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Todos Medical Receives Trademark Notice of Allowance from USPTO for Its 3CL Protease Inhibitor Oral Antiviral Drug Candidate Tollovir™

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Todos Medical, Ltd. (OTCQB: TOMDF) announced a notice of allowance for a trademark for its oral antiviral drug candidate, Tollovir™, from the USPTO. This follows the completion of a Phase 1/2 clinical study and the enrollment of a Phase 2 trial in Israel. The company aims to engage the FDA for the Emergency Use Authorization pathway for Tollovir. Todos is also focused on advancing clinical studies and ensuring a distinct regulatory branding from its dietary supplement, Tollovid®. Ongoing research includes diagnostic solutions for COVID-19 and cancer detection.

Positive
  • Received USPTO trademark allowance for Tollovir™, enhancing product branding.
  • Ongoing Phase 2 clinical trial in Israel for Tollovir™ shows commitment to drug development.
  • Potential engagement with the FDA for Emergency Use Authorization pathway.
Negative
  • None.

New York, NY, and Tel Aviv, ISRAEL, Sept. 20, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a medical diagnostics and solutions company with comprehensive product offerings, today announced it has received a notice of allowance from the US Patent & Trademark Office (USPTO) for a trademark covering the Company’s proprietary 3CL protease inhibitor oral antiviral drug candidate NLC-V-01, also known as Tollovir™. In 2020, a Phase 1/2 clinical study evaluating the safety and efficacy of Tollovir in hospitalized patients was completed by the Company’s joint venture partner NLC Pharma Israel, and the Company and NLC are currently enrolling a Phase 2 clinical study in Israel in hospitalized patients. Pivotal Phase 2/3 clinical studies are currently being planned for both hospitalized and non-hospitalized patients.

“We are pleased with the speed with which the trademark for the brand name of our COVID-19 3CL protease inhibitor oral antiviral drug candidate Tollovir was issued,” said Gerald E. Commissiong, President & CEO of Todos Medical. “While we are pushing forward with our efforts to complete ongoing clinical studies in Israel and initiate pivotal studies in India, we are also very focused on engaging the US FDA to evaluate Tollovir potentially as part of the Emergency Use Authorization pathway in the United States. Results from the first clinical trial of Tollovir are being readied for release. We believe the USPTO moved quickly to authorize Tollovir’s trademark so that there would be a clear regulatory and marketing distinction with our dietary supplement product Tollovid®.”

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 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 20201, 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 and Investor Contact:

Richard Galterio

Todos Medical

732-642-7770

rich.g@todosmedical.com


FAQ

What is Tollovir™ and its significance for Todos Medical (TOMDF)?

Tollovir™ is a proprietary 3CL protease inhibitor oral antiviral drug candidate developed by Todos Medical, and its trademark allowance signifies progress in its branding and potential market entry.

What clinical trials is Todos Medical (TOMDF) currently conducting for Tollovir™?

Todos Medical is currently enrolling a Phase 2 clinical study for Tollovir™ in hospitalized patients in Israel, following a completed Phase 1/2 study.

How does Todos Medical (TOMDF) plan to engage with the FDA regarding Tollovir™?

Todos Medical intends to engage the FDA to explore the possibility of obtaining Emergency Use Authorization for Tollovir™ as part of its regulatory strategy.

What is the status of the clinical studies for Tollovir™?

Todos Medical is actively conducting a Phase 2 clinical trial for Tollovir™ and is planning pivotal Phase 2/3 studies for both hospitalized and non-hospitalized patients.

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