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Todos Medical Announces All 31 Patients Enrolled to Date in Tollovir Phase 2 Clinical Trial in Hospitalized COVID-19 Patients Have Completed Study Participation

  • Dr. Jules Mitchel now leading preparation for data lock and statistical analysis

Tel Aviv - (NewMediaWire) - December 02, 2021 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, together with its 3CL biology-focused joint venture partner NLC Pharma, today announced that all 31 patients enrolled to date in Tollovir® Phase 2 clinical trial in hospitalized COVID-19 patients have completed study participation and the data are now being entered into the database for analysis. Dr. Jules Mitchel, a strategic advisor retained by Todos to assist with the analysis, is now leading preparation for data lock and statistical analysis. The Company expects data analysis to be completed in December 2021.

The management team of Todos Medical, including Mr. Gerald E. Commissiong, President and Chief Executive Officer, will host a conference call today, December 2nd at 4:30 p.m. EST to discuss the Company’s business progress in 2021 and provide a strategic outlook for the future.

The call information is as follows:

·       Date:  December 2, 2021

·       Time:  4:30 p.m. Eastern Standard Time

·       Direct Dial-in number: (669) 900-6833

·       Meeting ID: 94945983568

·       Passcode: 167897

This call is being webcast and can be accessed at https://audience.mysequire.com/webinar-view?webinar_id=6b97aec0-7ccb-4754-9a33-5c26d34d9597.

The call will also be available for replay by accessing https://audience.mysequire.com/webinar-view?webinar_id=6b97aec0-7ccb-4754-9a33-5c26d34d9597.

For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.

About Dr. Dorit Arad

Dr. Dorit Arad is a D.C. in physical organic chemistry from the Technion who has more than 25 years of experience in the life science industry as an international researcher, executive and entrepreneur. Dr. Arad is a pioneer in the discovery and development of 3CL protease biology related products and product candidates. Dr. Dorit Arad is an interdisciplinary scientist with expertise in Computer assisted Drug Design, Biotechnology, mechanism-based drug design, Diagnostics, infectious disease and cancer. 

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 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 TolloTest®

TolloTest® is a 3CL protease diagnostic fluorescence platform technology that has demonstrated clinical proof of concept in hospital setting and outpatient settings in correctly identifying patients infected with COVID-19, including within 1-3 days of first exposure. TolloTest diagnostic tools are being developed to address key deficiencies with current SARS-CoV-2 rapid antigen and PCR technologies. TolloTest can provide results in less than ten (10) minutes, and potentially in as little as two (2) minutes. Data generated from two studies conducted with TolloTest demonstrate that: (1) it can identify SARS-CoV-2 infected patients earlier than rapid antigen testing (potentially earlier than PCR testing), (2) it can identify patients who are likely no longer infectious, but still test positive by PCR and (3) it can identify patients that are still likely infectious, but who have been released from quarantine based on time from positive PCR test. TolloTest assay formats are being developed for (1) point-of-care/at-home market and (2) rapid mass screening in community settings (airports, schools, offices).

About Tollovid® & Tollovid Daily™

Tollovid and Tollovid Daily are dietary supplement products, made from natural ingredients, that help support and maintain healthy immune function, and are also 3CL protease inhibitor products based upon in vitro functional assays that show inhibition of 3CL protease activity. Tollovid's 3CL protease inhibition activity release criteria is at least twice as stringent as Tollovid Daily's 3CL protease inhibition release criteria. 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 twice daily immune support product that is designed to provide ongoing daily immune support for the person on the go.

About T-Cell Protect Hellas S.A.

T-Cell Protect Hellas (www.tcellprotect.com), based in Athens, Greece, is a European nutraceutical manufacturer and supplier of immune support dietary supplement products that is led by a world-class management team. The company has a retail distribution network of over 11,000 stores throughout Greece. Mr. Filippopoulos, the founder of the company, has been in the natural supplement industry for over 35 years and has launched some of the most well-known products in Europe with his vast retail network relationships. T-Cell Protect is rolling out the Tollovid family of Products under the T-Cell brand throughout Europe.

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 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 and Investor Contact:

Richard Galterio

Todos Medical

732-642-7770

rich.g@todosmedical.com