QuadraMune™ Synergizes with Metformin to Stimulate Anti-Viral Defenses in Pilot Clinical Trial

OCEANSIDE, Calif., Nov. 24, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported today clinical trial data demonstrating significant increases in natural killer cell activity in 12 healthy volunteers receiving daily QuadraMune™ as compared to controls taking placebo. 

Using a standard test for natural killer cell activity, the K562 lysis assay, 12 healthy volunteers taking one week of placebo had an average activity of 2.3 (±0.6), whereas those taking one week of QuadraMune™ had an average activity of 5.2 (±1.2), almost double.  Twelve diabetics taking the diabetes drugs metformin had an activity of 2.7 (±1.1), while 12 diabetics taking metformin and QuadraMune™ had 10.4 (±3.5).

"These data have profound implications for our ongoing clinical trial assessing QuadraMune™ for prevention of COVID-19 in health care workers," said Famela Ramos, Vice President of Business Development for the Company. "It is well established that natural killer cell activity is the first barrier to viral infections such as COVID-19¹,²,³,⁴.  In fact, clinical trials are currently ongoing using natural killer cells for treatment of COVID-19 ⁵,⁶.  This potent synergy between QuadraMune™ and metformin imply possibility of using this combination not only for treatment of COVID-19 but also other indications which respond to natural killer cells such as cancer and other viruses."

The Company previously reported that QuadraMune™ together with metformin potently reduced lung inflammation in an animal model of COVID-19 ⁷.  Additionally, QuadraMune™ was shown to reduce myeloid suppressor cells ⁸, a type of cell which is upregulated in COVID-19 patients and suppresses immunity towards SARS-CoV-2 ⁹.  

"During the current pandemic, it is my honor to work on developing scientific data to elucidate mechanisms of action of QuadraMune™, which in my opinion will lead to novel weapons in our war against this invisible enemy," said Wais Kaihani, collaborator to the Company and co-inventor on a patent filed covering utilization of QuadraMune™ as a stimulator of NK cell activity and synergies with metformin.

"Through collaborating with science-oriented basic and clinical collaborators, we are blessed to rapidly obtain mechanistic data on QuadraMune™, which to our knowledge is the only nutraceutical in clinical trials which appears to concurrently induce activation of specific antiviral immune cells while reducing lung inflammation," said Timothy Dixon, President and CEO of the Company. "Obviously the study is preliminary in nature and the fact that we are comparing diabetics to healthy volunteers presents an undesirable variable.  That said, the potent increase in natural killer cell activity both without and with metformin strongly suggests continuation of mechanistic studies and disease inhibiting studies for treatment and/or prevention of SARS-CoV-2 infection and progression to COVID-19."

About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/ and Campbell Neurosciences at https://www.campbellneurosciences.com.

¹ Duijf. Baseline pulmonary levels of CD8+ T cells and NK cells inversely correlate with expression of the SARS-CoV-2 entry receptor ACE2. bioRxiv. 2020 May 5;2020.05.04.075291
² Fathi et al. Immune system changes during COVID-19 recovery play key role in determining disease severity. Int J Immunopathol Pharmacol. Jan-Dec 2020;34
³ Dujif. Low Baseline Pulmonary Levels of Cytotoxic Lymphocytes as a Predisposing Risk Factor for Severe COVID-19. mSystems. 2020 Sep 1;5(5):e00741-20
⁴ Bortolotti et al. SARS-CoV-2 Spike 1 Protein Controls Natural Killer Cell Activation via the HLA-E/NKG2A Pathway. Cells. 2020 Aug 26;9(9):1975.
⁵ https://www.clinicaltrials.gov/ct2/show/NCT04324996  
⁶ https://www.clinicaltrials.gov/ct2/show/NCT04365101  
⁷ https://www.biospace.com/article/releases/therapeutic-solutions-international-reports-unexpected-findings-of-synergy-between-quadramune-and-diabetes-drug-metformin-in-animal-models-of-covid-19-lung-damage/
⁸ https://www.biospace.com/article/releases/therapeutic-solutions-international-reports-quadramune-reduces-myeloid-suppressor-cells-in-4t1-mouse-model-of-breast-cancer/
⁹ Agrati et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Cell Death Differ. 2020 Nov;27(11):3196-3207.


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