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Monday, October 18, 2021

Therapeutic Solutions International Inc (OTCMKTS: TSOI) Major Breakout as Biotech Sleeper Files Emergency Use Authorization (EUA) earlier this week to the FDA for JadiCells™

Therapeutic Solutions International Inc (OTCMKTS: TSOI) is making an explosive move up the charts in recent days after the Company initiated the preparation for filing an Emergency Use Authorization (EUA) earlier this week to the FDA for JadiCells™ in treatment of COVID-19 associated lung injury.  The EUA is a mechanism that allows FDA to help strengthen the nation’s public health protections against threats such as infectious diseases by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.  

Microcapdaily first reported on TSOI on June 22, 2020 when the stock was trading for well under the $0.01 mark as the Company first got into the covid game quietly announced the filing of a patent application covering QuadraMune™. Since than the Company has made serious haedway in the space recently trading at high as $0.175. Currently on a powerful breakout and under heavyu accumulation TSOI is emerging as one of the most talked about stocks in small caps with a huge international following trading over $10 million in dolalr volume on Friday alone. A break over $0.175 and its blue skies ahead for TSOI. 

Therapeutic Solutions International Inc (OTCMKTS: TSOI) operating out of Oceanside, California. is focused on immune modulation for the treatment of several specific diseases. Activating one’s immune system is now an accepted method to cure certain cancers, reduce recovery time from viral or bacterial infections and to prevent illness. Additionally, inhibiting one’s immune system is vital for reducing inflammation, autoimmune disorders and allergic reactions. TSI is developing a range of immune-modulatory agents to target certain cancers, improve maternal and fetal health, fight periodontal disease, and for daily health. 

TSOI forray into covid treatement started in May of last year when the Company filed a patent application covering QuadraMune™, a nutraceutical developed to address issues of susceptibility, inflammation, and viral immunity, for COVID-19 patients. Initial work on QuadraMune™ was based on patent application 62/735867, filed Sept 25, 2018, which disclosed uses of pterostilbene to treat cytokine release syndrome in a variety of conditions including severe acute respiratory syndrome (SARS) and acute respiratory distress syndrome (ARDS).  Furthermore, issued patent #9,682,047 described the use of pterostilbene to decrease neutrophil activation in cancer patients. 

TSOI licsensed the Jadi Cell universal donor adult stem cell back in 2018, as covered in US Patent No.: 9,803,176 B2 for use in Chronic Traumatic Encephalopathy (CTE), and Traumatic Brain Injury (TBI). The Jadi Cell product, which belongs to the mesenchymal stem cell (MSC) family of cells, is a unique adult stem cell, which produces higher levels of therapeutic factors compared to other stem cells.  The cells have demonstrated safety in animal models and pilot human trials. 

In December the Company filed for 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 trial1. The Company previously obtained an exclusive license for use of JadiCells for CTE and Traumatic Brain Injury (TBI)2,3. 

Since than the Company has demonstrated in a number of studies the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, in an FDA double blind clinical trial the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 ICU patients1 under the age of 85. On August 5th, 2021, the FDA granted clearance for initiation of a Phase III pivotal trial using JadiCells to treat COVID-192. The extremely promising preclinical data the Company is generating, as well as the previously published double blind FDA clinical trial and most recently, FDA clearance to enter Phase III, strongly supports the rationale to file for Emergency Use Authorization. 

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The Company has been beefing up its leadership team at this important time bringing on Pharmaceutical Industry Veteran  Dr. Boris Reznik to Accelerate Value Optimization of FDA Cleared Phase III COVID JadiCell™ Clinical Trial. Boris Reznik is the Chairman of Venvalo Group, a venture value optimization firm. During his career, Dr. Reznik founded and built technology companies into market leaders and successfully dealt with both Fortune 500 and emerging companies as clients and partners. He has been a lead or co-investor in startups and mid-market firms and has participated in M&A transactions ranging from Millions to Billions.  

TSOI also brought on Peter C Farrell, PhD, DSc, AM to the Advisory Board of its Spin-Off Company Campbell Neurosciences. Dr. Farrell is the founder and chairman of the board of ResMed (RMD), a NYSE traded company that changes lives with medical devices and cutting-edge cloud-based software applications that better diagnose, treat and manage sleep apnea, chronic obstructive pulmonary disease (COPD) and other chronic diseases. Dr. Farrell also is Chairman of Arcturus, Inc. (ARCT), a NASDAQ-listed leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases.   

Campbell Neurosciences is focused on approaching suicide as a biological disorder and has recently reported positive results on the ability of its in-licensed patent pending blood-based Campbell Score® to predict suicidal ideations1. 

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TSOI is making an explosive move up the charts in recent days after the Company initiated the preparation for filing an Emergency Use Authorization (EUA) earlier this week to the FDA for JadiCells™ in treatment of COVID-19 associated lung injury.  The EUA is a mechanism that allows FDA to help strengthen the nation’s public health protections against threats such as infectious diseases by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.  Microcapdaily first reported on TSOI on June 22, 2020 when the stock was trading for well under the $0.01 mark as the Company first got into the covid game quietly announced the filing of a patent application covering QuadraMune™. Since than the Company has made serious haedway in the space recently trading at high as $0.175. Currently on a powerful breakout and under heavyu accumulation TSOI is emerging as one of the most talked about stocks in small caps with a huge international following trading over $10 million in dolalr volume on Friday alone.. A break over $0.175 and its blue skies ahead for TSOI. We will be updating on TSOI when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with TSOI.

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Disclosure: we hold no position in TSOI either long or short and we have not been compensated for this article.

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