THERAPEUTIC SLTNS INTL - TSOI STOCK NEWS

Therapeutic Solutions International (OTC-PINK:TSOI) announced a patent filing covering gene silencing for treating Acute Respiratory Distress Syndrome (ARDS), a significant cause of mortality. The company is conducting a Phase III trial for COVID-19 induced ARDS, seeking FDA approval to include ARDS from other causes. New data shows a 70% reduction in mortality in treated mice, indicating a survival advantage. The company aims to accelerate the development of this and other respiratory therapeutics.

Therapeutic Solutions International has submitted an amendment to the FDA for its Phase III clinical trial, expanding eligibility for patients with Acute Respiratory Distress Syndrome (ARDS) to include all causes, not just those related to COVID-19. This expansion aims to address a significant market opportunity, as ARDS cases in the U.S. reach approximately 200,000 annually, with no current curative options. The company believes this move will accelerate the trial's completion and increase patient access to JadiCell, a promising treatment.

Therapeutic Solutions International (OTC-PINK: TSOI) announced promising findings from its research on the ApoptoCyte™ procedure, which showed superior efficacy in treating Chronic Obstructive Pulmonary Disease (COPD) with its JadiCell™ product. In comparative studies, the ApoptoCyte-treated JadiCell exhibited the highest therapeutic activity against COPD in an animal model. The company is preparing for a Phase III clinical trial for COPD treatment, leveraging existing IND #28508, and aims to address significant unmet medical needs in this area.

Therapeutic Solutions International announced advancements in creating second-generation, tailor-made cellular therapies using gene-edited regenerative cells. These cells blend the properties of mesenchymal stem cells with immune tolerance capabilities, enhancing their specificity for various diseases. The Company is focusing on a Phase III clinical trial of JadiCells for COVID-19 ARDS while also advancing its intellectual property on disease-specific iPSC modifications. Key figures include iPSC cells that are 3-5 times more effective at liver regeneration in specific models.

Therapeutic Solutions International has received Emergency IND #28685 and a “May Proceed Notification” from the FDA for advanced COVID-19 ARDS treatment, facilitating the use of JadiCells for patients outside of a Phase III trial. The company previously treated 15 no-option patients under eIND and Right to Try laws. CMO Dr. James Veltmeyer emphasized the urgent need for these therapies, especially with rising COVID-19 cases. The JadiCell, currently in Phase III, has shown superior activity compared to other stem cell therapies and is also being developed for COPD and other conditions.

Therapeutic Solutions International announced validation of its QuadraMune™ nutraceutical after a research report from John Hopkins Children's Center in Nature Communications Biology demonstrated that sulforaphane, an ingredient in QuadraMune™, suppresses SARS-CoV-2 activity. The findings suggest further exploration of sulforaphane for treating coronavirus infections. The company holds two US Patents related to QuadraMune™ and its efficacy in immune modulation and coronavirus treatment. QuadraMune™ is available commercially on platforms like Amazon and Walmart.

Therapeutic Solutions International announced the appointment of Dr. Donald Banerji to its Scientific Advisory Board. Dr. Banerji, a leader in respiratory medicine with over 33 years of experience, will provide guidance as the company advances its Phase III clinical trial for COVID-19 and has filed an Investigational New Drug Application for Chronic Obstructive Pulmonary Disease (COPD). CEO Timothy Dixon highlighted Dr. Banerji's extensive expertise in the development of drugs for respiratory conditions as crucial for the company's transition to a clinical-stage organization.

Therapeutic Solutions International has received FDA Investigational New Drug application #28508 for its JadiCell in treating COPD. The FDA assigned a product name, 'Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection,' and discussions are underway regarding the trial details. Dr. James Veltmeyer highlighted promising animal data and previous clinical recoveries. The company is currently conducting a Phase III trial for lung damage due to advanced COVID-19, aiming for impactful treatment options in the COPD space.

Therapeutic Solutions International announced advancements in its COPD program alongside a pivotal COVID-19 clinical trial. New data reveals that combining JadiCell™ with Myeloid Derived Suppressor Cells enhances therapeutic efficacy, reducing lung damage and encouraging pulmonary regeneration. The FDA-cleared drug Leukine was also shown to boost Myeloid Derived Suppressor cell levels, improving JadiCell activity. The company has filed an Investigational New Drug application for JadiCells in COPD treatment and is exploring collaborations with immunotherapy stakeholders.