Todos Medical Announces 2nd Clinical Trial Site for Tollovir Phase 2 Clinical Trial for the Treatment of Hospitalized COVID-19 Patients
Todos Medical, Ltd. (OTCQB: TOMDF) adds Hillel Yaffe Medical Center in Israel as the second site for its Phase 2 clinical trial of Tollovir, an antiviral candidate for hospitalized COVID-19 patients. The initial site, Shaare Zedek Medical Center, has enrolled 30 patients. An independent review of interim data is expected in Q4 2021 to inform further development. The recent publications in Nature Neuroscience and Cell Reports support the therapeutic's efficacy, prompting evaluations for use beyond hospitalized patients, potentially including moderate COVID cases and pediatric applications.
- Addition of a second clinical trial site is expected to accelerate patient enrollment.
- Interim analysis of safety and efficacy data anticipated in Q4 2021, guiding future development.
- Supportive publications in reputable journals bolster confidence in Tollovir's efficacy.
- Dependent on successful interim analysis for future trial phases and development direction.
- Risk of delays in obtaining regulatory approval could impact timelines.
§ Interim Clinical Trial Data from Phase 2 expected in Q4/21
§ Nature Neuroscience and Cell Reports publications highlight 3CLpro (Mpro)’s complementary mechanisms of virus replication and immune suppression
New York, NY, and Tel Aviv, ISRAEL, Nov. 01, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and theranostic solutions company, today announced it is now adding the Hillel Yaffe Medical Center as the 2nd clinical trial site in Hadera, Israel for its ongoing Tollovir® Phase 2 randomized, double blind, placebo controlled clinical trial for the treatment of hospitalized COVID-19 patients. Tollovir is an oral 3CL Protease (3CLpro, Main Protease, MPro, Nsp5) antiviral/anti-cytokine therapeutic candidate focused on blocking the 3CL Protease. The Shaare Zedek Medical Center in Jerusalem, Israel was the first site opened in April 2021 having enrolled 30 patients to date. An independent review of interim safety and efficacy data by the Data Safety Monitoring Board (DSMB) of the randomized trial data collected is expected in Q4/2021 that will guide the next steps in the program’s development path towards the therapeutic treatment of COVID-19.
“We believe the addition of a 2nd clinical trial site will accelerate enrollment in our ongoing Phase 2 randomized trial and also expand Tollovir’s clinical footprint,” said Gerald Commissiong, President & CEO of Todos Medical. “The upcoming data analysis is quite significant as it will guide the next steps in our clinical development pathway as we look at the potential use of Tollovir beyond hospitalized patients and potentially evaluating its efficacy in Moderate COVID (pre-hospital) and Long COVID in the future.”
“The recent functional validation of our 3CLpro long ongoing research by two independent groups with publications on 3CLpro in Nature Neuroscience and Cell Reports really provides strong support for the clinical outcomes we have seen in Israel since the pandemic began,” said Dr. Dorit Arad, Chief Scientific Officer of NLC Pharma, the Company’s 3CL protease therapeutic and diagnostics joint venture partner. “We are now evaluating the clinical development implications of these findings on our upcoming Tollovir Phase 2 interim analysis, as well as proposed programs in Moderate COVID and Long Haul trial, as well as looking at pediatric populations who have very few options at the moment. Given that Tollovir is well tolerated, we see the potential to help children suffering from COVID-19.”
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
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