Todos Medical Applauds White House Initiative on Long COVID and Announces New Tollovid® US FDA Certificate of Free Sale with Daily and Acute Dosing on the Label

Rhea-AI Summary

Todos Medical, Ltd. (OTCQB: TOMDF) announced that its subsidiary 3CL Pharma supports the Biden Administration's effort to combat Long COVID, affecting over 22 million Americans. The FDA granted a Certificate of Free Sale for its dietary supplement Tollovid®, effective for both acute and chronic dosing. A recent case study showed complete symptom resolution in a Long COVID patient following Tollovid treatment. Additionally, the development of Tollovir™, a therapeutic candidate for severe COVID-19, reported promising Phase 2a clinical trial results.

Positive

• FDA granted Certificate of Free Sale for Tollovid®, allowing for both acute and chronic dosing.
• Phase 2a study of Tollovir™ showed a 40% reduction in hospital stay and 100% reduction in death during therapy.
• Tollovid demonstrated complete resolution of Long COVID symptoms in a case study.

Negative

• None.

New York, NY, and Tel Aviv, ISRAEL, April 06, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire --Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned subsidiary 3CL Pharma, Ltd. applauds the Biden Administration’s Acceleration of Whole-of-Government Effort to Prevent, Detect, and Treat Long COVID announced on April 5th, 2022. The Company believes that the tremendous burden of Long COVID, recently estimated to affect over 22 million Americans and leading directly to over 7 million Americans with disabling Long COVID with a total personal financial burden of over $380 billion dollars, must be met with an overwhelming investment in new therapies for Long COVID with a government focus akin to Operation Warp Speed.

Concurrent with this announcement, the Company announced that the US FDA recently granted a new Certificate of Free Sale for its proprietary 3CL protease inhibitor, immune support dietary supplement Tollovid® that allows for both acute dosing for immune support (12 pills per day for 5 days) and chronic daily dosing for maintenance (2 pills per day) on the same label. A recent case study was reported by Dr. John Mabayoje outlining the potential benefit of Tollovid in the treatment of debilitating Long COVID in which a 49-year old female Long COVID sufferer who was chronically testing COVID positive by PCR for over 3 months from initial COVID diagnosis and experienced Long COVID symptoms including low energy, excessive somnolence, easy fatigability, myalgia, and headaches. This patient saw complete resolution of all Long COVID symptoms following the initial 5-day dosing regimen of Tollovid, immediately afterwards tested negative by COVID PCR, and was able to return to her job as a flight attendant immediately afterwards while staying healthy for four months to date following Tollovid intervention. The Company intends to conduct further research in this area with Tollovid, and is currently working to turn Tollovid into an OTC drug. Tollovid is currently not approved to diagnose, treat, prevent or cure any disease, including COVID or Long COVID. 

Additionally the Company is developing the separate, but related, therapeutic drug candidate Tollovir™ for the treatment of hospitalized COVID-19 (severe/critical) that recently completed a Phase 2a clinical study at Shaare Zedek Medical Center in Jerusalem, Israel in which Tollovir + standard of care (SOC) showed superiority vs. SOC alone. In the Phase 2a study the Tollovir treatment arm showed 40% reduction in time in the hospital (10.6 days vs. 17.8 days), 100% reduction in death while on therapy (0% vs. 22%) and 50% benefit in patients achieving clinical improvement a measured by the National Emergency Warning System 2 rating scale, also known as NEWS2, (100% vs. 67%). Tollovir is currently available by compassionate use at Shaare Zedek Medical Center for patients, and the Company is preparing regulatory submissions in certain jurisdictions for Emergency Use Authorization (EUA) outside the United States and preparing for a Phase 2b/3 trial to support US FDA and other regulatory government submissions.

“It is clear that the scale of the COVID pandemic has dramatically raised the stakes for chronic disease in the United States,” said Gerald E. Commissiong, President & CEO of Todos Medical, the parent company of 3CL Pharma. “At its peak, it was estimated that during the Omicron wave over 3 million cases were recorded per day in the United States. Recent estimates suggest that roughly 10% of those who recover from COVID will suffer from Long COVID, and furthermore that the risk factor for diabetes in those who were diagnosed with COVID within the last 12 months were at a 2% higher likelihood of developing diabetes. This is a national and international emergency at an unprecedented scale that could have reverberating impacts for decades to come for societies that allow COVID to spread widely. We must immediately marshal the resources necessary to bring to market all the different effective therapies that could have a benefit in the treatment of Long COVID and initiate studies to address this major public health issue. Chronic disease pre-COVID represented an almost $1.2 trillion market, and Long COVID is likely to dramatically exacerbate this problem. As such, we stand with the Biden Administration to underscore the urgent need for new therapies to treat Long COVID.”

About Tollovid® 

Tollovid is a dietary supplement product made from natural ingredients that help support and maintain healthy immune function and also has 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 as strong as Ivermectin’s published 3CL protease IC50 binding affinity. Tollovid binds 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. 

About Tollovir®

Tollovir® is a 3CL protease inhibitor and anti-cytokine therapeutic candidate for the treatment of the nidovirus subcategory of coronaviruses that includes 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 is currently in 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 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 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

Todos Medical

917-983-4229 x 104

Dan.h@todosmedical.com

Todos Investor Relations Contact:

Eric Ribner

LifeSci Advisors

Email: eric@lifesciadvisors.com

FAQ

What recent announcement did Todos Medical make regarding Long COVID?

Todos Medical supports the Biden Administration's efforts to address Long COVID, which affects over 22 million Americans.

What is Tollovid and how is it approved?

Tollovid is a dietary supplement for immune support; it received a Certificate of Free Sale from the FDA for acute and chronic dosing.

What were the results of the Phase 2a clinical study for Tollovir?

The study showed a 40% reduction in hospital stay and a 100% reduction in death rates compared to standard treatment.

How effective was Tollovid in treating a Long COVID patient?

A case study reported complete symptom resolution in a Long COVID patient after a 5-day regimen of Tollovid.

What is the ticker symbol for Todos Medical?

The company's ticker symbol is TOMDF, traded on the OTCQB.