New York, NY, and Tel Aviv, ISRAEL, May 27, 2022 (GLOBE NEWSWIRE) — via NewMediaWire —Todos Medical, Ltd. (OTCQB: TOMDF)a comprehensive medical diagnostics and related solutions company, today announced that its majority subsidiary 3CL Pharma will present final data from the Phase 2 clinical trial of Tollvir™ in the treatment of hospitalized patients (severe and critical) with COVID-19 at the Center for Personalized Medicine World Conference (PMWC) on June 30, 2022 at 1:30 p.m. Pacific Time.
“As the company announced the first positive clinical results from this trial in late January earlier this year, it became clear that the final dataset with biomarker data and other key clinical data results were going to be essential to enable the market to understand the full impact that Tollvir™ could have on standard care in the treatment of hospitalized patients and are essential to inform the design of the phase 2/3 clinical trial, in particular with the recent advances in the clinical development in the field where competing products have seen mortality rates greater than 20% in treated groups,” said Gerald Commissiong, CEO of Todos Medical. “The clinical results of Tollovir, particularly the primary endpoint of improvement during treatment, as measured by the National Early Warning System Rating Scale 2 (NEWS2), in which Tollovir has mo nted that 100% of patients achieve clinical benefit as measured compared to 66% in the placebo arm, and in which the Tollovir group showed 0% mortality during treatment compared to 22% mortality in the placebo arm, were key findings that the market has not fully understood. The value of the additional upcoming biomarker data that we will be announcing at this conference is that it will link the underlying biological mechanism of action of Tollvir to the clinical trial results to further underscore the strength of the impact of Tollvir on hospitalized COVID-19. Validation of the hypothesized mechanism of action and the ability to better describe how it works will further support our upcoming Phase 2/3 development program for Tollvir in hospitalized patients with COVID-19, and provide a solid foundation for the use of Tollovir in the treatment of Long COVID.
About Tollovid® and Tollovid Daily™
Tollovid and Tollovid Daily are dietary supplements made from natural ingredients that help support and maintain healthy immune function and also have potent 3CL protease inhibiting properties based on in vitro functional tests that show strong inhibition of 3CL protease activity. Tollovid’s IC50 3CL protease binding affinity is at least ten times (10x) higher than the IC50 3CL protease binding affinity published by Ivermectin. The IC50 binding affinity of Tollovid Daily’s 3CL protease is at least two and a half times (2.5x) that of 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 which provides maximum immune support. Tollovid Daily is a daily immune support product with a twice daily dosing schedule.
Tollovir® is a 3CL protease inhibitor and anti-cytokine therapeutic candidate for the treatment of the nidovirus subcategory of coronaviruses which includes SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and the 229E. Tollvir is made from natural ingredients qualified to provide strong 3CL protease inhibition in vitro, as well as strong anti-cytokine activity. Tollovir has successfully completed a Phase 2 clinical trial in Israel for the treatment of patients hospitalized with COVID-19. Tollvir 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 the rights of Tollvir to T-Cell Protect Hellas SA for the Greek market.
About Todos Medical Ltd.
Founded in Rehovot, Israel, with offices in New York, Todos Medical Ltd. (OTCQB: TOMDF) designs life-saving diagnostic solutions for the early detection of various cancers. The company’s advanced and patented Biochemical Infrared Assays (TBIAs) are a proprietary cancer screening technology using peripheral blood analysis that deploys an in-depth examination of cancer’s influence on the immune system, looking for biochemical changes in blood and plasma mononuclear cells. The two cancer screening tests developed in-house by Todos, TMB-1 and TMB-2, have received CE marking in Europe. Todos recently acquired US medical diagnostics company Provista Diagnostics, Inc. to obtain the rights to its CLIA/CAP-certified laboratory based in Alpharetta, Georgia, which currently performs COVID PCR tests and the breast cancer screening blood test. Videssa® exclusive to Provista at the commercial stage.
Todos also develops 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 (PBL) and monocytes to resist exogenous mitogenic stimulation that prompts them to enter the cell cycle. Some diseases, including Alzheimer’s disease, are thought to be the result of compromised cellular machinery that leads to aberrant cell cycle reentry by neurons, which then leads to apoptosis. LymPro is unique in using peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and brain neurons.
Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover several international suppliers of PCR test kits and related equipment and supplies, as well as antibody test kits from several manufacturers after completing validation of said test kits and supplies at its CLIA/CAP certified partner laboratory in 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.
For more information, please visit https://www.todosmedical.com/.
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based solely on the current expectations of management and are subject to important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including risks and uncertainties relating to the progress , timing, cost and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional financing required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in the initiation of our clinical trials; changes in legislation; failure to develop and introduce new technologies, products and applications on a timely basis; lack of validation of our technology as we progress and lack of acceptance of our methods by the scientific community; the inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; cost of final product higher than expected; loss of market share and pressure on prices resulting from competition; and laboratory results that do not translate into equally good results under actual conditions, which could cause actual results or performance to differ materially from those contemplated by such forward-looking statements. Except as otherwise required by law, Todos Medical undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please see its reports filed from time to time with the United States Securities and Exchange Commission.
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