New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - June 1, 2022 - Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned subsidiary 3CL Pharma, Ltd. reported a Day 26 update from an ongoing 60-day case study by Dr. Lee Morgentaler of a 3CL protease cleanse with Tollovid, a 3CL protease inhibitor dietary supplement, in a patient who originally contracted COVID in March 2021 and experienced symptoms of Long COVID.

ABSTRACT:

COVID-19 and Acute Sequelae of SARS-CoV-2 (PASC), or Long COVID, are major public health problems. Emerging evidence suggests the PASC, for many, may in fact be due to persistent SARS-CoV-2 infection that is able to evade vaccine or infection-induced immunity and cause recurring and persistent symptoms. PASC does not appear to protect against new acute SARS-CoV-2 infection, and PASC may in fact contribute to poor outcomes in new acute infections and/or recurrent symptoms from prior infection. We report a case of a patient with a single SARS-CoV-2 infection and thereafter persistent PASC, who received the pravastatin (10mg daily), low dose aspirin daily, and fluvoxamine (25mg daily) treatment regimen. Throughout the initial Tollovid® 5-day support dosing cycle, the patient discontinued all other therapies, including pravastatin, aspirin and fluvoxamine. While on Tollovid, the patient documented significant improvements in energy, brain fog, heart health and sleep. During the three weeks since the patient last took Tollovid, the patient reports maintenance of most of the gains after restarting treatment with pravastatin (10mg daily), low dose aspirin daily, and fluvoxamine (25mg daily) treatment regimen. The patient intends to restart use of Tollovid over a 10-day period in the near future to determine whether Tollovid can further improve his symptoms and whether those gains are subsequently maintained.

SUMMARIZED CASE REPORT

The subject is a 33-year-old male, 6’1” and weighed 195 lbs prior to onset of symptoms.  The subject considered himself to be in excellent physical condition.  He states prior to his bout with PASC, he played team sports such as hockey and soccer at least twice a week. By report, subject tested COVID-19 positive on March 29, 2021 via nasal pharyngeal PCR test.  The subject denies underlying medical conditions or any concerning family history of disease prior to testing COVID-19 positive. Within 3 days of known exposure to COVID-19 the subject began to exhibit symptoms, including loss of taste and sense of smell, extreme fatigue, profuse sweating, chills, and nausea.  The subject states the majority of symptoms subsided within 17 days of onset and was followed by a subsequent regression including shortness of breath, heart palpitations, insomnia, blurred vision, and light sensitivity.  The subject sought treatment at an urgent care facility. A chest x-ray ruled out pneumonia. He was housebound for 2 months during which time his weight decreased by 25 lbs, had a resting heart rate above 90 BPM which increased to 120 BPM with minimal exertion. By report, pre-COVID resting heart rate was 75 BPM.  His poor condition necessitated a move back into his parent’s house where his mother provided assistance with activities of daily living. 

In mid-June 2021 his level of fatigue significantly decreased and again worsened. This was followed by a series of improvements and regressions which cycled numerous times over the next 3 months.  Although his fatigue eventually resolved, he continued to note a heart rate which was above what was noted in the pre-COVID baseline, blurred vision, nausea, and his head felt concussed.  He described feeling like he had “brain inflammation.”  The subject was COVID-19 vaccinated on August 24, 2021 with the Pfizer vaccine and received the second of a series of 2 vaccinations on September 22, 2021.  There were no adverse side effects reported at the time of vaccination.

The subject states he was prepared to live with these symptoms for 7-8 months, but then sought out the assistance of a Long COVID clinic in February 2022.   By report, the clinic performed a complete cytokine panel which revealed elevated SCD40L which may be indicative of trauma-induced endothelial damage and coagulopathy.

The treating physician prescribed pravastatin (10mg daily), LD aspirin daily, and fluvoxamine (25mg daily).  The regimen brought relief to the subject in the form of significantly reducing the head concussed feeling in 2 weeks. At the completion date of the medication regimen, the balance of symptoms subsided. Following the discontinuation of the medications, symptoms returned within 24 – 48 hours. Subject restarted medications and once again achieved symptom relief within 72 hours.   After 2-3 months, the subject considered himself as back to a point where he could somewhat perform his usual routine despite continuing to experience symptoms including elevated heart rate, fatigue, nausea, and insomnia.  

On May 5, 2022 the subject started a regimen of Tollovid Maximum Strength.  He took 12 Tollovid capsules daily for 5 days. Symptoms significantly improved in 3 – 4 days and the patient discontinued use of Tollovid. After the 5 days of Tollovid use, the biggest improvement for the patient was digestion, which returned to his pre-COVID baseline.  He reported sleeping better and longer, however, his Garmin monitor showed that he was getting less deep sleep.  The head concussed feeling was minimal and his resting heart rate returned to pre-COVID values.  The subject noted a blood pressure of 110/65 which was better than his pre-COVID baseline of 120/80.  Weight was 200 lbs.  The subject noted he had always experienced heat intolerance which was no longer manifested after taking Tollovid. The subject states, overall, he feels physically better and now has excess energy.  The subject decided to stop Tollovid use to see if the gains would hold with additional Tollovid use.

On May 31st, 2022 follow-up, subject states subsequent to an interruption in continuing with Tollovid, and in an effort to stave off symptoms, he has started another round of treatment with Prevastatin 10 mg per day, Fluvoxamine 25 mg per day and daily low dose aspirin. In describing his ongoing symptoms, subject states he experiences “flare-ups” from time to time. “Prior to taking Tollovid, my flare-ups were an 8 out of 10” on the severity of symptoms scale, with 0 being no symptoms at all and 10 being the worst possible symptoms. “After taking Tollovid, [3 capsules, 4 times per day for 5 days,] my flare-ups are less intense with a rating of only 3 out of 10. Because of Tollovid, I am suffering less now.” The subject intends to restart the use of Tollovid for a 10-day period in the near future and to re-evaluate the patient’s Tollovid experience thereafter.

Discussion:

This case study shows Tollovid had a beneficial effect. The subject’s symptoms resolved with return to better than the pre-COVID baseline. This indicates the possibility there is an additional mechanism at work that may have been undiagnosed before the subject contracted Long COVID. The subject was diligent in eliminating any medicines before taking the Tollovid regimen. This strengthens the efficacy evaluation of the case study as it eliminates a number of potential variables.  Although the subject was not naïve to treatment, he states he was not taking any medications or other supplements that could explain the sudden change in health. The other significant observation was the normalization of resting heart rate.  Treatments, prior to Tollovid, alleviated some symptoms and provided relief, but didn’t address the elevated heart rate which underpins other symptoms such as the head concussed feeling.  Whatever mechanism was addressed by inhibiting 3CL protease was likely responsible for the reduction in heart rate to baseline levels.  The elimination of digestion issues further enhances the theory of viral persistence in reservoirs located in the gastrointestinal tract.  The lack of deep sleep measured by the Garmin sleep monitor should be noted.

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 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 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 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