New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - September 27, 2022 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned joint venture 3CL Pharma Ltd. received a Notice of Allowance issued by the USPTO for the Company’s proprietary SARS-CoV-2 3CL protease (Main protease, Mpro, Nsp5) diagnostic TolloTest™ that was developed to detect and quantify the presence of 3CL protease in human tissue samples. TolloTest has been initially validated in upper respiratory tract (swab) samples and can provide PCR-like accuracy with convenience similar to that of a rapid antigen test. The Company previously announced positive data on TolloTest in hospitalized and outpatient settings such as skilled nursing facilities and schools.
The test is designed to quantify 3CL protease, which is being measured for correlation with infectiousness and potentially a key feature of the SARS-CoV-2 viral persistence pathology in Long COVID. TolloTest is a potential companion biomarker test for the Company’s 3CL protease inhibitor dietary supplement Tollovid and a companion diagnostic for its Phase 2 asset Tollovir for hospitalized COVID. TolloTest can be commercialized as a rapid point-of-care test in single use and mass screening formats, as an at-home test for single use, and as a laboratory developed test (LDT) for use in high complexity CLIA labs and mobile labs for patient monitoring.
“The tremendous work we did in Israel in discovering and proving this 3CL protease disease mechanism will be crucial in the next steps of expanding the widespread adoption of supplements and drugs to reduce SARS-CoV-2 replication and immune system downregulation,” said Dr. Dorit Arad, Founder and Chief Technology Officer at 3CL Pharma.
“The US market is huge and is in desperate need for new types of diagnostics to measure different aspects of the SARS-CoV-2 virus, especially in hospitalized patients and Long COVID,” said Gerald Commissiong, CEO of 3CL Pharma. “Many of our existing testing customers in schools and nursing homes utilize our PCR testing to try to control community spread. The TolloTest has the potential to be a much better mousetrap in controlling community spread because it could detect people earlier in the disease pathogenesis. As such, we believe the 3CL protease is something that should be monitored closely, especially since there are products on the market in the US that address it, and it could result in a change in physician recommendations.”
The global COVID-19 diagnostics market size is expected to reach USD 50.1 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 7.7% from 2022 to 2030. The Company expects significant innovation will be required to improve the accuracy of point of care diagnostics and TolloTest could play a key role in area.
TolloTest is a diagnostic assay centered on identifyoing and quantifying the 3CL protease and its activity levels in order to be able to approximate active viral replication. The test is intend to be used to monitor patients in hospital settings, measure levels of infectiousness among individuals seeking release from quarantine, as well as potentially evaluating protease persistence in Long COVID patients.
About Tollovid™ and Tollovid Daily™
Tollovid and Tollovid Daily are oral dietary supplement products made from natural ingredients that help support and maintain healthy immune function and also have potent 3CL protease inhibition properties based upon in vitro functional assays that show strong inhibition of 3CL protease activity. Tollovid and Tollovid Daily bind to the active site of the 3CL protease. 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 daily immune support product with a dosing regimen of twice daily. Preliminary data from an ongoing IRB-waived study of customers who used the products to assist with their COVID and Long COVID were recently announced.
Tollovir is an oral 3CL protease inhibitor and anti-cytokine therapeutic candidate targeting the Nidovirus group of viruses that includes coronaviruses such as 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 has successfully completed 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 COVID and, potentially, pediatric 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 examines 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, Long COVID Panel analyses, and Provista's proprietary commercial-stage Videssa® breast cancer blood test. More information on Provista is available at www.provistadx.com.
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 formed the Israeli-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of the intellectual property surrounding 3CL protease–based diagnostic testing and development of 3CL protease botanical and pharmaceutical inhibitors that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid™ in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™.
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 the 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
917-983-4229 x 104
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