Therapeutic Solutions International Inc (OTCMKTS: TSOI) is an exciting stock in small caps currently running up the charts quickly attracting legions of shareholders and emerging as a volume leader in penny stocks. Investors are accumulating as the Company is is preparing to conduct a clinical trial aimed at demonstrating safety and efficacy of its immune-boosting formulation QuadraMune™, The trial is anticipated to recruit 500 subjects at risk of SARS-CoV-2 infection, the type of coronavirus which causes COVID-19.
TSOI got another boost after the Company reported it has filed a new patent application with the USPTO covering the use of QuadraMune and type 2 diabetes med metformin to treat coronavirus COVID-19 associated lung damage.
Therapeutic Solutions International Inc (OTCMKTS: TSOI is a pink reporting Company out of Oceanside, California. The Company has been 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.
In May TSOI quietly announced the filing of 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.
QuadraMune consists of four unique ingredients that in tandem provide synergism in reducing inflammation. Tim Dixon CEO of TSOI and the co-inventor of the QuadraMune patent stated “We have of course included pterostilbene, a very potent inhibitor of inflammatory molecules, along with sulforaphane, a phase II detox promoter which also protects lungs from damage by activating the Nrf2 gene, EGCg (epigallocatechin gallate), extracted from green tea that can stimulate T cells, inhibit pathological immunity, and also protect the lungs, and thymoquinone which comes from the plant nigella sativa that suppresses autophagy, potential antiviral mechanistic effects on cells, and has been demonstrated to stimulate NK cells which are antiviral.”
In early June TSOI initiated a clinical trial aimed at demonstrating safety and efficacy of its immune-boosting formulation QuadraMune™. The trial is anticipated to recruit 500 subjects at risk of SARS-CoV-2 infection, the type of coronavirus which causes COVID-19. The new clinical trial has been granted ClinicalTrials.gov Identifier: NCT04421391 and is expected to appear on the Federal Clinical Trial registry this week.
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This came after the Company reported data from a preliminary clinical trial in which four groups of eight volunteers were treated with placebo or escalating doses of QuadraMune™. Elevation of innate immune response activity was observed, together with a decreased responsiveness towards inflammatory stimuli. These preliminary data were analyzed by the Company’s Scientific Advisory Board, who then recommended proceeding to the larger trial. The clinical trial calls for the daily administration of QuadraMune™ for a period of twelve weeks. Rates of infection will be assessed compared to controls. Subjects eligible to enter the trial are high-risk individuals, which are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.
TSOI got another push after the Company announced the filing of a patent showing potent synergy between QuadraMune™ and the antidiabetic drug metformin in treating COVID-19 associated lung damage models. It was discovered that the ability of QuadraMune™ to protect the lungs from inflammation that resembles coronavirus-induced pathology is markedly amplified by concurrent administration of metformin. At a mechanistic level, it was shown that metformin increased the ability of QuadraMune™ to: a) increase the number of “healing macrophages” (“M2” macrophages); b) augment production of anti-inflammatory and regenerative proteins; and c) suppress production of pathological inflammatory proteins.
“We are currently preparing to conduct a 500-person study evaluating protection from COVID-19 in individuals at high risk of infection, which is listed on the NIH website1,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “In light of the current findings, we are extremely interested in evaluating outcomes in patients already taking metformin, which is one of the commonly used drugs in elderly populations.”
$TSOI's QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. https://t.co/yaFiaEFpvU
— TherapeuticSolutions (@TSOIsupplement) July 9, 2020
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Currently running up the charts TSOI is is pink reporting Company out of Oceanside, California. TSOI is an exciting story developing in small caps; the Compnay is preparing to conduct a clinical trial aimed at demonstrating safety and efficacy of its immune-boosting formulation QuadraMune™, The trial is anticipated to recruit 500 subjects at risk of SARS-CoV-2 infection, the type of coronavirus which causes COVID-19. The new clinical trial has been granted ClinicalTrials.gov Identifier: NCT04421391. In a preliminary clinical trial performed by TSI in which four groups of eight volunteers were treated with placebo or escalating doses of QuadraMune™. Elevation of innate immune response activity was observed, together with a decreased responsiveness towards inflammatory stimuli. TSI has the right people behind it; its Chief Medical Officer Dr. James Veltmeyer is not only a brilliant Doctor but also has political connections. 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.