We have had a whirlwind of a year in discovery and amazement at TSOI and we are optimistic for the coming year. I thought I would address just some of the major accomplishments this year brought.
In May of this year, President Donald J. Trump signed into law the “Right To Try” Act and TSOI responded by announcing we would move to offer our immunotherapy platform “StemVacs”. We were also honored to appoint Dr. James Veltmeyer as Chief Medical Officer to head up all of our RTT programs.
During the spring and summer, we conducted two small studies of NanoStilbene, our nanoparticle pterostilbene product. One was a pharmacokinetic study comparing NanoStilbene (a liquid form) with traditional powder form pterostilbene. We took two groups of healthy volunteers and gave one group 300 milligrams (mg) in capsule form and the other group 10 milliliters of NanoStilbene which also contains 300mg of nanoparticle pterostilbene and studied their blood across time. We were pleased to see that compared to powder, NanoStilbene at peak blood concentration was 55% greater than the powder form at its peak, and even more pleased at the half-life being double of powder.
In a second clinical study of NanoStilbene in advanced cancer patients, we sought to determine whether administration of our nanoparticle formulation of pterostilbene may reverse cancer associated suppression of NK cell (natural killer cell) activity. We concluded that study mid-summer using the same dose as was used pharmacokinetically and we are currently preparing to submit our manuscript for publication in a medical journal validating NanoStilbene as an adjuvant to chemo and immunotherapy.
We also filed 3 additional provisional patent applications on the use of pterostilbene during the summer. These were a direct result of the data that came back from our advanced cancer study. One of those patents is for Car-T Cell sickness or Cytokine Release Syndrome. Car-T is one of the most advanced FDA approved immunotherapies on the market. Our data from the cancer study supports the use of NanoStilbene to suppress the cytokine storm of Car-T sickness.
We were also greatly honored when Wes Chandler of NFL fame brought to our attention Chronic Traumatic Encephalopathy or CTE, a condition that affects sports players and others who receive repetitive concussions and head injuries. We quickly formed a CTE advisory board with Wes as Chairman to explore CTE and have since filed two CTE related patents. One for prevention of CTE we call NeuroStilbene and one for therapeutic treatment of CTE with enhanced stem cells.
Next on the CTE project was to find a cellular product that would qualify under “Right To Try” and we found that product in the form of mesenchymal stem cells. On Dec 10 we announced licensing of the Jadi Cell universal donor adult stem cell for use in Chronic Traumatic Encephalopathy (CTE), and Traumatic Brain Injury (TBI). Our intent is to have these cells available in early 2019 under RTT.
I know there are many moving parts at TSOI and some of it is years away like the 9,682,047 patent was in July 2015 when we filed, but here we are wrapping up 2018 with a human validated and a patent granted product, NanoStilbene. Looking to 2019 the key things you will see from us will be the promotion of NanoStilbene and NeuroStilbene and the “Right To Try” use of stem cells and eventually our dendritic cell vaccine for cancer, StemVacs.
A Special Thank You to my science and medical team for all of their hard work this past year and for the hard work left ahead of us that they are committed to. We are looking forward to 2019 as an important year for TSOI and we thank all of you for your patience and wish you a Happy New Year from everyone at TSOI. For a more detailed release visit us on www.facebook.com/tsoihome/
Tim G Dixon, President & CEO
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 www.therapeuticsolutionsint.com.
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.
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