Therapeutic Solutions International Universal Donor Immunotherapy StemVacs™ Activates Antiviral Immune Cells While Protecting Lungs From "Cytokine Storm"

Preclinical Experiments for Upcoming FDA Submission Reveal Possible Dual Benefit in COVID-19 Model

OCEANSIDE, CA -- June 30, 2020 -- InvestorsHub NewsWire -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) announced today new data and a patent filing showing its clinical-stage cancer immunotherapeutic product StemVacs™ appears to reduce innate immune induced inflammation in lungs while stimulating immune cells known to possess antiviral properties.

StemVacs™ is a cell-based drug comprised of dendritic cells activated in a proprietary manner which when administered stimulates a type of immune system cell termed "natural killer" or NK cells.  Numerous studies have shown that NK cells are involved in protecting the body from cancer and from viruses. The FDA has allowed for clinical trials of COVID-19 patients using an NK cell-based drug termed CYNK-001 [1]. 

Immune therapy of COVID-19 patients has been considered by some as a double-edged sword.  On the one hand, it is desirable to augment immune responses to control the virus, on the other hand, excessive immunity is known to lead to acute respiratory distress syndrome (ARDS), which is a major cause of death. The current animal data sought to replicate the lungs of patients suffering from ARDS by treating mice with a potent activator of the innate immune system molecule TLR4.  To the surprise of Company scientist's administration of StemVacs™ actually reduced the lung inflammation.

"Given the established safety profile of StemVacs™ from our previous studies, as well as the findings reported today, we are on track for advancing towards FDA interactions," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "To my knowledge, the majority of immunotherapies have the potential to cause lung inflammation through what is called "cytokine storm". It may be that StemVacs, operates through novel molecular mechanisms due to our unique methods of preparing the cells."

In contrast to traditional dendritic cell-based immunotherapies, StemVacs™ can be administered without the need for matching donor to recipient, allowing for standardized manufacturing.  Additionally, StemVacs™ preparation involves "forcing" the dendritic cells to mature by treatment with leukocyte derived extracts, which appears to induce higher expression of immune-stimulatory molecules as compared to standard approaches.

"We are pleased with the rapid progress in the development of data and scientific rationale for utilization of StemVacs™ for COVID-19 clinical trials," said Timothy Dixon, President, and CEO of the Company. "Our philosophy at TSOI is that the body knows best how to defend itself.  Our job is to just give it support to help the immune system do what it naturally does.  We are doing this in our QuadraMune™ clinical trial and with StemVacs™ we hope to do the same thing."

About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. Immune modulation refers to the ability to upregulate (make more active) or downregulate (make less active) one's immune system. The Company's corporate website is at www.therapeuticsolutionsint.com and our e-commerce is at www.youcanordernow.com and for additional info on QuadraMune visit www.areyoucovidmune.com/covidmune/.

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

[1] https://www.prnewswire.com/news-releases/celularity-announces-fda-clearance-of-ind-application-for-cynk-001-in-coronavirus-first-in-cellular-therapy-301034141.html

Therapeutic Solutions International, Inc.
ir@tsoimail.com

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