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Todos Medical Announces Data Lock in Tollovir Phase 2 Clinical Trial for the Treatment of Hospitalized COVID-19 Patients

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Todos Medical, Ltd. (OTCQB: TOMDF) announced a data lock for the interim analysis of its Tollovir™ Phase 2 Clinical Trial, targeting severe/critical COVID-19 patients. Results are set to be disclosed on January 27, 2022. Dr. Dorit Arad, Chief Scientific Officer at NLC Pharma, expressed enthusiasm for the upcoming clinical trial data. Tollovir, a 3CL protease inhibitor, is designed to treat COVID-19 and has shown promise in in vitro studies. Todos aims to advance this therapeutic in critical medical use, alongside partnerships targeting expanded applications.

Positive
  • Data lock for Tollovir™ Phase 2 Clinical Trial indicates progress.
  • Anticipated results could attract investor interest and validate the therapeutic approach.
Negative
  • Results of the interim analysis may not meet market expectations.
  • Potential delays in regulatory approval are a risk for future trials.

New York, NY, and Tel Aviv, ISRAEL, Jan. 24, 2022 (GLOBE NEWSWIRE) -- §  Clinical Data Will be Released Thursday, January 27th, 2022

via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, together with its 3CL protease theragnostic joint venture partner NLC Pharma Ltd., today announced a data lock for the interim data analysis for the Company’s Tollovir™ Phase 2 Clinical Trial for the treatment of hospitalized (severe/critical) COVID-19 patients. The Company will release the results on Thursday, January 27th, 2022.

“We are very excited to see the first controlled clinical trial data for Tollovir,” said Dr. Dorit Arad, Founder & Chief Scientific Officer of NLC Pharma, Todos Medical’s 3CL protease biology theragnostics joint venture partner. “We are also looking forward to completing the formation of 3CL Sciences to advance this critically important science into medical use.”

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 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. In 2021, Todos completed the acquisition of 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. 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 is focused on the commercialization of Videssa and will bring the TBIA tests to market thereafter.

Todos has entered into a joint venture with NLC Pharma targeting diagnostic and testing solutions to address the COVID-19 pandemic. The Joint Venture is pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses. The Company’s proprietary therapeutic candidate Tollovir™ is currently in a Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, and is preparing to initiate Phase 2/3 clinical trials for both hospitalized and non-hospitalized patients in Israel.

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 is also distributing certain (COVID-19) testing materials and supplies to CLIA-certified labs in the United States. The products cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.

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 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 is the purpose of the Tollovir™ Phase 2 Clinical Trial?

The trial aims to assess the safety and efficacy of Tollovir™ in treating hospitalized patients with severe/critical COVID-19.

When will the results of the Tollovir™ clinical trial be released?

The interim data analysis results are scheduled to be released on January 27, 2022.

What does Tollovir™ target in COVID-19 patients?

Tollovir™ is a 3CL protease inhibitor designed to disrupt a fundamental reproductive mechanism of coronaviruses.

How does the clinical trial impact Todos Medical (TOMDF)?

Positive results could enhance Todos Medical's market value and investor confidence, while negative results may lead to stock price decline.

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