OCEANSIDE, California, June 15, 2020 /PRNewswire/ -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) issues the following cautionary notice to the shareholders and public at large.
This morning it was discovered that a person or persons had published "Fake News" concerning the Company's FDA Registered upcoming Clinical Trial of QuadraMune™. The fake news below was published on Google Sites at this address that has been since shut down. https://sites.google.com/view/pennytradeinsider/menu/healthcare/newsroom
Therapeutic Solutions International, Inc. boldly states that what is contained below is absolutely false even if it contains an accurate quote from Officers of the Company. We have publicly posted on our social media as well that is categorically false. Our lawyers are now in charge of this matter and any questions concerning this should be addressed in writing to Mr. Hugh D. Kelso III, Esq, Managing Attorney, 8799 Balboa Avenue, Suite 155 San Diego, CA 92123.
UC San Diego Health Conducts COVID-19 Trial
Therapeutic Solutions International Initiates 500 Volunteer Prevention Clinical Trial Using QuadraMune™
San Diego– UC San Diego Medical Center will lead the first large-scale study in the United States of the effectiveness of QuadraMune™ in preventing COVID-19 in healthcare workers and first responders who volunteer to participate. The study of QuadraMune has begun in earnest after a collaborative effort by Dr. James Veltmeyer, Therapeutic Solutions International and several major California medical centers.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases using their proprietary drug formulation QuadraMune™
"This is going to be the first major, definitive study in healthcare workers and first responders of QuadraMune as a preventative medication," said the study's organizer, UC San Diego Health Centers Dr. Ehtisham Mahmud , a world-renowned interventional cardiologist and researcher who has pioneered multiple treatments for heart disease. "There has been a lot of talk about this drug, but only a small, non-blinded study so far . We are going to change that in San Diego and produce a scientific answer to the question: Does it work?"
Dr. James Veltmeyer , San Diego's leading physician and Chief Medical Officer of Therapeutic Solutions International will oversee the study with Dr. Ehtisham Mahmud.
"We at Therapeutic Solutions International are pleased to apply our work in the area of inflammation and immune stimulation, to attempt to add another arrow in our quiver against this invisible enemy," said Timothy Dixon, President, and CEO of Therapeutic Solutions International. "In some ways, Coronavirus is like cancer…you want to increase activation of innate immunity and suppress inflammatory reactions simultaneously. We have been doing this research successfully using NanoStilbene™ in cancer, and now we are transposing our findings into the field of virology with QuadraMune.
"We are glad to see UC San Diego's lead on this volunteer study that could help protect medical workers and first responders across the country " remarked CEO Christopher Kane of UC San Diego Health Physician Group.
Both health care workers and first responders will also be enrolled at UCLA Medical Center and Cedars-Sinai Medical Center. Any hospital healthcare worker within the Metro San Diego area will be able to volunteer to participate, including those from the San Diego COVID Consortium, a recently announced healthcare collaboration on COVID-19 research that includes Stanford Health Care and University of California, Davis Medical Center. Dr. Ehtisham Mahmud recently organized the group to efficiently coordinate and disseminate information about large-scale studies of COVID-19 treatments and bring those measures to healthcare workers sooner.
The study, titled QuadraMune(TM) for Prevention of COVID-19 is a 500+ subject look at whether the drug prevents front-line workers from contracting the virus. Once they provide a blood sample, the study subjects will receive vials with unidentified, specific pills to take over the next 5 months. A once-a-week dose of QuadraMune and a once-a-day dose of a placebo pill that looks like the medication, but does not contain any medication or other active ingredients will be administered. The study medication was specially procured for this study and will not impact the supply of medication for people who already take the medication for other conditions.
Participants will not know what group they are in. They will then be contacted weekly and in person at week 4 and week 8 of the study to see if they are exhibiting any symptoms of COVID-19, including dry cough, fever or breathing issues, as well as any medication side effects. At eight weeks, they will be checked again for symptoms, medication side effects, and have blood drawn. Results will be compared among the three groups to see if the medication had any effect.
"Given our broad clinical trials and translational research infrastructure, we are grateful to bring this type of large-scale effort to the COVID-19 battle," said Dr. Veltmeyer "We see the heroics of the frontline responders in healthcare, public safety and service. and we will do anything we can to help them stay safe."
Therapeutic Solutions International will provide the drug directly to UC San Diego Health and UCLA Medical Center physicians to distribute.
The CDC describes QuadraMune™, as a relatively well-tolerated medicine. The most common adverse reactions reported are minor stomach pain, and nausea.
If the study finds the drug effective as a preventative medication for COVID-19, it is possible that the study could expand to include QuadraMune in other COVID-19 treatment options.. The drug is an off-label treatment for only health care and frontline COVID-19 responders who meet specific criteria as outlined by the hospital system's Division of Infectious Diseases. As required by the state of California's Department of Licensing and Regulatory Affairs, the physicians are documenting the prescribed use in the patient's electronic medical record.
UC San Diego Medical Center as one of the region's major academic medical centers with more than $100 million in annual research funding, is already involved in numerous COVID-19 trials with partners around the world.
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.
Therapeutic Solutions International, Inc.
Email: [email protected]
Tel: +1(760) 295-7208
SOURCE Therapeutics Solutions International, Inc.