Todos Medical to Present Final Data from the Tollovir Phase 2 Clinical Trial in Hospitalized COVID-19 Patients at the Personalized Medicine World Conference

Rhea-AI Summary

Todos Medical (OTCQB: TOMDF) announced its subsidiary 3CL Pharma will present final data from the Phase 2 clinical trial of Tollovir™ for treating severe COVID-19 patients at the PMWC on June 30, 2022. The trial's primary endpoint showed 100% improvement in patients treated with Tollovir, compared to 66% in the placebo group, with 0% mortality versus 22% in placebo. The forthcoming biomarker data aims to elucidate Tollovir's mechanism of action, supporting its development for severe COVID-19 and Long COVID treatment.

Positive

• 100% of patients treated with Tollovir showed clinical benefit during therapy.
• Tollovir demonstrated 0% mortality in treated patients compared to 22% in placebo.
• Final biomarker data presentation will clarify Tollovir's mechanism of action.

Negative

• None.

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 majority-owned subsidiary 3CL Pharma will present final data from the phase 2 clinical trial of Tollovir™ in the treatment of hospitalized (severe and critical) COVID-19 patients at the Personalized Medicine World Conference (PMWC) on June 30th, 2022 at 1:30pm Pacific Time.   

“While the Company announced positive topline clinical results from this trial in late January earlier this year, it became clear that the final dataset with the biomarker data and other key clinical data results were going to be critical to allow the market to understand the full impact that Tollovir™ could have on the standard care in treatment of hospitalized patients and are critical to inform the Phase 2/3 clinical trial design, especially with recent clinical development advances in the field where competing products saw mortality rates upwards of 20% in treated groups,” said Gerald Commissiong, CEO of Todos Medical. “The clinical results of Tollovir, especially the primary endpoint of improvement while on therapy as measured by the National Early Warning System 2 rating scale (NEWS2), in which Tollovir showed 100% of patients achieving clinical benefit as measured compared with 66% in the placebo arm, and in which the Tollovir group showed 0% mortality while on therapy vs 22% mortality in the placebo arm, were key outcomes the market did not fully comprehend. The value of the additional forthcoming biomarker data that we will announce at this conference is that it will tie the underlying biological Tollovir mechanism of action with the clinical trial outcome to further underscore the strength of Tollovir’s impact on hospitalized COVID-19. Validating the hypothesized mechanism of action, and being able to now better describe how it works, will further support for our forthcoming Phase 2/3 development program for Tollovir in hospitalized COVID-19 patients, as well as provide a strong basis for the use of Tollovir in the treatment of Long COVID.”  

About Tollovid® and Tollovid Daily™
Tollovid and Tollovid Daily are 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.

About Tollovir®
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 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 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.

For more information, please visit https://www.todosmedical.com/.

Forward-looking Statements
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.

Todos Corporate Contact:
Daniel Hirsch
CFO
Todos Medical
917-983-4229 x 104
Dan.h@todosmedical.com

Todos Investor Relations Contact:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com

FAQ

What are the clinical results of Tollovir in the Phase 2 trial?

In the Phase 2 trial, Tollovir showed 100% improvement while on therapy, contrasting with a 66% improvement in the placebo group, and recorded 0% mortality versus 22% in the placebo group.

When will Todos Medical present the final data for Tollovir?

Todos Medical will present the final data for Tollovir at the Personalized Medicine World Conference on June 30, 2022.

What is the significance of the biomarker data for Tollovir?

The biomarker data will help clarify Tollovir's mechanism of action and enhance understanding of its clinical trial outcomes, supporting future Phase 2/3 development.

What is the primary focus of Todos Medical's clinical development?

Todos Medical focuses on developing Tollovir for treating severe COVID-19, moderate COVID-19, Long COVID, and potentially pediatric COVID-19.

What is the impact of Tollovir on the COVID-19 treatment landscape?

Tollovir's results indicate potential to significantly improve outcomes for hospitalized COVID-19 patients, especially given competing products with higher mortality rates.