Todos Medical Announces Positive Biomarker Data from Phase 2 Trial of Tollovir in Hospitalized COVID-19 Patients
§ Biomarker data correlates with clinical data announced in January 2022
§ 46 patient open label extension being opened to support US FDA EUA application
New York, NY, and Tel Aviv, ISRAEL, June 30, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced biomarker data from its majority-owned joint venture 3CL Pharma Ltd.’s Phase 2 clinical trial of Tollovir™ in hospitalized COVID-19 patients. The data showed a positive correlation between the clinical data announced for Tollovir on January 27, 2022 and biomarkers associated with acute phase immune response (IL-6), inflammation (C reactive protein), blood clotting (D-dimer) and immune response to COVID-19 (cPass neutralizing antibodies). Additionally, renal and hepatic biomarker data showed no signals of treatment-associated risk with Tollovir therapy.
“We are very pleased to have confirmed that all the key biomarker endpoints IL-6, CRP, D-Dimer and cPass neutralizing antibodies correlate with the improved clinical outcomes associated with Tollovir treatment,” said Dr. Dorit Arad, co-founder of 3CL Pharma. “With these data in hand, we plan to reproduce the findings in a slightly larger patient population as part of the open label extension. Once we complete our recruitment of a handful more patients, we will be able to present our data package to regulatory authorities worldwide regarding the benefit of Tollovid therapy in addition to standard of care versus standard of care alone.”
Recent peer reviewed literature shows the predictability of key biomarker data such as IL-6, CRP, and D-Dimer in the hospitalized setting. The existence of these studies allows us to focus resources on recruiting just active patients.
“We believe the correlative biomarker data, in addition to the positive clinical results previously reported in hospitalized patients primarily from the Delta variant wave, should elevate Tollovir’s profile in the eyes of regulators,” said Gerald Commissiong, President & CEO of Todos Medical and Interim-CEO of 3CL Pharma. “After review with our regulatory attorneys, we believe that if additional data from our planned open label extension of the study (N up to 46, all to receive Tollovir) are consistent with the data from the blinded, placebo-controlled trial segment (N = 20 in Part 2), we will apply for an Emergency Use Authorization (EUA) in the United States and Europe. Given that the extension is open label, we will be able to look at the data on an ongoing basis as we interact with regulators and submit data as they become available. Initiating the extension study in the very near future is our priority, as BA.5-related hospitalizations at our primary clinical trial site at Shaare Zedek Medical Center in Jerusalem, Israel have increased over 1400% in the last 3 weeks. The data gathered from this BA.5 wave will be a compelling part of the EUA submission to the US Food & Drug Administration and European Medicines Agency.”
Tollovir® is an oral 3CL protease inhibitor and anti-cytokine therapeutic candidate for the intervention of the Nidovirus group of viruses that includes coronaviruses such as 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 has successfully completed 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 Tollovid® and Tollovid Daily™
Tollovid and Tollovid Daily are oral 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. Preliminary data from an ongoing IRB-waiver study of customers who used the products to assist with their COVID and Long COVID was recently announced.
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 examines 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 formed the Israeli-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of the intellectual property pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitor botanical and pharmaceutical products that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid® in the United States, is developing the dual mechanism 3CL protease inhibitor & anti-cytokine therapeutic drug candidate Tollovir®, while also developing the 3CL protease inhibitor diagnostic TolloTest™.
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 only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related 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 funding 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 launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; 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; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from the competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any 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 unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
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