Todos Medical Partners with Amerimmune Diagnostics on Long COVID Biomarker Panel
NEW YORK, NY, AND TEL AVIV, ISRAEL, July 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP certified clinical laboratory Provista Diagnostics has entered into an agreement with Amerimmune Diagnostics, a CLIA/CAP certified laboratory with expertise in immune diagnostics and a leader in the field of clinical immunology and immune assessment of acute and long-COVID. Amerimmune will provide Provista clinically validated immune panels to assess patients with acute and long-COVID. Provista will complement the testing by measuring the immune system’s ability to produce neutralizing antibodies to the SARS-CoV-2 virus. All of the tests that are part of the Long COVID are currently covered by commercial insurance. The Long COVID Panel will provide key insights on inflammatory responses related to immune system cells, whether a patient is immune compromised, and whether a patient produces neutralizing antibodies. When a patient is deemed to be immune compromised, the patient becomes eligible for Evusheld® treatment. If there is evidence of inflammation, then the patients may benefit from various approaches, as deemed clinically appropriate by the treating physician. Amerimmune has an established nationwide blood sample collection agreement in place with Quest Diagnostics to facilitate access for Long COVID patients interested in getting tested.
“The COVID-19 pandemic has led to a massive population of survivors with immune abnormalities that are clinically presenting as Long COVID,” said Dr. Oral Alpan, Chief Medical Officer of Amerimmune Diagnostics. “Our new Long COVID Panel, which is comprised of our Standard Immunophenotyping Panel, our COVID Phenotyping Assay, and Provista’s total SARS-CoV-2 antibody panel and cPass surrogate viral neutralization test (sVNT or “cPass”), will allow us to provide valuable information for physicians who are looking to monitor the health of patients who have Long COVID and measure whether certain interventions are having an impact on objective biomarkers. Todos has brought to market the 3CL protease inhibitor immune support dietary supplement Tollovid that is beginning to gain traction in the Long COVID community. We believe that monitoring of the immune system’s core functions to the management of Long COVID is necessary in order to identify areas where intervention with therapeutics and/or dietary supplements may play a role in bringing biomarkers back into balance in a way that could result in symptomatic improvements.”
The Long COVID Panel consists of the following markers: lymphocyte subsets; T Cell panel - monitoring, activation markers, and memory (CD3, CD4, CD8, HLA-DR, CD25, CD57, TCR α/β TCR γ/δ; CD8, CD4 T cell memory); B cell panel (CD5, CD19, CD20, CD21, B cell surface antibodies, CD27, unswitched memory cells), LAG-3, Caspase-1, ICOS, HLA-DR, CD3, CD4, CD45RA, CD45RO, CD38, CD28, CD8, CD45, CXCR5, CD39, CD127, CCR7, CD25, CD317, CD27, CD19, CD20, CD59, CD97, CD14, CD55, cPass SARS-CoV-2 neutralizing antibody test and nucleocapsid (NP) SARS-CoV-2 IgG antibody test. A key feature of this panel is that it distinguishes between naïve and memory B and T cells. The companies expect to improve the Long COVID Panel over time by adding key new biomarkers that become validated in the literature, as well by removing biomarkers that prove inconsequential.
“Our early work with Tollovid in Long COVID seems to support the hypothesis that 3CL protease inhibition can have an impact on neutralizing antibody levels, however much more research is needed to understand and quantify this impact,” said Gerald Commissiong, President & CEO of Todos Medical. “We have seen a very high percentage of participants in our case study series discover upon initial screening that they are not producing neutralizing antibodies to SARS-CoV-2, even though they have been vaccinated and infected with the virus. We are also finding that some participants in our case study series produce neutralizing antibodies after extended time on Tollovid with those gains holding as the dose is reduced, whereas some participants do not produce neutralizing antibodies despite Tollovid having an impact on their symptoms while taking the supplement. This tells us that there is something more significant going on with the integrity of their immune system of those that do not produce neutralizing antibodies that requires further investigation. Amerimmune’s testing platform’s ability to measure the immune system’s integrity is profound and has already established itself as a reflex test for Evusheld eligibility; if the Amerimmune test shows a patient to be immune incompetent, then they become eligible for Evusheld prescription. We believe that 3CL protease inhibition and viral neutralization will be required to eliminate viral persistence in Long COVID, as viral persistence is emerging as a core feature of virus-induced Long COVID.”
For more information on the Amerimmune Long COVID Panel please visit:
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's 3CL protease IC50 binding affinity is at least ten times (10x) as strong as Ivermectin’s published 3CL protease IC50 binding affinity. Tollovid Daily’s 3CL protease IC50 binding affinity is at least two and a half times (2.5x) as Ivermectin. Tollovid and Tollovid Daily bind to the active site (receptor binding domain) 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-waiver study of customers who used the products to assist with their COVID and Long COVID was recently announced.
Tollovir® is an oral 3CL protease inhibitor and anti-cytokine therapeutic candidate for the intervention of 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-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. 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 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 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 pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitor botanical and pharmaceutical products 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 & anti-cytokine therapeutic drug candidate Tollovir®, while also developing the 3CL protease inhibitor diagnostic TolloTest™.
For more information, please visit https://www.todosmedical.com/.
About Amerimmune Diagnostics LLC
Founded in 2010, Amerimmune Diagnostics focuses on immunological testing as a solution to the unmet need and timely diagnosis of immune disorders. Amerimmune combines immunophenotyping flow cytometry testing, expert interpretation and recommendations. Amerimmune testing empowers the private practitioner to optimally manage their patient population.
For more information, please visit amerimmunediagnostics.com.
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:
917-983-4229 x 104
Released July 28, 2022