Announcement • Apr 03
Therapeutic Solutions International, Inc. announced delayed annual 10-K filing On 04/02/2025, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Nov 15
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 11/14/2024, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Aug 16
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 08/15/2024, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 17
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 05/15/2024, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Apr 02
Therapeutic Solutions International, Inc. announced delayed annual 10-K filing On 04/01/2024, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Mar 05
Therapeutic Solutions International Receives Patent on Commercially Available QuadraMune Nutraceutical for Increasing Natural Killer Cell Immunity in COVID-19 Patients Therapeutic Solutions International, Inc. (TSOI) announced the granting of a patent covering the ability of QuadraMune and similar compositions, to stimulate natural killer (NK) cell activity in patients with COVID-19. NK cells are the first line of defense against viruses and cancers. Announcement • Oct 21
Therapeutic Solutions International, Inc. Announces Successful First Treatment of Patient with FloraStilbene Therapeutic Solutions International, Inc. announced the successful first treatment of a patient with FloraStilbene™, a patent pending formulation of the abortion pill’s active ingredient, RU486, and pterostilbene. The Company has been utilizing pterostilbene, a naturally occurring analog of resveratrol, found in blueberries, for the treatment of cancer and immune modulation for several years, including being granted a patent on synergies with conventional immunotherapies. In May of this year, Res Nova signed a collaborative agreement with compounding pharmacy Cure Stat Rx for developing a compounded formulation of FloraStilbene™. FloraStilbene™ has previously been shown to enhance immunotherapy of various tumors, as well as chemotherapy efficacy. In addition to Res Nova, Therapeutic Solutions International has multiple subsidiaries including Campbell Neurosciences, focused on the identification of suicidal propensities using a proprietary test and various interventions; Breath Biologics, which is in discussions with the FDA for its filed Phase I/II trial in COPD; CTE Biologics, which is advancing its clinical stage technology for treating Chronic Traumatic Encephalopathy; and VasoSome Vascular, which is in preclinical development of mesenchymal stem cell derived exosomes for treatment of aortic aneurysms. Announcement • Oct 18
Res Nova Bio Appoints George Delgado to Scientific Advisory Board The original source-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the source-language text, which is the only version of the text intended to have legal effect. Therapeutic Solutions International, Inc. (TSOI), announced its breast cancer focused immunotherapy subsidiary company, Res Nova Bio, has recruited internationally renowned medical doctor George Delgado to its Scientific Advisory Board. Dr. Delgado is an expert in the biology of pregnancy and the abortion pill, being the founder of “Abortion Pill Reversal” and having been the first to publish in the peer-reviewed literature successful reversal of mifepristone administration using progesterone treatment. Res Nova is developing FloraStilbene™, a proprietary formulation of RU-486 and pterostilbene which has been shown to overcome tumor associated immune suppression and increases responsiveness to chemotherapy and immunotherapy. The Company has signed a collaborative agreement with Cure Stat Rx, a premiere compounding pharmacy and plans to eventually commercialize through the 505b2 pathway. Dr. Delgado received his undergraduate degree at St. Mary’s College of California where he graduated summa cum laude and received the biology department’s top honor — the Carlos Freitas Award. He attended medical school at UC Davis and completed his residency training at Santa Monica Hospital/UCLA. He has given numerous presentations to various groups on medical and bioethical topics. Announcement • Oct 01
Therapeutic Solutions International, Inc. Announces Paradigm Shifting Immunotherapy Product: Tolerogenic Neutrophils Therapeutic Solutions International, Inc. announced a patent filing covering the unanticipated finding that neutrophils, a type of white blood cell, when manufactured in a specific manner, are capable of stopping unwanted immune responses while allowing the body to fight bacteria and viruses. Classical immunology doctrine teaches that these cells act as "first responders" but not as "leader cells", a function which has been classically ascribed to T helper cells. In a series of experiments, it was found that neutrophils generated from hematopoietic stem cells in the presence of an immunological messenger molecule named IL-10, could potently block rejection responses when these cells were administered in different strains of mice. Importantly the injected cells allow other cells from the same donor to not be rejected, allowing for transplantation of therapeutic cells. Announcement • Sep 19
Therapeutic Solutions International Appoints Navneet Boddu to Scientific Advisory Board Therapeutic Solutions International, Inc. announced the appointment of internationally renowned stem cell therapist Dr. Navneet Boddu to the Company’s Scientific Advisory Board. Dr. Boddu joins eminent luminaries in the regenerative medicine/immunotherapy space such as Dr. Santosh Kesari, Dr. Francesco Marincola1, Dr. Donald Banerji2, and Dr. Boris Minev3. Dr. Boddu previously obtained for Therapeutic Solutions International Emergency IND approval to treat a patient with COVID-19 using JadiCells. Therapeutic Solutions International plans to expand ongoing patient access to JadiCells as it advances in their development. Dr. Boddu is affiliated with Scripps Memorial Medical Center, Encinitas; Tri City Medical Center; North Coast Surgery Center; and Carlsbad Surgery Center. He is board certified in Pain Medicine, Anesthesiology and Echocardiography. Dr. Boddu was chosen as Top Doctor of San Diego in 2022, 2021, and 2017. Announcement • Aug 22
Therapeutic Solutions International, Inc. Announces FlorStilbene™? Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer Therapeutic Solutions International, Inc. (TSOI) reported that its breast cancer immunotherapy spin-off company, Res Nova Bio, released data showing synergistic suppression of breast cancer growth when used in combination with anti-PD1 and anti-CTLA4 antibodies, which represent clinically used checkpoint inhibitors such as Keytruda and Yervoy, respectively. Additionally, the Company demonstrated that FloraStilbene™? administration increased efficacy of the standard chemotherapies Taxotere and Cytotoxan which are used in breast cancer. The data were filed in a patent application covering adjuvant use of Flora Stilbene™? in radiotherapy, oncolytic virus therapy, adoptive cellular therapy, chimeric antigen receptor therapy, chemotherapy and immunotherapy. Studies have shown that the abortion pill reduces activity of the cytokine TGF-beta which is involved in protecting the fetus from the maternal immune response, as well as protecting cancer cells from immunity of the body. At a cellular level immature dendritic cells, which are found in both cancer and pregnancy seem to be stimulated to maturation by treatment with the abortion pill. Announcement • Jul 21
Therapeutic Solutions International Subsidiary Res Nova Bio Inc Discovers New Mechanism of Action for Breast Cancer Immunotherapy Adjuvant FloraStilbene™ Therapeutic Solutions International, Inc. (TSOI), announced that its breast cancer focused immuno-oncology subsidiary, Res Nova Bio, Inc., has identified and filed a patent on a novel mechanism of action of its immunotherapy-enhancing product FloraStilbene™. The Company has demonstrated that administration of FloraStilbene™, which is a proprietary combination of pterostilbene and the active ingredient in the abortion pill, mifepristone, suppresses loss of T cell activity caused by growing breast cancer. In a series of experiments, it was demonstrated that FloraStilbene™ stopped degradation of a protein called “T cell receptor zeta chain” which has previously been shown to be inactivated by the enzyme caspase-31. Breast cancer patients with higher levels of T cell receptor zeta chain have been reported to possess superior survival as compared to patients with lower levels2. Announcement • May 17
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 05/16/2023, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Nov 16
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 11/15/2022, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Nov 15
Therapeutic Solutions Announces Universal Donor Myeloid Derived Suppressor Therapy Platform for Treatment of Chronic Obstructive Pulmonary Disease Therapeutic Solutions International announced new data, licensing, and patent filing on a novel cellular therapy for treatment of Chronic Obstructive Pulmonary Disease (COPD) by its Spin-Off Company Breathe Biologics. The Company disclosed that administration of monocytic progenitors derived from umbilical cord blood treated under proprietary conditions were able to reduce inflammation and preserve lung function in the elastase mediated animal model of COPD. The cellular product possessed characteristics of pulmonary progenitor cells combined with immune regulatory myeloid suppressor cells. Furthermore, it was demonstrated that blockade of the cytokine’s interleukin-10 and/or interleukin-17 negated the therapeutic effect of the cells, thus suggesting a possible mechanism of action for this novel cellular therapy. Breathe Biologics is developing the use of JadiCells, a stem cell product in Phase III for COVID ARDS, for the treatment of COPD under IND# 28508. Breathe Biologics has acquired the IND from Therapeutic Solutions International as part of its initial licensing. Announcement • Oct 25
Therapeutic Solutions International Announces Successful Treatment of Epilepsy in Animal Model and Complete Cessation of Seizures in Treatment Resistant Patient Therapeutic Solutions International (TSOI) announced successful administration of JadiCells into a treatment resistant epilepsy patient resulting in a profound recovery. The patient was treated under the Right to Try Act as a result of preclinical data demonstrating significant advantage of JadiCells™ compared to standard umbilical cord mesenchymal stem cells in the pilocarpine-induced animal model. The company has filed a patent application covering the use of JadiCells™ for treatment of epilepsy and associated conditions. JadiCells™ are subject of a Phase III trial that the Company is performing for treatment of COVID-19. Additionally, the cells have been granted IND numbers for chronic obstructive pulmonary disease1, and for Chronic Traumatic Encephalopathy2, for which the Company is working with the FDA to initiate clinical trials. The Company has also successfully treated 15 patients with CTE or COVID-19 under Right to Try and Emergency IND3. Announcement • Oct 06
Therapeutic Solutions International Identifies Cd103 Expressing Dendritic Cells and Exosomes Thereof as Novel Mechanism for Jadicell Mesenchymal Stem Cell Mediated Lung Protection Therapeutic Solutions International (TSOI) announced new data suggesting that therapeutic effects of its universal donor stem cell product are mediated in part through CD103 expressing dendritic cells. In a series of experiments, it was found that protection against both Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Distress Syndrome (ARDS) could be transferred to naïve mice by dendritic cells expressing the molecule CD103. Furthermore, exosomes, which are nanoparticles produced by cells, were capable of transferring protection to naïve mice. Therapeutic Solutions International is currently running a Phase III clinical trial using JadiCells in the treatment of COVID-19 associated ARDS. Additionally, the Company has an Investigational New Drug Application IND# 28508 for treatment of COPD, for which the Company is still in discussions with the FDA. Announcement • Sep 21
Therapeutic Solutions International, Inc. announced that it expects to receive $10 million in funding from GHS Investments, LLC Therapeutic Solutions International, Inc. announced that it has entered into a common stock purchase agreement with GHS Investments, LLC for issuing common stock for gross proceeds of $10,000,000 on September 19, 2022. The common stock has a par value of $0.001 per stock. The company will issue the stock in multiple tranches. Announcement • Sep 20
Therapeutic Solutions International Announces Positive Data and Filing of Patent Covering the Use of Campbellcell for Treatment of Bipolar Disorder by the Company’S Suicide Prevention Based Spin-Off Campbell Neurosciences Therapeutic Solutions International announced positive data and filing of a patent covering the use of CampbellCell for treatment of Bipolar Disorder by the Company’s suicide prevention based spin-off Campbell Neurosciences. In a series of animal experiments using an established animal model of bipolar disorder, superior inhibition of behavioral abnormality as measured in the “Open Field Test”, as well as reduction in brain inflammation wasobserved in animals treated with CampbellCell as compared to control stem cells. Furthermore, it was found that protection from behavioral abnormalities could be transferred to naïve mice by T cell infusions, indicating thatan immunological effect was present. Announcement • Sep 13
Therapeutic Solutions International Develops Post Jadicell Maintenance Therapy for Chronic Obstructive Pulmonary Disease Therapeutic Solutions International, Inc. announced data and patent filing on a new approach to treating chronic obstructive pulmonary disease (COPD). The Company demonstrated that administration of a combination of the FDA approved drug G-CSF, together with a proprietary anti-oxidant/NF-kappa B inhibiting formulation resulted in suppression of COPD in the elastase animal model. Furthermore, the Company demonstrated synergy between the new approach and JadiCell administration. Therapeutic Solutions International currently has an ongoing Phase III clinical trial for COVID-19 induced Acute Respiratory Distress Syndrome and has been granted an IND number by the FDA for treatment of COPD. Announcement • Aug 30
Therapeutic Solutions International Develops Gene Silencing Therapy for Acute Respiratory Distress Syndrome Therapeutic Solutions International announced data and filing of a patent covering the use of “gene silencing” in treatment of Acute Respiratory Distress Syndrome (ARDS), a leading cause of death in emergency rooms. The Company currently is running a Phase III trial treating COVID-19 induced ARDS but has requested permission from the FDA to expand to ARDS caused by other precipitating factors. The new data demonstrates feasibility of selectively silencing genes in the lung associated with mortality caused by ARDS, as well as a potent survival advantage in treated versus untreated mice. An approximately 70% reduction in mortality was observed in mice receiving siRNA specifically towards the target genes as compared to mice receiving scrambled siRNA in a TLR4 agonist induced model of ARDS. The Company plans to continue development of this approach, which is attempted to synergize with the current regenerative medicine programs currently underway. Announcement • Aug 26
Therapeutic Solutions International Files with FDA to Expand ongoing Phase III Clinical Trial to Include All Causes of Acute Respiratory Distress Syndrome Therapeutic Solutions International announced filing with the Food and Drug Administration (FDA) an amendment to its currently open Phase III clinical trial requesting expansion of eligible patients with all patients suffering from Acute Respiratory Distress Syndrome (ARDS) regardless of cause. The Company is currently only recruiting patients with advanced ARDS caused by COVID-19. The newly proposed criteria will allow all patients suffering from this condition to be eligible for entry into the clinical trial. Before the COVID-19 outbreak ARDS was believed to be approximately 200,000 cases per year in the United States and represents a multi-billion-dollar market. Currently there are no curative interventions available for advanced ARDS. Announcement • Aug 16
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 08/15/2022, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Aug 13
Therapeutic Solutions International, Inc. Reports Superior Efficacy of ApoptoCyte™ on Chronic Obstructive Pulmonary Disease Model Compared to Conventional Stem Cell Approaches Therapeutic Solutions International announced new data demonstrating superior effects of the Company’s ApoptoCyte™ procedure treated JadiCell™ product compared to other stem cells in treating an animal model of Chronic Obstructive Pulmonary Disease (COPD). In a series of experiments, mice were administered the enzyme elastase to mimic COPD. It was shown that untreated JadiCell stem cells, as well as stem cells from sources conventionally utilized, specifically fat and bone marrow, had some therapeutic activity including reduction of inflammation, stimulation of regenerative growth factors, and preservation of alveoli structure1. All cell types had improved therapeutic activity when processed using the ApoptoCyte procedure, with JadiCell possessing the highest activity. The Company possesses IND #28508 for using non-modified JadiCells for COPD, however the clinical trial is expected to initiate following further discussions between the Company and the FDA. Additionally, the Company currently is running a Phase III clinical trial using JadiCells for treatment of advanced COVID-19 infection. Announcement • Jul 29
Therapeutic Solutions International Creates Disease Specific Therapeutic Platform Based on Gene Editing/Engineering of Inducible Pluripotent Stem Cells Therapeutic Solutions International reported the successful generation of gene-edited and/or gene-modified regenerative cells possessing mixtures of properties between mesenchymal stem cells and tolerance inducing immune cells. The cellular platform allows for creation of cells that are unique to the disease indication and provide a combination of regenerative as well as tolerogenic activities. The Company has generated and filed intellectual property on a variety of disease-specific modifications of iPSC line. Importantly, creation of “hybrid cells” which possess tolerogenic and regenerative potential. Announcement • Jul 19
Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell™ Universal Donor Stem Cell for COVID-19 ARDS Outside of Ongoing Phase III Clinical Trial Therapeutic Solutions International announced granting of Emergency IND # 28685 and a “May Proceed Notification” from the Food and Drug Administration (FDA) for the treatment of advanced COVID-19 ARDS outside of the currently ongoing Double Blind Placebo Controlled Phase III clinical trial for the same indication. The Company previously announced treatment of 15 "no option patients” under both “eIND” and “Right to Try” Law. Previously the Company has demonstrated superior activity of JadiCells to other stem cells, as well as identifying mechanisms of action. The JadiCell is currently in Phase III for COVID-19 ARDS, has been granted IND numbers for COPD, and Chronic Traumatic Encephalopathy, and is in late preclinical development for Idiopathic Pulmonary Fibrosis. Announcement • May 26
Therapeutic Solutions International Appoints Donald Banerji to Scientific Advisory Board Therapeutic Solutions International announced the appointment of Dr. Donald Banerji to the Company’s Scientific Advisory Board. Dr. Banerji joins internationally renowned opinion leaders including Dr. Santosh Kesari, Chair of Department of Translational Neuro-Oncology and Neurotherapeutics at the John Wayne Cancer Institute, Dr. Francesco Marincola, Global Head of Cell Therapy Research at Kite Therapeutics (owned by Gilead), Dr. Boris Minev, President of Calidi Biotherapeutics, and Dr. Boris Reznik, Chairman of Venvalo Group. Dr. Banerji is a Physician-Scientist with 33 years of Global Development and management experience in Pulmonary Drug Development, has led approvals and launch of 14 FDA approved drugs worldwide in COPD, Asthma and Allergic Rhinitis. Dr. Banerji has published over 100 original articles (The Ultibro story!) in peer reviewed journals (FLAME:NEJM) and over 400 abstracts, with presentations at major International Congress's. Announcement • May 24
Therapeutic Solutions International Receives IND Number 28508 for Chronic Obstructive Pulmonary Disease Clinical Trial and Enters Binding Discussions with FDA for Initiation of Phase I/II Clinical Trial Therapeutic Solutions International announced receiving Investigational New Drug application number #28508 from the United States Food and Drug Administration for its proposed clinical trial evaluating the JadiCell™ in treatment of COPD. The FDA also assigned to the Company a Product name for its investigational biologic now known as “Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection”. Additionally, the FDA has already entered into binding discussions with the Company regarding details of the clinical trial and subject population. The Company previously reported and filed patents on the therapeutic activity of JadiCell in several models ofCOPD, as well as the ability of the cell to inhibit several pathological mechanisms associated with the condition. Currently the Company is running a Phase III clinical trial to treat lung damage in patients with advanced COVID-19. Announcement • May 17
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 05/16/2022, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 13
Therapeutic Solutions International Announces New Data Demonstrating Enhancement of Therapeutic Activities of the Jadicell Therapeutic Solutions International announced new data demonstrating enhancement of therapeutic activities of the JadiCell(TM) through induction of a specific cell type called "Myeloid Derived Progenitor Cells". In a series of experiments, mice were treated with JadiCells, Myeloid Derived Suppressor Cells, and a combination of the two. It was found that the combination possessed superior ability to reduce lung damage and stimulate pulmonary regeneration. Additionally, administration of the FDA cleared drug Leukine was demonstrated to naturally increase levels of Myeloid Derived Suppressor cells and enhance activity of the JadiCells. Announcement • May 10
Therapeutic Solutions International, Inc. Files Investigational New Drug Application Therapeutic Solutions International, Inc. announced filing of an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking permission to treat 10 patients with advanced COPD using its universal donor adult stem cell product termed “JadiCell™”. The Company is currently developing JadiCell as a treatment for COVID-19, for which a Phase III clinical trial has been initiated, as well as for Chronic Traumatic Encephalopathy (CTE), for which the Company has been granted an IND by the U.S. FDA. In previous studies the Company has demonstrated the superior activity of JadiCell to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, in a peer-reviewed publication, the JadiCell was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85. The published study was a report on an FDA double-blinded, randomized, placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%. Announcement • May 03
Therapeutic Solutions International, Inc. Announces Launching of Phase III Clinical Trial for Treating Covid-19 Lung Damage Using its Jadicell Universal Donor Stem Cell Drug Therapeutic Solutions International, Inc. announced the launching of a double-blind, randomized, placebo controlled, multi-center, multi-nation, clinical trial of 128 patients with COVID-19 associated lung failure. The study will be comprised of two groups, JadiCell™ treatment group and control group. The primary endpoint of the study is comparing the proportion of patients alive and free of respiratory failure at Day 60 after treatment with JadiCells as compared to placebo. The Company has licensed the issued patent covering composition of matter for JadiCell and FDA Right of Reference, has identified and filed patents on novel mechanisms of action of JadiCell related to lung preservation and regeneration, and acquired the FDA cleared IND and associated data package, which was the basis for Phase III clearance, and has contracted Biorasi, a global, full-service CRO, to launch and run the clinical trial. In previous studies the Company has demonstrated the superior activity of JadiCell to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind, randomized, placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%. Announcement • Apr 20
Therapeutic Solutions International Identifies Novel Biological Pathway Therapeutic Solutions International announced data demonstrating its JadiCell™ adult stem cell product induces multiplication of specific lung cells which are believed to give rise to new lung tissue which compensate for damaged cells. In a series of experiments, lung injury was induced in mice by administration of inflammatory stimuli representative of bacterial infection, trauma, (TLR-4 agonists) or viral infection (TLR-3 agonists). Intravenous delivery of JadiCells resulted in preservation of lung function and increased multiplication of cells believed to be the “repair cells” of the lung. Importantly, depletion of T regulatory cells negated the therapeutic effects of the JadiCells. The newly announced data supports previous patent filings covering the ability of JadiCell not only to prevent inflammation, cytokine storm, and lung injury, but also to stimulate existing lung stem cells to heal damage that has already occurred. Importantly, the observation that T regulatory cells appear to be essential in stimulation of lung healing suggests the possibility that JadiCells induce a long-term beneficial effect. In contrast to cells of the mesenchymal stem cell family, of which JadiCells are a part of, T regulatory cells have the ability to become memory cells which in many cases persist for life. Announcement • Feb 08
Therapeutic Solutions International Announces Reduction of COVID-19 Associated Cognitive Decline by QuadraMune® Nutraceutical in Animal Model Therapeutic Solutions International announced filing of a new patent covering data demonstrating QuadraMune administration reduces cognitive decline caused by administration of COVID-19 spike protein in mice. In a series of experiments, mice were treated with artificially generated spike protein on a daily basis for 7 days in order to mimic infection with SARS-CoV-2, the virus responsible for COVID-19 disease. One group of mice received saline and two groups received a low and high dose of QuadraMune, a fourth group of mice received no treatment. Significant dose dependent preservation of cognitive activity was observed in mice receiving QuadraMune. Additionally, reduction of microglial activation, a sign of neural inflammation was reported. QuadraMune is an immune modulating nutraceutical whose use in treatment of COVID-19 is covered by issued US Patent #11,229,674. COVID-19 associated brain changes have been shown to cause severe damage in certain individuals. In one recent peer reviewed study, COVID-19 brain pathology was shown to be similar to Alzheimer’s Disease. Announcement • Jan 04
Therapeutic Solutions International Reports Positive Clinical Data on QuadraMune® Reduction of SARS-CoV-2 Spike Protein Induced Inflammation Therapeutic Solutions International announced positive results of a pilot clinical trial in 20 subjects. In the study, ten subjects received placebo and ten received twice daily doses of QuadraMune for seven days. Blood monocytes were extracted and treated with SARS-CoV-2 spike protein in vitro for three time points. A significantly decreased production of the inflammatory cytokine interleukin-6 was reported at all three timepoints. Announcement • Dec 31
Therapeutic Solutions International Successfully Treats No Option Patients with its JadiCell Stem Cell Therapy While Advancing Preparations for Phase III COVID-19 Clinical Trial Therapeutic Solutions International (TSOI) announced successful treatment of 15 recent patients under the Right to Try Law with the Company’s universal donor JadiCell adult stem cell product. All patients displayed no adverse events and demonstrated subjective and objective levels of improvement. There were 12 COVID-19 patients who underwent a profound recovery despite advanced stage of disease, while the retired Navy SEAL that was previously publicly disclosed1 along with two other retired SEALS, had a significant decrease in biomarkers associated with Chronic Traumatic Encephalopathy (CTE), as well as psychological improvement at the two month follow up. Under the Right to Try Law, companies are allowed to provide experimental therapies that have passed Phase I clinical trials to patients who in the opinion of the physician have no therapeutic options available to them. Announcement • Dec 29
Therapeutic Solutions International, Inc. Receives Patent for Cancer and COVID-19 Treatment Therapeutic Solutions International, Inc. announced receipt of a Notice of Allowance from the United States Patent and Trademark Office regarding its patent application entitled “Nutraceuticals for Suppressing Indolamine 2,3 Deoxygenase. To the knowledge of the Company, this is the first issuance of a patent on a nutraceutical supplement for stimulating the immune system by blocking immune suppressive activities used by cancer and viruses in the IDO pathway. The supplement, termed “QuadraMune®” is commercially available on the Company website and through Amazon. Numerous drugs such as Optivo®, Yervoy®, and Keytruda®, have been approved by the FDA for treatment of cancers by boosting immunity though blocking immune inhibiting mechanisms. This class of drugs, called “checkpoint inhibitors” represent a 15.2 billion dollar a year market. The indolamine 2,3 deoxygenase (IDO) pathway is believed to be one of the major immunological checkpoints based on the fact that small molecule blockade of this pathway results in immune mediated destruction of tumors in animals. Announcement • Sep 24
Therapeutic Solutions International, Inc. Discovers and Files Patent on Novel Cellular Therapy Combination for Augmentation of Lung Repair in Covid-19 Model Therapeutic Solutions International, Inc. announced novel data and filing of a patent demonstrating synergistic suppression of lung injury and acceleration of lung regeneration by combining T regulatory cells and JadiCells. In a series of experiments synergistic suppression of lung damage was observed in the endotoxin and Poly (IC) models when umbilical cord blood T regulatory cells were co-administered with JadiCells. Furthermore, blockade of GITR, a member of the TNF receptor superfamily, resulted in suppression of synergy, suggesting a molecular mechanism of this interaction. Lung damage after COVID-19 is believed to be caused by deposition of scar tissue in the functional areas of the lung, which has been quantified to cause dysfunctional breathing for as long as 9 months after infection1. JadiCells, as well as QuadraMune®, a commercially available nutraceutical developed by the Company have been shown to reduce lung scarring in other experiments. Announcement • Sep 14
Therapeutic Solutions International Successfully Treats Veteran Navy Seal Suffering from Chronic Traumatic Encephalopathy with Jadicell™ Adult Stem Cells Under Right to Try Law Therapeutic Solutions International, Inc. announced successful treatment of a United States Navy SEAL Veteran suffering from Chronic Traumatic Encephalopathy (CTE). The patient received 2 injections of the JadiCell adult stem cells, no treatment associated adverse events were noted. The cells were provided under a newly initiated program under which Therapeutic Solutions International provides access to its technologies Pro Bono, to members of the Armed Forces who have defended the United States. CTE is caused by repeated injuries to the brain causing chronic inflammation, deterioration of neuronal communication, and death of brain cells. Announcement • Aug 31
Therapeutic Solutions International, Inc. Files Investigational New Drug Application with FDA for Cancer Blood Vessel Targeting Immunotherapy StemVacs-V to Treat Metastatic Breast Cancer Therapeutic Solutions International, Inc. announced filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate a clinical trial of its StemVacs-V immunotherapy in patients with metastatic breast cancer. On May 24, 2021, the company announced progress in its preclinical experiments supporting the use of the immunotherapy in human trials. Part of the experiments demonstrated superior activity of StemVacs-V to other immune system-based approaches that were cleared by the FDA to literally "choke" tumors to death by blocking their blood supply. Announcement • Aug 24
Therapeutic Solutions International, Inc. Announces Positive Preclinical Results Using Jadicells™ in Animal Model of Chronic Obstructive Pulmonary Failure (COPD) Therapeutic Solutions International, Inc. announced new data and a patent filing covering the use of JadiCells™ and various therapeutic combinations for the treatment of COPD. The experiments involved administration of JadiCells™ intravenously in animals treated with elastase, a protein that elicits deterioration of the lungs in a manner similar to what occurs in COPD. Superior reduction in lung damage was observed in animals receiving JadiCells™ as compared to other clinically used stem cells such as adipose and bone marrow derived mesenchymal stem cells. In addition, JadiCell™ treated animals possessed significantly decreased expression of the inflammatory proteins toll like receptor 4 and increased expression of the anti-inflammatory protein MerTK. In a double blind, placebo controlled clinical trial, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%. Announcement • Aug 12
Therapeutic Solutions International, Inc. Reports Superior Neurogenesis Induction in Animal Model of Viral Induced Cognitive Dysfunction Therapeutic Solutions International, Inc. reported new data and a patent filing describing the superior ability of JadiCell™ adult stem cells to other stem cell types in terms of stimulating production of new brain cells in an animal model of inflammation. The process of producing new brain cells is termed "neurogenesis" and is an active area of research for the company. In previous studies the company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%. Announcement • Aug 10
Therapeutic Solutions International Completes FDA Requested Studies to Initiate JadiCell™ Chronic Traumatic Encephalopathy (CTE) Clinical Trial Therapeutic Solutions International, Inc. announced successful completion of a series of preclinical experiments requested by the United States Food and Drug Administration (FDA) in order to begin Phase I/II clinical trials. The Company, which possesses the only filed Investigational New Drug (IND) application for treatment of chronic traumatic encephalopathy (CTE) was requested by the FDA to perform a series of experiments confirming several of the known properties of the JadiCell™ stem cells. With the completion of these experiments, the Company is cautiously optimistic to be granted clearance to initiate this "first in class" new treatment approach for CTE. CTE is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells. Announcement • Aug 06
Therapeutic Solutions International, Inc. Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy Therapeutic Solutions International, Inc. announced clearance from the Food and Drug Administration (FDA) to initiate a Phase III pivotal trial for registration of the Company's JadiCell™ universal donor stem cell as a treatment for COVID-19 associated lung failure. In previous studies the Company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%. Announcement • Jul 03
Therapeutic Solutions International, Inc. Spin-Off Campbell Neurosciences Initiates Pilot Implementation of Campbell Score™ with California Concierge Medical & Wellness Inc Therapeutic Solutions International, Inc. announced medical implementation of its Campbell Score™ blood-based suicide prediction marker in collaboration with the premiere San Diego personalized health center, Concierge Medical & Wellness Inc. The Campbell Score™ was subject of a clinical trial1 which demonstrated patients with suicidal tendencies have a higher rating on the novel scale2. To the knowledge of the Company, the Campbell Score™ is the only subjective instrument in development capable of assisting psychiatrists in guiding frequency and intensity of their interventions. Announcement • Jul 01
Therapeutic Solutions International Demonstrates Potent Brain Protective Activity of JadiCells in Animal Model of Post-Covid-19 Neurological Damage Therapeutic Solutions International, Inc. announced new preclinical data demonstrating efficacy of its JadiCell Universal Donor stem cell in inhibiting and reversing neuroinflammation induced brain damage in a model representing post-COVID19 infection. In a series of experiments, clinically relevant doses of JadiCell were capable of suppressing astrogliosis, a hallmark of inflammation induced brain damage, as well as reversing memory and cognitive deficits as assessed by the Morris Water Maze and the Modified Barnes Maze test, respectively. The experiments are part of a series of ongoing work in development of the JadiCells as a treatment for post-COVID brain damage. In a double blind, placebo controlled clinical trial, the JadiCell was used to treat 12 patients, while 12 received placebo. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), event-free survival (P = .008), and time to recovery (P = .03). JadiCell infusions were shown safe and could be beneficial in treating subjects with COVID-19 ARDS. Dr. Kesari, together with Board Member Dr. Thomas Ichim and Chief Scientific Officer Dr. Feng Lin recently published the rationale for utilization of mesenchymal stem cells for treatment of COVID-19 lung pathology. Current data suggests that JadiCell possess superior activity to other mesenchymal stem cells in terms of reducing cytokine storm, assisting in pulmonary regeneration, and controlling pathological inflammation. Announcement • Jun 17
Therapeutic Solutions Reports Synergistic Reduction of Schizophrenia in Animal Models Using Low Dose Naltrexone and T Regulatory Cell Stimulation Therapeutic Solutions International, Inc. reported new data validating claims in its previously filed patent application demonstrating potent synergy between low dose naltrexone and agents stimulating T regulatory cells. In one set of experiments, interleukin-2, an FDA cleared cancer immunotherapy drug is combined with low dose naltrexone to potently reduce schizophrenic-like behavior in an animal model of the condition. Naltrexone is a medication approved by the Food and Drug Administration (FDA) to treat both opioid use disorder and alcohol use disorder as a medication-assisted treatment option. Studies also showed that low dose naltrexone synergizes with mesenchymal stem cells and myeloid suppressor cells, both cell types are capable of inducing the generation of T regulatory cells in vivo. Announcement • Jun 08
Therapeutic Solutions International Reports Amplification of Cancer Specific Immune Responses Using Second Generation Tumor Endothelial Targeting Vaccine StemVacs-V iPSC Therapeutic Solutions International, Inc. reported potent synergy between its tumor blood vessel targeting StemVacs-V iPSC immunotherapy and several classical tumor specific therapeutic vaccines. In a series of experiments tumor growth administration of dead tumor cells together with StemVacs-V resulted in potent immunological memory to the tumor cells, which could be transferred to immunologically naïve mice. Additionally, the experiments demonstrated killing tumor cells using conventional approaches such as chemotherapy, when performed together with StemVacs-V iPSC, led to the development of immunological memory towards the specific cancer. Despite cancer immunotherapy being an over 100 billion dollar a year market in 2020, most cancers still do not respond to this approach. These are called "cold tumors." It is believed that by starving the cancer of its blood supply, StemVacs-V iPSC may convert cold tumors to immunotherapy sensitive "hot tumors". Announcement • Jun 03
Therapeutic Solutions International Subsidiary Campbell Neurosciences Identifies T Regulatory Cells as Mechanism of Stem Cell Suppression of Schizophrenia Pathology in an Animal Model Therapeutic Solutions International, Inc. reported a series of experiments, covered by its >1000 claim patent application filed in September 2020, which demonstrate stem cell activity against schizophrenia is associated with T regulatory cell induction. The experiments demonstrated that mice, which responded to stem cell therapy possessed increased levels of anti-inflammatory cytokines interleukin-4 and interleukin-10, as well as augmented levels of cells expressing FoxP3, a marker characteristic of T regulatory cells. Depletion of T regulatory cells was capable of reducing some of the symptoms of schizophrenia in mice. Announcement • May 25
Therapeutic Solutions International, Inc. Announces New Data Demonstrating Synergy Between its Tumor Blood Vessel Killing Vaccine, StemVacs-V iPSC and Specific Immunological Adjuvants Therapeutic Solutions International, Inc. announced new data demonstrating synergy between the Company's tumor blood vessel killing vaccine, StemVacs-V iPSC and specific immunological adjuvants. The data is part of a package being developed that the Company will send to the Food and Drug Administration (FDA) as part of its planning for an Investigational New Drug (IND) filing. Additionally, the data was incorporated in a patent application filed. StemVacs-V iPSC is a cellular product generated from a standardized inducible pluripotent stem cell (iPSC) which is differentiated into cells that resemble blood vessels which feed the tumor. Additionally, StemVacs-V iPSC expresses the alpha1,3-galactosyltransferase gene which causes the cells to express to Gal alpha 1-3Gal beta-4-GlcNAc (alpha Gal). Announcement • May 22
Therapeutic Solutions International, Inc. Develops Novel Stem Cell Based Therapy to Reduce Lung Scarring: Potential Solution to Post COVID-19 Lung Deterioration Therapeutic Solutions International, Inc. announced new data and patent filing demonstrating that the FDA cleared drug, lithium carbonate, substantially augments the scar inhibiting activity of its licensed JadiCell™ universal donor stem cell therapy. Furthermore, the data reveals that the JadiCell™ was superior to other stem cells at inhibiting development of lung scarring in the bleomycin model of pulmonary fibrosis. The use of JadiCells for treatment of lung pathology and COVID-19 is exclusively licensed and owned by Therapeutic Solutions International. In an FDA double blind, placebo controlled clinical trial the JadiCell™ was successful at substantially improving survival in end-stage patients with COVID-19 associated acute lung failure. Specifically, treatment was associated with significantly improved patient survival (91% vs 42%, P =0.015), Serious Adverse Event-free survival (P =0.008), and time to recovery (P =0.03). The Company plans to initiate a phase III pivotal registration trial and seek marketing approval for use of JadiCell in acute respiratory distress syndrome (ARDS) and other lung diseases. Announcement • May 18
Therapeutic Solutions International and Campbell Neurosciences Announce Preclinical Studies Showing Low Doses of FDA Cleared Immune Stimulant Interleukin-2 Reduces Inflammation Associated Depression in Animal Model Therapeutic Solutions International, Inc. announced preclinical data utilizing low doses of the FDA cleared therapeutic interleukin-2 in treatment of inflammation induced depression in an animal model. The experiments, which are covered in a patent application, demonstrate that low doses of interleukin-2 reduce depressive behavior, which is dependent on a newly identified cellular mechanism. Given that interleukin-2 at higher doses is approved by the FDA for treatment of melanoma and renal cell cancer, the Company believes that clinical development of this novel approach to depression may possess less regulatory hurdles than other product candidates. Campbell Neurosciences recently announced validation in a clinical trial of its "Campbell Score™" a blood-based test capable of assessing suicidal ideations in a quantitative manner. Announcement • Apr 27
Therapeutic Solutions International, Inc. Reports Regression of Established Tumors by Combining its Cancer Blood Vessel Targeting Immunotherapy with Low Dose Chemotherapy Therapeutic Solutions International, Inc. announced new data demonstrating an unexpected synergy between its inducible pluripotent stem cell (StemVacs-V iPSC) derived immunotherapy product with low dose cyclophosphamide in evoking potent immune mediated cancer regression. In a series of experiments, the Company demonstrated that its previously announced stem cell derived tumor endothelial-like cell vaccine enabled non-toxic doses of cyclophosphamide, an established chemotherapeutic agent, to induce significant reduction of established lung cancers, brain cancers, and skin cancers in animal models. Furthermore, it was demonstrated that reduction of tumors was associated with increased infiltration of immune cells. Announcement • Apr 02
Therapeutic Solutions International, Inc. announced delayed annual 10-K filing On 03/31/2021, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Mar 17
Therapeutic Solutions International Announces Novel Cancer-Resistant iPSC-Derived Dendritic Cell Immunotherapy: StemVacs-V™ Therapeutic Solutions International, Inc. announced filing of a patent and new data covering what the company believes to be the first gene-modified, stem cell derived, universal donor dendritic cell cancer immunotherapy. The novel product, StemVacs-V™, is derived from a gene-modified stem cell which is designed to express proteins found selectively in cancer such as the antigen Brother of the Regulatory of Imprinted Sites. Additionally, the stem cell is gene silenced for receptors which cancer generally uses to block immune cell activation. Once the stem cells are made into dendritic cells, the resulting product is an immunotherapy that: Activates the immune system to selectively kill cancer, without toxicity; and is resistant to cancer-induced immune suppressive activities; and Can be generated in an economical, reproducible, and consistent manner. The company previously treated 10 cancer patients using StemVacs dendritic cells and demonstrating augmentation of natural killer cell activity. The company now aims to clinically develop StemVacs-V™, which is an iPSC-derived dendritic cell that is specifically engineered to attack cancer. The BORIS antigen, which was utilized by the company in preclinical studies has been demonstrated by scientists at the National Institutes of Health, together with company Board Member, Dr. Thomas Ichim, to function as a "universal cancer vaccine”. The data disclosed in the filed patent application demonstrate that dendritic cells generated from iPSC cells expressing the BORIS antigen can induce regression of B16 melanoma, and that when the dendritic cells were generated from iPSC cells gene silenced for VEGF-receptor, a significantly stronger anti-tumor response was observed. Announcement • Mar 05
Therapeutic Solutions International, Inc. Spin-off Campbell Neurosciences Announces Umbilical Cord Derived Monocyte Immunotherapy Candidate for Suicide Prevention Therapeutic Solutions International, Inc. announced preclinical results and filing of a patent covering the use of manipulated cord blood derived monocytes for prevention of suicidal ideations as well as inflammation of the brain. Company scientists found that administration of non-stem cell components of cord blood to mice exposed to brain inflammation resulted in protection of neurological function as well as suppression of immunological proteins associated in humans with suicidal thoughts. Paradoxically, it was found that the monocyte component of cord blood was associated with therapeutic activity. Monocytes are typically inflammation inducing cells. Through a trial and error process, the Company found oxytocin pretreatment under proprietary conditions resulted in protection of neurological function (Morris Water Maze) and reduction of inflammation in preclinical studies. Announcement • Mar 04
Therapeutic Solutions International Approves on RangeMe to sell QuadraMune™ and NanoStilbene™ Along with Other Supplements Therapeutic Solutions International, Inc. announced the approval to market the dietary supplements on the RangeMe B2B platform. The initial products to be offered will be NanoStilbeneä, ProJuvenolä, QuadraMuneä and NanoPSA. As new products are commercialized, they will be added to this initial offering of these four, the most popular supplements. Announcement • Feb 26
Therapeutic Solutions International Spin-Off Campbell Neurosciences Demonstrates Preliminary Efficacy of First Blood-Based Test for Gambling Addiction: Kaihani Score™ Therapeutic Solutions International, Inc. announced positive preliminary data from its ongoing Federally Registered clinical trial entitled "Validation of Kaihani Score for Gambling Addiction1". Preliminary data revealed a profound increase in the neuromodulatory protein assessed by Kaihani Score™ which correlated with gambling addiction severity. Four patients with no gambling addiction had 13.4±1.6 ng/ml, four patients with moderate gambling addiction had 37.4±5.6 ng/ml, and four patients with several gambling addiction had 57.7±6.3 ng/ml. Severity of gambling addiction was assessed using Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS). The clinical study needs to recruit another 6 patients per group for completion. Announcement • Feb 23
Therapeutic Solutions International Uses Stemvacs™ Platform to Generate Personalized Adoptive T Cell Therapy Targeting Cancer Stem Cells Therapeutic Solutions International, Inc. reported novel data and filing of a patent application demonstrating that StemVacs™ cells carrying proprietary sequences from the cancer-specific antigen Brother of the Regulator of Imprinted Sites (BORIS), were able to elicit the generation of T cells capable of selectively killing cancer stem cells. In contrast to other markers associated with cancer, BORIS is not simply a "flag" that is recognized by the immune system, but it is essential for cancer to be cancer. Dr. Thomas Ichim, Board Member of the Company, published that gene silencing of BORIS resulted in the death of cancer cells.1 National Institutes of Health Scientist Dr. Dmitri Loukinov, as well as other collaborators, published with Dr. Ichim that DNA immunization with BORIS resulted in suppression of aggressive breast cancer,2 as well as induction of T cells capable of killing glioma, leukemia, and mastocytoma. Researchers believe current cancer treatments sometimes fail because they don't destroy the cancer stem cells. Think of cancer as a weed: the stem cells are the root while the remaining majority of the cells are the part of the weed above ground. If remove only the leaves but not the root, the weed will grow back. The same is true for cancer: if do not kill the cancer stem cells, the cancer is likely to return. Announcement • Feb 18
Therapeutic Solutions International Appoints Dr. Boris Minev to Scientific Advisory Board Therapeutic Solutions International, Inc. announced appointment of Dr. Boris Minev to the Scientific Advisory Board of the Company. Dr. Minev joins other internationally renowned tumor immunologists including Dr. Francesco Marincola, Dr. Santosh Kesari, and Dr. Feng Lin. Dr. Boris Minev is currently the President of Medical and Scientific Affairs at Calidi Biotherapeutics, Inc. in San Diego, CA. Dr. Minev has a stellar track record of successes in the area of cancer immunotherapy, being a developer of Melacine® the first tumor vaccine to obtain regulatory approval. He held a position as the Director of Immunotherapy and Translational Oncology at Genelux Corporation, where he was directing several preclinical and translational projects on oncolytic virotherapy, immunotherapy, and nanotechnology. Dr. Minev is also an adjunct professor at the Moores UCSD Cancer Center. There, he served previously as Principal Investigator and Director, Laboratory of Tumor Immunology and Immunotherapy, for more than 15 years. Prior to that, Dr. Minev worked in Dr. Steven Rosenberg's Tumor Immunology Section at the Surgery Branch of the National Cancer Institute. Announcement • Feb 09
Therapeutic Solutions International Reports Preliminary Data Suggesting StemVacs Induces Natural Killer Memory to Cancer Therapeutic Solutions International, Inc. announced filing of a new patent application with data demonstrating that mice immunized with StemVacs possesses a type of memory natural killer cells which are capable of transferring immunity to naïve mice. Typically, the concept of immunological memory applies only to cells of the adaptive immune system such as T cells and B cells, but not to natural killer cells, which are considered part of innate immunity. In a series of experiments, mice bearing B16 melanoma were treated with StemVacs, which induced regression and eventual disappearance of the tumor. One month after disappearance of the tumor, mice were sacrificed, and NK cells were transferred to mice that were not treated with StemVacs. The mice receiving NK cells were resistant to development of melanoma upon challenge. Although substantial survival in some patients has been achieved with immunotherapeutics called checkpoint inhibitors, the majority of tumors do not respond because the tumors are considered cold, meaning there is little immune recognition. The company believes that StemVacs, by stimulating natural killer cells to attack cancer, may possess the ability to turn cold tumors into hot, thereby making them susceptible to killing by the adaptive immune system. Announcement • Feb 05
Therapeutic Solutions International Enters into Master Sales Agreement with Community Shield LLC Therapeutic Solutions International, Inc. announced the signing of a Master Sales Agreement with Community Shield LLC of Sheridan Wyoming to distribute its science-based nutraceutical line of products. Products to be included in the Master SalesAgreement currently consists of QuadraMune™, NanoStilbene™, NeuroStilbene, NanoPSA, Nano Plus, Nano Cannabidiol, and ProJuvenol®. Future products will be added to Master List as commercialized and provide same levels of discount. Announcement • Jan 28
Therapeutic Solutions International, Inc. Announces Filing of Patent Disclosing Enhancement of Natural Killer Cell and T Cell Activity by Stemvacs After Treatment with Homotaurine, A Safe Blood-Brain Barrier Permeable Gaba A-R-Specific Agonist Therapeutic Solutions International, Inc. announced filing of a patent disclosing enhancement of natural killer cell and T cell activity by StemVacs after treatment with homotaurine, a safe blood-brain barrier permeable GABA A-R-specific agonist. The data suggests the possibility that neurologically acting molecules, such as homotaurine, may be an unexplored area for discovery of novel immune modulators. Announcement • Jan 26
Therapeutic Solutions International Reports Regression of Glioma, Lung Cancer and Colorectal Cancer using StemVacs in Animal Models Therapeutic Solutions International, Inc. announced expansion of its preclinical dataset on StemVacs, an umbilical cord generated dendritic cell immunotherapy. In a series of laboratory experiments, StemVacs administration was demonstrated to induce regression of GL261 glioma, CT-26 colorectal cancer, and Lewis Lung Carcinoma tumors grown in mice. Company reported that StemVacs administration effectively reduces breast cancer through immune stimulation in a natural killer cell dependent manner1. Mechanistically, regression in glioma, colorectal and lung cancer was also dependent on mice possessing a functional natural killer cells repertoire. Dendritic cells are usually utilized in an autologous manner, meaning they are generated from the same person that they are used upon. Technologies developed by Therapeutic Solutions International allow for the manufacture of unique dendritic cells from cord blood stem cells, which can be used in a universal donor manner. Announcement • Jan 20
Therapeutic Solutions International Reports Successful Treatment of Breast Cancer Using StemVacs Cellular Immunotherapy Therapeutic Solutions International, Inc., reported positive animal data in the 4T1 breast cancer model using its clinically tested StemVacs cellular immunotherapy. In a series of experiments, it was demonstrated that StemVacs administration resulted in a) regression of established breast cancer in mice; b) that regression was dependent on natural killer cells, and c) that immunity to breast cancer could be transferred by CD4 T cells to nave mice. Previously the Company announced positive safety data in 10 patients treated with StemVacs™. Additionally, the Company has filed an Investigational New Drug Application (IND) which is currently pending based on the Company responding to questions posed by the FDA. Announcement • Jan 14
Therapeutic Solutions International Announces Positive Early Clinical Data from Ongoing Suicidal Ideation Blood Biomarker Clinical Trial with Spinoff Campbell Neurosciences Therapeutic Solutions International, Inc. announced positive preliminary data from the Federally listed clinical trial "Correlation of Campbell Score with Suicidal Ideation.". From a group of four healthy controls and four patients with suicidal ideations, the patients with suicidal ideations possessed approximately 3-fold higher levels of the inflammatory cytokine as compared to controls (24.2 ± 7.7 pg/ml vs 8.4 ±2.9 pg/ml). The clinical trial is planned to recruit an additional 22 patients and aims to establish validity of the Campbell Score™ as an objective marker to quantify risk of suicide. The Campbell Score™ is currently being developed by Campbell Neurosciences, a partially-owned spinoff of Therapeutic Solutions International. Announcement • Jan 06
Therapeutic Solutions International Reports QuadraMune Administration Enhances T Cytotoxic Responses in Mouse Model of Adaptive Immunity Therapeutic Solutions International, Inc. reported new data from its ongoing investigations into the immunological mechanisms by which QuadraMune functions as a potential antiviral nutraceutical. In mice receiving QuadraMune for a period of two weeks, a significantly increased cytotoxic T cell response was seen after immunization with proteins that resemble virally associated proteins. T cytotoxic cells are a component of the immune system which selectively kills virally infected cells. Successful immunity to viruses is dependent on T cytotoxic cell activity. Announcement • Dec 31
Therapeutic Solutions International, Inc. Reports QuadraMune Increases T Cell Immunity in Animal Studies Therapeutic Solutions International, Inc., reported new data demonstrating a two-week course of QuadraMune increased immunological parameters relevant to antiviral immunity. In a series of experiments, the Company demonstrated that animals injected with a model antigen, keyhole limpet hemacyanin possessed a significantly enhanced T cell response. The type of T cell response that was preferentially elicited in animals taking QuadraMune was associated with interferon gamma, a protein known to inhibit viral replication. The Company is currently running a clinical trial in health care workers using QuadraMune to prevent COVID-19 infection. More information on the clinical trial can be found on the Federal Clinical Trials registry as #NCT04421391. Announcement • Dec 19
Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell® Universal Donor Stem Cell Therapeutic Solutions International, Inc. announced filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells. The JadiCell is a type of umbilical cord derived mesenchymal stem cell which possesses superior therapeutic activity as compared to other stem cell types based on laboratory and clinical studies. The JadiCell was
recently reported to possess therapeutic activity against COVID-19 in a recently published clinical trial. The Company previously obtained an exclusive license for use of JadiCells for CTE and Traumatic Brain Injury (TBI). Chronic Traumatic Encephalopathy (CTE) is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells. Announcement • Nov 18
Therapeutic Solutions International, Inc. announced delayed 10-Q filing On 11/17/2020, Therapeutic Solutions International, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Nov 11
Therapeutic Solutions International, Inc. Reports Augmentation of Immunotherapy Efficacy in Breast Cancer Model Utilizing Patented NanoStilbene Nutraceutical Product Therapeutics Solution International, Inc. announced novel data supporting utilization of the Company's NanoStilbene product for enhancement of cancer immunotherapy clinical trials. In the experiments disclosed November 10, 2020, Company collaborators injected mice with a type of breast cancer termed 4T1. This aggressive type of cancer, which represents triple negative breast cancer, was demonstrated to have a reduced level of growth when treated with a type of immune stimulatory drug which represents a mouse version of Yervoy. The combination of NanoStilbene with Yervoy leads to not only inhibition of tumor growth, but actual regression. Yervoy is approved by the FDA for treating several types of cancers including melanoma. Its sales in 2018 where 1.3 billion dollars. The Company believes patients responding to Yervoy may be increased by combining with NanoStilbene. Announcement • Oct 30
Therapeutic Solutions International Launches Clinical Trial to Validate First Blood Based Predicator of Suicidal Ideation: The Campbell Score Therapeutics Solution International, Inc. announced publication on the NIH clinical trials website of its newly initiated trial aiming to validate a blood-based diagnostic for predicting suicide risk. The Campbell Score, which is a patent-pending method of quantifying inflammatory-associated biological markers, has previously been shown in pilot investigator-initiated studies to correlate with propensity for suicide. Based on positive feedback from collaborators, the Company decided to initiate a formal clinical trial to validate correlations between the Campbell Score and established psychiatric assessment tools of suicidal propensity. Currently the only means of quantifying predisposition to suicide is based on psychological, question-based techniques. These tests are highly subjective and biased based on desire of questionee to avoid being labeled as crazy. Therapeutic Solutions International has previously filed patents for diagnosing people at high risk of suicide and intervening using immunotherapy and stem cell based approaches. 