Todos Medical provides update on COVID-19 oral antiviral 3CL protease inhibitor (main protease) clinical development program Tollovir in light of Merck’s molnupiravir clinical trial data

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Todos Medical provides update on COVID-19 oral antiviral 3CL protease inhibitor (main protease) clinical development program Tollovir in light of Merck’s molnupiravir clinical trial data


New York, NY, and Tel Aviv, ISRAELL, October 04, 2021 (GLOBE NEWSWIRE) – via NewMediaWire — All Medical, Ltd. (“All Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today provided an update on its Tollovir® Clinical Development Program, COVID-19 Oral Antiviral 3CL Protease Inhibitor (“Master Protease” or “Mpro”) , which is currently in a Phase 2 clinical trial in hospital patients at Shaare Zedek Medical Center in Jerusalem, Israel. In light of the Data Safety Monitoring Board (DSMB) overseeing the Merck trial in consultation with the US Food & Drug Administration (FDA), the halt in recruitment after an interim analysis of 775 patients revealed a 50% reduction in the risk of hospitalization and death in unvaccinated outpatients. COVID-19 patients enrolled in Merck’s Phase 3 clinical trial within 5 days of symptom onset, Todos has now begun an in-depth reassessment of outpatient trial designs to provide the fastest path to put Tollovir on. the outpatient market as it is now significantly below the expected patient recruitment threshold required to demonstrate efficacy.
There are currently 27 patients enrolled in the 77 inpatient Tollovir clinical trial in Israel. A predefined interim analysis of the safety and efficacy data for Tollovir is planned in 33 patients, which the Company expects to recruit in the coming weeks. Upon completion of the course of treatment enrollment for the 33rd patient, the Tollovir DSMB will meet to review the data and decide whether further enrollment in the clinical study is warranted. Additional clinical trial sites that currently have higher volumes of COVID patients in Israel are expected to be added to the study in order to speed up recruitment.

Tollovir is a proprietary formulation of key plant extracts that contain potent, highly selective activities of natural 3CL protease inhibitor (Mpro) and anti-cytokines that make Tollovir a potent therapeutic candidate for the treatment of COVID-19 . The ingredients in Tollovir have been found to be safe for widespread use by several regulatory agencies around the world, including the US FDA, and have been used in more than 5,000 human subjects since the start of the COVID pandemic. -19, with some case studies previously shared publicly. Other oral antiviral drug candidates for COVID-19, such as Molnupiravir from Merck and PF-07321332, from Pfizer are chemical compounds that have not yet been deemed safe for widespread human use by a regulatory body. Given Tollovir’s strong safety profile, the Company believes it offers a compelling alternative to newly created or reused failed chemical drug candidates that have yet to rigorously demonstrate long-term safety.

“Together with NLC Pharma, our joint venture and co-development partner of Tollovir, we were pleasantly surprised by the decision of Molnupiravir DSMB to stop recruiting into the Merck clinical study at the pre-defined interim point of analysis after showed a 50% reduction in hospitalizations and deaths based on 775 patients enrolled, ”said Gerald Commissiong, President and CEO of Todos Medical. “While it is a tremendous outcome for patients with COVID-19 and the global community at large to have an oral antiviral that demonstrates a statistically significant reduction in the most severe outcomes of this devastating disease, it is clear to us based on the data we saw this decision was likely driven more by the huge need in the market for oral antiviral therapy than by the data itself for this mutagenesis-based drug candidate given the scarcity the safety data available for Molnupiravir in COVID-19, and the entry criteria required for its phase 3 clinical trial.

On September 30, 2021, Todos announced the results of an observational clinical study conducted in Israel by NLC Pharma. The results of this observational study are presented below:

Groupe Tollovir® Observed group
Age range) 45-87 60-90
Middle age) 75 73
Hospitalization days (range) 6-19 4-41
Hospital days (mean) 13.3 17.4
Died in hospital 0 5
Deteriorated on respirator and recovered 0 3
Elevated serum CRP levels on hospitalization dix 20
Reduction of CRP by 50% and more in 48-72 hours 5 (50%) 2 (10 %)

Dr Dorit Arad, Scientific Director of NLC Pharma, said: “Our biggest obstacle to finalizing a full development program for outpatient Tollovir has been trying to decipher what regulators are likely to accept as safety and efficacy endpoint. Given the actions of the DSMB in stopping the trials, coupled with the positive comments heard by Dr Fauci and Dr Scott Gottlieb regarding the efficacy demonstrated by Molnupiravir, we are now very comfortable having a comparator product. against which to build our endpoints for Tollovir. We now intend to engage with regulators in India as well as Israel, where we are currently recruiting a double-blind, placebo-controlled phase 2 clinical study in hospitalized patients with pending interim data reading, to discuss how we can now finalize a pivotal ambulatory design trial (s) and start moving quickly with recruitment as we also prepare for a pre-IND meeting with the US FDA which will be followed by a development program well-defined American clinic.

For more information, please visit www.todosmedical.com. For more information about Provista Diagnostics, Inc.’s CLIA / CAP Certified Lab, please visit www.provistadx.com.

About Todos Medical Ltd.

Founded in Rehovot, Israel, with offices in New York, Todos Medical Ltd. (OTCQB: TOMDF) designs vital diagnostic solutions for the early detection of a variety of cancers. In 20201, Todos completed the acquisition of U.S. medical diagnostics company Provista Diagnostics, Inc. to secure the rights to its CLIA / CAP certified lab based in Alpharetta, Georgia, which currently performs COVID PCR testing and blood testing. Provista Videssa® Breast Cancer Commercial Stage. test. The company’s state-of-the-art, patented Todos Biochemical Infrared Analyzes (TBIA) is a proprietary cancer screening technology using peripheral blood analysis that deploys a comprehensive examination of the influence of cancer on the immune system, researching biochemical changes in mononuclear cells in blood and plasma. The two cancer screening tests developed in-house by Todos, TMB-1 and TMB-2, have received CE marking in Europe. Todos is focused on commercializing Videssa and will subsequently commercialize the TBIA tests.

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

Todos is also developing blood tests for the early detection of neurodegenerative diseases, 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 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 reentry of the cell cycle 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 also distributes certain (COVID-19) testing materials and supplies to CLIA certified laboratories in the United States. The products cover multiple suppliers of PCR test kits, extraction kits, automation equipment and supplies, as well as COVID-19 antibody and antigen test 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 clinical development programs and expected clinical trials. These forward-looking statements are based only on management’s current expectations and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in forward-looking statements, including risks and uncertainties associated with 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 secure the 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 forward-looking statements: changes in technology and market requirements; delays or obstacles in starting our clinical trials; changes in legislation; the inability to develop and introduce new technologies, products and applications in a timely manner; the lack of validation of our technology as we progress and the lack of acceptance of our methods by the scientific community; failure 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; a higher cost of the final product than expected; loss of market share and price pressure resulting from competition; and laboratory results which do not translate into equally good results under actual conditions, which could cause actual results or performance to differ materially from those contemplated in such forward-looking statements. Unless otherwise provided by law, Todos Medical does not undertake to publish revisions of 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 refer to its reports filed from time to time with the United States Securities and Exchange Commission.

Contact Companies and Investors:

Richard Galterio

All Medical

732-642-7770

[email protected]

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