Todos Medical Releases Preliminary Data From IRB-Waived Tollovid® Market Research Study in Acute and Long COVID

Rhea-AI Summary

Todos Medical, Ltd. (OTCQB: TOMDF) released preliminary data from a market research study on its dietary supplement, Tollovid®, showing high satisfaction among respondents. Among 41 participants, 83% of those with acute COVID and 68% with long COVID reported satisfaction. Key findings include a 100% overall satisfaction for acute COVID users and up to 91.6% symptom improvement in short long COVID. Reported side effects were minimal, with dark stool in 17% of users. The company plans to utilize these findings to enhance product offerings and inform future clinical trials for its therapeutic candidate, Tollovir™.

Positive

• 83% satisfaction rate reported among acute COVID respondents.
• 68% satisfaction among long COVID participants.
• 100% of acute COVID users reported improvement in symptoms.
• 93.7% symptom improvement for short long COVID users.
• Company plans to leverage feedback for future product development and clinical trials.

Negative

• Non-approval status of Tollovid® for treating COVID or long COVID.
• Only 41.6% symptom improvement among chronic long COVID respondents.

83% of Respondents With Acute COVID Were Satisfied

68% of Respondents With Long COVID Were Satisfied

NEW YORK, NY, and TEL AVIV, ISRAEL, June 23, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced preliminary data from its majority-owned joint venture 3CL Pharma Ltd.’s ongoing IRB-waived sponsored market research study of the commercial use of Tollovid® as a dietary supplement. Among the first 41 respondents, of whom 78% were fully vaccinated against COVID-19, 13 reported that they began to use Tollovid when they were diagnosed with active COVID infection, whereas 28 respondents reported that they used Tollovid to address their Long COVID symptoms. 15 of the Long COVID respondents had experienced symptoms for up to 9 months (‘Short’ Long COVID), and 12 of the Long COVID respondents reported having symptoms for over 9 months (‘Chronic’ Long COVID). 18 of the 24 respondents who answered the question “Who diagnosed your Long COVID?” indicated that they were diagnosed by a medical professional. The preliminary results of the market research study are marked in the table below:

Overall Satisfaction	% w/Improved Symptoms	Happy with their results
Acute COVID	100.00%	83.00%
Short Long COVID	93.70%	87.50%
Chronic Long COVID	41.60%	41.60%
Key Symptoms Relieved	Symptom #1	Symptom #2
Acute COVID	Fatigue - 72.7%	Congestion - 63.6%
Short Long COVID	Fatigue - 91.6%	Headaches - 77.7%
Chronic Long COVID	Fatigue - 50%	Headaches - 40%
Reported Side Effects (≥5%)	Dark Stool	Muscle Twitching
	17%	5%

*  Tollovid® is not approved to diagnose, treat, prevent or cure any disease, including COVID and/or Long COVID

“We are pleased with the preliminary results from this sponsored market research study that show the majority of our customers are satisfied with Tollovid,” said Dr. Dorit Arad, Founder and Chief Scientific Officer at 3CL Pharma. “As we add to the growing body of information related to COVID, Long COVID and 3CL protease inhibitor products, we believe the knowledge gained from this market research study will allow us to tailor our offering to meet the needs of the immune competent (not immune compromised) and Long COVID communities, who currently have no 3CL protease inhibitor options on the market.”

“The learnings gathered from the use of our dietary supplement Tollovid will also allow us to design future Chronic Long COVID clinical trials for our therapeutic drug candidate Tollovir™, which is currently being prepared to enter a Phase 2/3 pivotal clinical study in hospitalized COVID patients,” said Gerald Commissiong, CEO at Todos Medical and Interim CEO at 3CL Pharma. “Because of Tollovid status as a dietary supplement on the market in the United States, we have a tremendous strategic advantage over competitors in Long COVID because we are in the position of being able to listen to the patients first hand describing how Tollovid supplementation, alone or sometimes in combination with other products, is helping them and apply this knowledge to our formal Tollovir Long COVID drug development plans.”

Respondents to the market research survey generally followed the directions on the Tollovid label, taking 12 capsules per day for 5 days among Acute COVID respondents, and taking at least 2 bottles of Tollovid according to the directions among Long COVID respondents. This market research study is not designed to assess optimal Tollovid dosing. No negative effects from interactions with other concomitant medications or supplements were reported by survey respondents.

To purchase Tollovid please visit Amazon or www.MyTollovid.com.

About Tollovid® and Tollovid Daily™

Tollovid and Tollovid Daily are 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.

About Tollovir®

Tollovir® is a 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/.

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

FAQ

What were the satisfaction rates for Tollovid among COVID patients?

83% of acute COVID patients and 68% of long COVID patients reported satisfaction with Tollovid.

How many respondents participated in the Tollovid market research study?

The study included 41 respondents.

What are the reported side effects of Tollovid?

The reported side effects include dark stool (17%) and muscle twitching (5%).

What future plans does Todos Medical have regarding Tollovid?

Todos Medical intends to use study feedback to enhance product offerings and inform clinical trials for Tollovir™.

What is Tollovir™?

Tollovir™ is a therapeutic candidate being developed for COVID-19 treatment.