Data on Namodenoson’s Anti-Obesity Mechanism of Action Can-Fite BioPharma Ltd. reported new data on Namodenoson’s anti-obesity mechanism of action. New data demonstrate that treatment of fat cells (3T3-L1 adipocytes) with Namodenoson leads to modulation of proteins that increase adiponectin level. Adiponectin is a regulator of fat production in the cells, resulting in the inhibition of fat levels. Furthermore, Namodenoson reduced body weight in an experimental animal model of obesity induced by a high fat diet. In a Phase IIa NASH study, in patients treated with Namodenoson, a 2.1% weight loss was observed after 3 months of treatment (Safadi at Al) and a significant decrease in serum adiponectin levels was found. The global obesity treatment market is lucrative due to the awareness of a link between chronic diseases and obesity. The World Health Organization reports that obesity has nearly tripled since 1975 and at least 2.8 million people are dying as a results of obesity each year. According to Goldman Sachs Research, the anti-obesity medications market is estimated reached $6 billion on an annualized basis in 2023 and is expected to grow to $100 billion by 2030. Announcement • Dec 19
Can-Fite BioPharma Ltd. Receives Positive Response from U.S. Food and Drug Administration on Pediatric Study Plan for Treatment of Children Suffering from Psoriasis with Piclidenoson Can-Fite BioPharma Ltd. announced that it received a positive response from the U.S. Food and Drug Administration (FDA) on the Pediatric Study Plan for the treatment of children suffering from psoriasis with Piclidenoson. The plan has been submitted to allow enrollment of children with psoriasis to Can-Fite’s upcoming Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis. There is a high market need for a safe and efficacious drug for the treatment of children who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market, however all have safety issues and are not satisfactory regarding efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease. Can-Fite believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of children who endure the physical and emotional burden of this challenging disease. Announcement • Dec 05
Can-Fite BioPharma Ltd. Completes the Design of a Phase IIa Study Protocol for the Treatment of Pancreatic Cancer Patients Can-Fite BioPharma Ltd. announced that it completed the design of a Phase IIa study protocol for the treatment of patients with pancreatic cancer and plans to submit the protocol shortly to ethical committees for approval. Can-Fite completed the protocol design of the CF102-222PC clinical study entitled: "A Phase II Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma". This is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least 1st-line therapy or who refuse standard treatment. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. Announcement • Nov 22
Can-Fite Biopharma Ltd. Announces Complete Response and 6.9 Years Overall Survival in A Patient with Advanced Liver Cancer Treated with Namodenoson Can-Fite BioPharma Ltd. announced that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months). Liver Cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response. Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase III clinical study which is now enrolling patients in Israel, Europe and the US. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective. Announcement • Nov 02
Can-Fite Biopharma Ltd. Provides Business Update Can-Fite BioPharma Ltd. confirmed that all of the Company’s clinical and business development activities are ongoing and proceeding by both its Israeli and US based staff. The Company’s advanced-stage clinical pipeline includes two pivotal Phase III studies: an ongoing trial in advanced liver cancer and a psoriasis study that has been cleared by the U.S. Food and Drug Administration as well as the European Medicines Agency and is expected to commence enrollment shortly. Phase II trials include an ongoing study for steatotic liver disease (SLD), formerly known as NASH, and preparatory work is underway for a Phase IIa trial in pancreatic cancer. Can-Fite’s latest value-driving developments include its entry into the rare genetic diseases market with Piclidenoson which was found to be effective in pre-clinical studies for the treatment of Lowe Syndrome, an estimated $100 million treatment market in the U.S. alone in which there is no therapeutic treatment option available. Through a partnership with Collaborations Pharmaceuticals, Can-Fite will now utilize artificial intelligence (AI) and machine learning (ML) techniques to identify next-generation A3 adenosine receptor drug agonists and significantly reduce development time and costs of bringing such drugs to market. Announcement • Oct 31
Can-Fite Biopharma Ltd. Announces Namodenoson Inhibits Pancreatic Carcinoma Published in Leading Scientific Journal Can-Fite BioPharma Ltd. announced that as a result, death of pancreatic carcinoma cells takes place via apoptosis. This mechanism is highly important since pancreatic carcinoma cells are resistant to the chemotherapy. The Company is developing an exploratory Phase II study protocol that is designed to allow treatment of patients with pancreatic carcinoma who failed first line therapy. The study objectives will include safety and efficacy of the Namodenoson drug. Currently, Namodenoson is being evaluated in a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. Announcement • Aug 25
Can-Fite Enters Rare Genetic Disease Field Based on Impactful Findings of A Fondazione Telethon and Naples University Researcher Showing Piclidenoson Is Efficacious in Treating Lowe Syndrome Can-Fite BioPharma Ltd. announced it plans to develop its lead drug candidate, Piclidenoson, for the treatment of Lowe Syndrome based on recent efficacy findings by Dr. Antonella De Matteis, Professor of Biology, Department of Molecular Medicine and Medical Biotechnology at the University of Naples Federico II, and Program Coordinator of the Cell Biology and Disease Mechanisms at The Telethon Institute of Genetics and Medicine (TIGEM) in Italy. Can-Fite and Fondazione Telethon have signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment of Lowe Syndrome, a high medical need with no drug available. Fondazione Telethon is an Italian nonprofit organization whose mission is to advance biomedical research toward the diagnosis, cure, and prevention of genetic diseases, and it established TIGEM in 1994. Lowe Syndrome, also known as oculo-cerebro-renal syndrome (OCRL), an X-linked genetic condition occurring almost exclusively in males, is a multisystem disorder characterized by vision problems including clouding of the lenses of the eyes (cataracts) that are present at birth, kidney problems (consisting in urinary loss of proteins and solutes) that usually develop in the first year of life, and brain abnormalities associated with intellectual disabilities, and a life span that rarely exceeds 40 years. Lowe Syndrome prevalence is estimated at approximately 1 in 500,000. Can-Fite estimates the total addressable market for the treatment of Lowe Syndrome at approximately $100 million in the U.S. alone, based on incidence and cost of treatment for other rare genetic pediatric syndromes. The Company is not aware of any drug candidates currently in development for the systemic treatment of Lowe Syndrome. As a rare genetic pediatric disorder, Lowe Syndrome may qualify for Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), granting special development status to accelerate development at a reduced cost. The FDA’s Orphan Drug designation grants 7 years of market exclusivity, tax credits, waiver of the Prescription Drug User Fee Amendments fee (currently $3.1 million in 2022), and access to additional grants and support from the FDA. Piclidenoson for the treatment of Lowe Syndrome may also qualify for the FDA’s Rare Pediatric Disease Priority Review Voucher, granting an accelerated review process for marketing approval. Announcement • Aug 19
Can-Fite Biopharma Ltd. Submits Pediatric Plan to U.S. Food and Drug Administration to Allow Registration of Piclidenoson for the Treatment of Adolescents with Psoriasis Can-Fite BioPharma Ltd. announced that it submitted a pediatric study plan to the U.S. Food and Drug Administration (FDA) for the treatment of adolescents suffering from psoriasis with Piclidenoson. The plan has been submitted to allow enrollment of adolescents with psoriasis to Can-Fite’s upcoming two Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis. There is a high market need for a safe and efficacious drug for the treatment of adolescents who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market in use for adolescents with psoriasis, all have safety issues and are not satisfactory regarding the efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease. Can-Fite believes the inclusion of adolescent patients in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects million of people worldwide, including a significant number of adolescents who endure the physical and emotional burden of this challenging disease. Announcement • Jun 30
Can-Fite Biopharma Ltd. Receives U.S. FDA's Go Ahead for Piclidenoson Psoriasis Registration Plan Can-Fite BioPharma Ltd. announced that it received feedback and advice from the U.S. Food and Drug Administration with respect to non-clinical and clinical development and registration plans for Piclidenoson for the treatment of patients with moderate to severe plaque psoriasis. The FDA had a positive view of the non-clinical studies conducted by the Company and the accumulated safety data that the Company submitted to the agency as part of the registration plan. The FDA provided advice on the randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol with Piclidenoson that is aimed at demonstrating clinical safety and efficacy for the treatment of patients withmoderate to severe plaque psoriasis". The FDA requested two Phase 3 safety and efficacy studies and also encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies. To harmonize the requests of the European Medicines Agency and the FDA, Can-Fite plans to conduct two Phase 3 studies in parallel, including adolescent patients. Can-Fite believes the inclusion of adolescent patients in one or both of the Phase 3 studies significantly broadens the market launch potential of the drug. The Company believes that Piclidenoson represents a promising oral option for this underserved population. Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application to the U.S. FDA and Marketing Authorization Plan to the EMA. Announcement • Jun 24
Can-Fite BioPharma Ltd., Annual General Meeting, Jul 31, 2023 Can-Fite BioPharma Ltd., Annual General Meeting, Jul 31, 2023, at 15:00 Israel Standard Time. Location: 10 Bareket Street, Petach Tikva, Israel Petach Tikva Israel Agenda: To re-elect Abraham Sartani to Board of Directors as a Class I director, so that following such re-election, his term shall expire in accordance with his class; to re-elect Yaacov Goldman to Board of Directors as an external director for a three-year term ending July 24, 2026; to approve the grant of options to each of the Company's directors, excluding Dr. Pnina Fishman; to approve the grant of options to Dr. Pnina Fishman, incoming Chairman of the Board; to approve amendments to the terms of employment for Dr. Pnina Fishman as the Company's incoming Chairman of the Board of Directors; to approve amendments to the terms of employment for Mr. Motti Farbstein as the Company's incoming Chief Executive Officer; and to consider other matters if any. Announcement • Jun 14
Can-Fite BioPharma Ltd. to Submit IND for the Treatment of Pancreatic Cancer Patients with Namodenoson Can-Fite BioPharma Ltd. announced that it is doing all the preparatory work for an FDA Investigational New Drug (IND) submission for the treatment of pancreatic carcinoma with Namodenoson. Pre-clinical studies demonstrate a robust dose dependent anti-proliferative effect of Namodenoson on pancreatic carcinoma cells originating from both male and female patients, reaching 90% growth inhibition. An open-label Phase 2 exploratory trial to assess the safety and efficacy of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy will be initiated. Study endpoints will include safety, objective response, progression-free survival, duration of response, disease control (defined as an objective response or stable disease), and overall survival. The IND submission will cross reference all the data previously shared with the FDA related to the development of Namodenoson for the treatment of advanced liver cancer. Can-Fite is currently enrolling patients in a pivotal Phase 3 study in hepatocellular carcinoma, in agreement with both the FDA and the European Medicines Agency (EMA). Announcement • May 10
Can-Fite BioPharma Ltd. to Initiate Exploratory Phase 2 Trial with Namodenoson in Pancreatic Cancer Patients Can-Fite BioPharma Ltd. announced that it will initiate an open-label Phase 2 exploratory trial to assess the efficacy and safety of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy. Patients will receive Namodenoson at a dose of 25 mg orally, twice daily. Efficacy endpoints will include objective response, progression-free survival, duration of response, disease control (defined as an objective response or stable disease), and overall survival. Safety will be assessed as well. The study will be conducted by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute of Oncology, Rabin Medical Center, Israel. Namodenoson is currently under a pivotal Phase 3 study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment. The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030. Announcement • Feb 16
Can-Fite Biopharma Ltd. Announces Namodenoson Is Approved for Compassionate Use in the Treatment of Liver Cancer in Israel and Romania Can-Fite BioPharma Ltd. announced that Purinergic Signalling, a peer-reviewed scientific journal focused on molecules which target adenosine receptors, published an article titled "Targeting the A3 adenosine receptor to treat hepatocellular carcinoma: anti-cancer and hepatoprotective effects" authored by Can-Fite's CEO Dr. Pnina Fishman and others. The article includes a review of the novel approach for treating advanced liver cancer with Namodenoson, a small molecule orally bioavailable drug which specifically kills cancer cells and leaves normal liver cells unharmed. Efficacy and safety data are presented from Phase I and II human clinical studies. Treatment with Namodenoson resulted in longer overall survival in patients with advanced liver cancer as defined by Child Pugh B (CPB) stage in a statistically significant manner. The drug has shown to have a very favorable safety profile and exert a protective effect on liver cancer cells. Currently, Namodenoson is being evaluated in a pivotal Phase III study. The study protocol has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) with 450 patients to be enrolled in Israel, Europe, and the U.S. An interim data analysis will be performed. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Jan 25
Can-Fite BioPharma Ltd. Announces Namodenoson Significantly Inhibits Pancreatic Cancer in Preclinical Studies Can-Fite BioPharma Ltd. announced that its anti-cancer drug Namodenoson significantly inhibits the growth of pancreatic carcinoma as a stand-alone treatment. In combination with the leading chemotherapy used in pancreatic cancer, gemcitabine, Namodenoson demonstrated a significant additive effect. These pre-clinical studies were conducted on advanced pancreatic carcinoma patient cells. Namodenoson’s molecular mechanism of action in pancreatic cancer involves the regulation of the NF-?B /I?B /STAT3-mediated pathway. Namodenoson is currently being evaluated in a pivotal Phase III study in advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Jan 11
Can-Fite BioPharma Ltd. Submits Market Registration Plan to European Medicines Agency for Piclidenoson in the Treatment of Psoriasis; U.S. Food and Drug Administration Submission to Follow Can-Fite BioPharma Ltd. announced it has submitted a market registration plan to the European Medicines Agency for its lead drug candidate Piclidenoson in the treatment of moderate to severe psoriasis. A submission to the U.S. Food and Drug Administration (FDA) will follow. Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT™ Phase III study and the protocol for the Company’s upcoming Phase III pivotal trial together with a request for registration advice from the regulators. Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included. Can-Fite recently reported topline results from its Phase III COMFORT™ study which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and an excellent safety profile for Piclidenoson. The Phase III COMFORT™ data point towards a better safety profile for Piclidenoson as compared to Otezla, the leading oral therapy for psoriasis on the market today, as Otezla induced: 1) gastro-intestinal adverse events in 6% of patients compared with 1% in patients treated with placebo or Piclidenoson; and 2) 9.9% nervous system disorders in the Otezla vs. 0.7% in the Piclidenoson treated patients. Announcement • Mar 19
Can-Fite BioPharma Ltd. Announces New Data from Preclinical Study of Its Drug Candidate CF602 in the Treatment of Erectile Dysfunction in Diabetes Experimental Model Can-Fite BioPharma Ltd. announced new data from a preclinical study of its drug candidate CF602 in the treatment of erectile dysfunction in diabetes experimental model. The study evaluated the efficacy of topically applied CF602 in a 4-cohort study with diabetic Sprague-Dawley rats receiving placebo; 100nM CF602; 500nM CF602. Naïve rats served as a comparative negative control. Treatment with CF602 at a dose of 500 nM resulted in statistically significant improvement of erectile dysfunction compared to vehicle treated controls when measured in a two-way ANOVA followed by Bonferroni multiple comparisons post-hoc analysis. The improvement was even better than recorded for the naïve animals group. Efficacy was dose-dependent. Announcement • Mar 06
Can-Fite Enrolls First Patient in Phase II COVID-19 Study Under FDA Protocol Can-Fite BioPharma Ltd. announced it has enrolled the first of 40 patients in its Phase II COVID-19 study. The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson twice daily or placebo, and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen. Safety and pharmacokinetic data will also be captured. Piclidenoson’s robust anti-inflammatory effect has the potential to treat COVID-19 and its mutations because it treats disease manifestations. The drug has anti-inflammatory effects proven in Phase II psoriasis clinical studies and in an interim analysis of an ongoing Phase III psoriasis study. The drug’s anti-viral properties are protected by U.S. patent US7589075. Piclidenoson also inhibits cytokine release syndrome which is associated with the severity of COVID-19. Announcement • Feb 23
Can-Fite Biopharma Ltd. Announces New Data from the Phase Ii Advanced Liver Cancer Study Can-Fite BioPharma Ltd. announced new data from the Phase II advanced liver cancer study including overall survival of nearly 4 years in two patients who are under namodenoson treatment. Additional findings show disappearance of ascites, normal liver function and good quality of life. In one patient stable disease has been recorded with disappearance of peritoneal carcinomatosis. Namodenoson continues to demonstrate a good safety profile and is well tolerated with no severe adverse events reported. Recently, the Company successfully concluded End-of-Phase II meetings with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Both agencies agreed with Can-Fite's proposed pivotal Phase III trial design of Namodenoson for the treatment of patients with advanced hepatocellular carcinoma (HCC), with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. The trial is expected to enroll 450 patients through multiple centers worldwide. Namodenoson has Orphan Drug Designation for HCC in the U.S. and Europe, has Fast Track Status in the U.S., and is currently treating liver cancer patients through a compassionate use program in Israel. Announcement • Feb 02
Can-Fite Announces Inhibition of Liver Fibrosis by Cannabis Compounds in Preclinical Studies Can-Fite BioPharma Ltd. announced it has completed a set of pre-clinical studies demonstrating that CBD rich T3/C15 cannabis fractioninduces an inhibitory effect on liver fibrosis. Fibrosis of the liver occurs when injured or inflamed liver cells can no longer repair themselves, resulting in an abnormally large amount of scar tissue. Liver fibrosis is associated with increased liver disease including nonalcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), cirrhosis, and liver cancer. As a global leader in discovering and developing drugs which target the A3 adenosine receptor (A3AR), Can-Fite showed that cannabis derived compounds bind to A3AR, mediating therapeutic effects. CBD rich T3/C15 cannabis fraction inhibited the proliferation of LX-2 hepatic-stellate cells, the liver cell type mediating the development of fibrosis. This inhibitory response was neutralized by an antagonist to the A3AR, demonstrating that the anti-fibrotic effect was mediated via the A3AR.Can-Fite’s small molecule drug candidate Namodenoson has shown efficacy in liver diseases and is headed into a pivotal Phase III in liver cancer and a Phase IIb in NASH. The Company has filed patent applications protecting its discovery of cannabinoid-based treatments where A3AR is overexpressed including liver cancer, other cancers, autoimmune, inflammatory, and metabolic diseases. Announcement • Jan 09
Can-Fite BioPharma Ltd Announces Publication of Namodenoson Liver Cancer Study in Peer Reviewed Journal—Cancers Can-Fite BioPharma Ltd. announced a scientific paper titled, “Namodenoson in Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial” was published in the peer reviewed journal Cancers. The paper highlights and analyzes results from Can-Fite’s Phase II study, a randomized placebo-controlled trial to investigate Namodenoson as a 2nd-line treatment for advanced hepatocellular carcinoma (HCC) and moderate hepatic dysfunction, as defined by Child–Pugh B (CPB) scores of 7–9. Even though the trial did not meet its primary endpoint, in patients with a CPB score of 7, Namodenoson was associated with a significant improvement in 12-month overall survival and 2 patients are still under treatment for more than 3.5 years. A pivotal Phase III study of Namodenoson as a 2nd or 3rd line treatment in HCC CPB7 patients has been designed, and both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed with the protocol. Upon successful results, the trial may lead to concurrent marketing approval in the U.S. and Europe. Namodenoson has been granted Orphan Drug Status by both the FDA and EMA, in addition to Fast Track Status by the FDA. Namodenoson continues to be administered to HCC patients under a compassionate use program in Israel. Announcement • Dec 17
Can-Fite Biopharma Ltd. Receives Israel Ministry of Health Approval to Conduct Research with Cannabinoids in Cancer, Inflammation and Obesity at the Company Discovery Labs Can-Fite BioPharma Ltd. announced it has received approval from the Medical Cannabis Unit of Israel’s Ministry of Health to conduct pre-clinical studies on the effect of nanomolar concentrations of cannabinoid fractions on the proliferation and functionality of cancer, inflammatory and adipocyte cells (fat cells). This regulatory approval clears Can-Fite to advance its cannabinoid program by evaluating the effect of cannabis fractions at nanomolar concentrations binding with the A3 adenosine receptor (A3AR), the target of the Company’s technology, in a broad range of diseases including cancer, inflammatory diseases, and metabolic diseases associated with fat accumulation. Can-Fite’s recent findings show that cannabinoids can be clinically effective at minute concentrations, thereby potentially delivering efficacy without the adverse effect seen to occur with high cannabinoid concentrations as evidenced in the scientific literature. Prior pre-clinical studies jointly conducted by Can-Fite and Univo Pharmaceuticals demonstrate cannabinoid fractions inhibited liver cancer cell proliferation through A3AR. Can-Fite will conduct the research in its own discovery labs where it recently developed patent-pending cannabinoid-based formulations and an in vitro biological assay to identify clinically active cannabis derived compounds. The Company’s recently filed patent application covers the use of cannabinoids in treating A3AR associated conditions including cancer, autoimmune, inflammatory, and metabolic diseases. Can-Fite’s biological cell-based assay will be utilized in the development of pharmaceuticals that use a specific cannabis derived compound to treat a variety of diseases. In addition to benefitting from its assay in the development of its own cannabis derived compound-based therapeutics, Can-Fite plans to market the assay on a ‘fee for service’ basis to researchers and other cannabis companies worldwide. Announcement • Dec 15
Can-Fite BioPharma Ltd. Announces Namodenoson Drug Candidate for Non-Alcoholic Steatohepatitis Treatment Can-Fite BioPharma Ltd. announced the following progress with its Namodenoson drug candidate for non-alcoholic steatohepatitis (NASH) treatment:
The company is currently engaged in the design of a Phase IIb study for Namodenoson in the treatment of NASH. The protocol is being developed in conjunction with leading Key Opinion Leaders (KOLs) in NASH and liver diseases including Dr. Scott Friedman, Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York, and Dr. Stephen A. Harrison, Medical Director of Pinnacle Clinical Research, both of whom were involved in the design of Namodenoson’s successfully completed Phase II study in NAFLD/NASH which achieved its efficacy endpoints. Drug supply - Manufacturing of Namodenoson for the upcoming clinical study has been completed. NASH patents were issued by the U.S. & European patent offices. Can-Fite’s NASH clinical program is now protected by claims covering the use of the A3 adenosine receptor (A3AR), the target of Can-Fite’s platform technology, in reducing ectopic fat accumulation particularly in fatty liver as manifested in nonalcoholic fatty liver disease (NAFLD) and NASH. Namodenoson for the treatment of NASH is licensed for distribution in Korea and China in deals that include upfront and milestone payments. NASH is a clear and urgent unmet medical need, as there is currently no U.S. FDA approved treatment for the disease. NAFLD is characterized by excess fat accumulation in the liver. According to a study published in Hepatology, an estimated 17%-33% of the population in the U.S. has NAFLD, while the NIH estimates the incidence of NASH in the U.S. at 2-5% of the population. Incidence is increasing based on rising obesity rates. If untreated, NASH can lead to cirrhosis and liver cancer. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Announcement • Dec 03
Can-Fite BioPharma Ltd., Annual General Meeting, Dec 09, 2020 Can-Fite BioPharma Ltd., Annual General Meeting, Dec 09, 2020, at 12:00 Israel Standard Time. Location: 10 Bareket Street Petach Tikva Israel Announcement • Nov 24
Can-Fite BioPharma Ltd. to Report Q3, 2020 Results on Nov 30, 2020 Can-Fite BioPharma Ltd. announced that they will report Q3, 2020 results on Nov 30, 2020 Announcement • Nov 17
Can-Fite Biopharma Ltd. Announces That Dr. Rifaat Safadi, Principal Investigator of the Company's Phase Ii Study of Namodenoson in the Treatment of Nafld/Nash Delivered A Late-Brweaking Oral Presentation At the Aasld Conference Can-Fite BioPharma Ltd. announced that Dr. Rifaat Safadi, Principal Investigator of the Company's Phase II study of Namodenoson in the treatment of NAFLD/NASH delivered a late-brweaking oral presentation at the AASLD conference, The Liver Meeting Digital Experience 2020. Titled "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study Of The Efficacy And Safety Of Namodenoson (CF102), An A3 Adenosine Receptor (A3AR) Agonist, In Treating Non-Alcoholic Fatty Liver Disease (NAFLD) And Non-Alcoholic Steatohepatitis (NASH)" the oral presentation was given on Sunday, November 15 by Dr. Safadi, Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center, Professor of Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at Hebrew University in Israel. The double-blind, placebo-controlled, dose-finding efficacy and safety study enrolled 60 patients with NAFLD with or without NASH. Patients with evidence of an active inflammation were treated twice daily with 12.5 mg (n=21) or 25 mg (n=19) of oral Namodenoson vs. placebo (n=20). The patients were treated for 12 weeks and followed-up until week 16. As a result of the study, 25 mg was determined to be the optimal dose. Announcement • Oct 07
Can-Fite BioPharma Ltd. Announces Positive Phase III Psoriasis Interim Data Analysis Can-Fite BioPharma Ltd. announced that the Independent Data Monitoring Committee (IDMC) which conducted an interim analysis of the Company’s Phase III Comfort™ trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis, recommended, based on the positive data, to continue the study with the original sample size and drop one dose group. This means that an optimal dose has been found and that the study can be concluded earlier than has been originally planned. A separate IDMC for the interim analysis of the Acrobat™ Rheumatoid Arthritis Phase III studyrecommended not to continue this study. The Company plans to undertake a detailed analysis of the data of the RA study and decide on the next steps. Can-Fite’s Comfort™ Phase III psoriasis study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla®) in patients with moderate to severe plaque psoriasis. The randomized, double blind study is being conducted in Europe, Israel, and Canada. Patients were randomized into four groups: 2 mg Piclidenoson, 3 mg Piclidenoson, Otezla®, and placebo. The study’s primary endpoint is the proportion of patients who achieve a PASI score response of =75% (PASI 75) vs. placebo at week 16. The secondary endpoints include non-inferiority to Otezla® on weeks 16 and 32. The majority of costs associated with the Phase III Comfort™ study were previously paid, and based on the Company’s current cash and its anticipated uses, the Company believes it has sufficient runway to cover the completion of this study. Piclidenoson has been out-licensed for the indication of psoriasis in Canada, South Korea, Spain, Austria, Switzerland, Hong Kong, Macau, Taiwan, and China. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases and for the treatment of COVID-19. It is being evaluated in multinational Phase III studies as a first line treatment to replace methotrexate in the treatment of rheumatoid arthritis, and as a treatment for moderate-to-severe psoriasis. Announcement • Aug 21
Can-Fite BioPharma Ltd. to Report Q2, 2020 Results on Aug 27, 2020 Can-Fite BioPharma Ltd. announced that they will report Q2, 2020 results at 12:00 PM, GMT Standard Time on Aug 27, 2020 
