Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned subsidiary 3CL Pharma, Ltd. has received an Institutional Review Board (IRB) waiver to initiate a market research study to gather and evaluate consumer feedback regarding the use of the Company’s 3CL protease inhibitor immune support dietary supplement products Tollovid® and Tollovid Daily™ in their COVID and Long COVID (aka Post-Acute Sequalae of SARS-CoV-2, or “PASC”) journeys. The objective of the study will be to determine whether there is sufficient real-world evidence to support a potential product development program for Tollovid and/or Tollovid Daily in the treatment of Acute COVID and/or Long COVID. Tollovid and Tollovid Daily are not approved to diagnose, treat, prevent or cure any disease, including COVID and/or Long COVID. In the weeks ahead, the Company will be contacting customers electronically to complete surveys prepared by our team of physician-scientists to help guide our next steps.
Concurrent with this announcement, the Company announced that it will be offering a 50% discount on the price of Tollovid Maximum Strength through close of business on May 31st, 2022.
“In the last year we have heard anecdotal reports from customers who have experienced great success using our dietary supplements,” said Gerald E. Commissiong, President and CEO of Todos Medical. “These reports eventually piqued the curiosity of physicians who successfully used our products to help patients, with two such successful Long COVID case studies having been made public and several others in various stages of completion. Based on these, we are preparing for an observational study for Tollovid in Long COVID, and have received overwhelming interest from physicians and patients in participating. This surprising level of interest was the impetus behind accelerating our data gathering efforts by starting the assessment of Tollovid and Tollovid Daily in our existing customer base to determine whether the reviews and anecdotal reports we have heard from clients are in fact part of a more significant pattern of activity that could be codified using Good Clinical Practice (GCP) standards so that the data could be shared with regulators.”
Mr. Commissiong continued, “Listening to customers is a core business principal, which allowed us to realize that we were attracting many solution-seekers willing to try our products if we improved the affordability to help them overcome that barrier. In the short run this could affect our profit margins which are currently being used to re-invest in research & development for botanical drug Tollovir® in the treatment of hospitalized COVID-19, and Videssa® for the early detection of breast cancer. However, we felt it was more important to immediately increase access to the Tollovid Maximum Strength product. Our strategy is to increase total profit through additional sales volume, and our marketing team recently linked an uptick in sales to the Long COVID physician case studies, including international interest. If successful, aspects of these temporary moves could become permanent and allow us to accelerate investment into critical research so that we can drive these important products to market faster, because what we will lose in per bottle profit will be more than gained in overall sales volume. As a research driven company, we take great care to carefully quality control our products. We look forward to engaging with our customers in the weeks ahead to gather key data that could further drive our push to bring forward solutions for customers and patients.”
About Tollovid® and Tollovid Daily™
Tollovid and Tollovid Daily are a dietary supplement products made from natural ingredients that help support and maintain healthy immune function and also have potent 3CL protease inhibition properties based upon in vitro functional assays that show strong inhibition of 3CL protease activity. Tollovid’s 3CL protease IC50 binding affinity is at least ten times (10x) as strong as Ivermectin’s published 3CL protease IC50 binding affinity. Tollovid Daily’s 3CL protease IC50 binding affinity is at least two and a half times (2.5x) as Ivermectin. Tollovid and Tollovid Daily bind to the active site (receptor binding domain) of the 3CL protease. Tollovid has a 5-day dosing regimen, with 4 doses of 3 pills taken each day that provides maximum immune support. Tollovid Daily is a daily immune support product with a dosing regimen of twice daily.
Tollovir® is a 3CL protease inhibitor and anti-cytokine therapeutic candidate for the treatment of the nidovirus subcategory of coronaviruses that includes SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and 229E. Tollovir is made from all natural ingredients that are qualified to ensure strong inhibition of the 3CL protease in vitro, as well as strong anti-cytokine activity. Tollovir is currently in a Phase 2 clinical trial in Israel for the treatment of patients hospitalized with COVID-19. Tollovir will be developed for the treatment of hospitalized COVID-19 (severe and critical), moderate COVID-19, long-haul COVID and potentially pediatric COVID-19. Todos has licensed rights for Tollovir to T-Cell Protect Hellas S.A. for the Greek market.
About Todos Medical Ltd.
Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers’ life-saving diagnostic solutions for the early detection of a variety of cancers. The Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2 have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista’s proprietary commercial-stage Videssa® breast cancer blood test.
Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses.