TSOI Receives Allowance on Patent Claim from the US Patent Office Covering ProJuvenol® Active Ingredient Pterostilbene in Cancer Immunotherapies

February 06, 2017 08:30 ET

Company Developing Proprietary Nutraceutical ProJuvenol® to Augment FDA Approved Drugs
that Help Immune System Fight Cancer

OCEANSIDE, CA –(Marketwired – February 06, 2017) – Therapeutics Solutions International, Inc., (OTC PINK: TSOI) announced today that the United States Patent and Trademark Office allowed issuance of a claim covering the combination of pterostilbene, the active ingredient in its ProJuvenol® product, together with an FDA-approved immunotherapeutic drug named Proleukin® (aldesleukin), which is a recombinant form of the cytokine interleukin-2 (IL-2) for treatment of cancer.

Proleukin® is one of the first immunotherapeutic drugs approved by the FDA, being indicated for treatment of metastatic melanoma and metastatic renal cell carcinoma1. Scientists working with Therapeutic Solutions International performed animal studies showing that administration of pterostilbene increased efficacy of Proleukin® in melanoma models. In the studies performed to obtain FDA approval for Proleukin® responses were seen in 16% of patients2. Based on animal data, it is hoped that the response rate of Proleukin® can be increased by administration of products containing pterostilbene, such as ProJuvenol®.

“It is important to understand that the immune system does not work in isolation. The findings by Therapeutic Solutions International that immune killing of cancer can be augmented by nutritional modification supports relatively easy to implement approaches that may have an impact on patient survival,” said Santosh Kesari, MD, Ph.D., member of the Company’s Scientific Advisory Board. Dr. Kesari is also the Chair of Translational Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute and the Pacific Neuroscience Institute.

Immuno-Oncology, described by Science Magazine as ‘Breakthrough of the Year3‘ offers the possibility of not only killing tumor cells in a non-toxic manner, but also establishing immunological memory, which patrols the body and destroys recurrent tumor cells. While great progress has been made in developing drugs that stimulate the immune system to recognize and kill tumors, a major pitfall of current approaches is that tumors produce chemicals and oxidative stress that suppresses the immune system, thus limiting efficacy of immune therapies. The unique properties of pterostilbene are believed to be useful in overcoming factors used by the cancer to protect itself from the immune system. Independent scientific studies have shown that pterostilbene, which is chemically related to resveratrol, has been published to possess anticancer4,5, antioxidant6, and anti-inflammatory activities7.

“We are confident that this validation of our science by the United States Patent and Trademark Office, combined with our ongoing basic and applied research efforts will help offer patients non-toxic means of augmenting existing drugs that work by modulating the immune system,” said Timothy Dixon, President and CEO of Therapeutic Solutions International.

About Therapeutic Solutions International, Inc.
The Company’s corporate website is www.therapeuticsolutionsint.com. Our new products can be viewed on www.projuvenol.com and products can be ordered at www.youcanordernow.com.

These Supplement products have not been evaluated by the United States Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any diseases.

Safe Harbor Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our SEC filings. To the extent that statements in this press release are not strictly historical, including statements as to product launch timing, revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future collaboration agreements, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.

1 https://www.proleukin.com/health-care-professional/

2 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
ApprovalApplications/TherapeuticBiologicApplications/ucm094495.pdf

3 Couzin-Frankel J. Breakthrough of the year 2013. Cancer immunotherapy. Science. 2013;342:1432-3. https://www.sciencemag.org/content/342/6165/1432.summary

4 Yang et al. Pterostilbene exerts antitumor activity via the Notch1 signaling pathway in human lung adenocarcinoma cells. PLoS One. 2013 May 3;8(5):e62652. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3643961/

5 Li et al. Pterostilbene acts through metastasis-associated protein 1 to inhibit tumor growth, progression and metastasis in prostate cancer. PLoS One. 2013;8(3):e57542. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3586048/

6 McCormack and McFadden. A review of pterostilbene antioxidant activity and disease modification. Oxid Med Cell Longev. 2013;2013:575482. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3649683/

7 Qureshi et al. Inhibition of nitric oxide and inflammatory cytokines in LPS-stimulated murine macrophages by resveratrol, a potent proteasome inhibitor. Lipids Health Dis. 2012 Jul 10;11:76. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3393619/