New York, NY, and Tel Aviv, ISRAEL - (NewMediaWire) - May 06, 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 14 update. The update is from an ongoing 30-day case study by Dr. Lee Morgentaler of a 3CL protease cleanse with Tollovid, a 3CL protease inhibitor dietary supplement, in a patient who experienced COVID Rebound following intervention with Pfizer’s Paxlovid.

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 history of multiple SARS-CoV-2 infections and persistent PASC, who received the therapeutic intervention Paxlovid following a positive PCR test and experienced severe rebound of symptoms starting on Day 5, the final day of Paxlovid treatment. The patient’s symptoms were resolved following an initial 14-day cleanse with 3CL protease inhibitor immune support dietary supplement Tollovid®.

SUMMARIZED CASE REPORT

A 53-year-old female in excellent physical condition experienced four COVID-19 infections over the course of two years between March 13, 2020 through April 20, 2022.  The patient is a single mother with a son in college and lived a very reclusive lifestyle.  Her current blood panels suggest that she is now immunocompromised.  Before the first COVID-19 infection on March 13, 2020 the patient did 3 to 6 miles of daily trail running four times per week.  She also taught school three times per week and cycled the 8-mile distance to work each time.  She was 5 ft 6 in, 160 lb, had a resting pulse rate of 60, and had all blood work within normal limits.  At the time immediately prior to beginning intervention with Tollovid in this case study she weighed 185 lb, her blood work was abnormal, and she was experiencing vision problems and gastrointestinal issues that resulted in the removal of her gall bladder.  From March 13, 2020 to April 20, 2022 she experienced 13 trips to the Emergency Room.

In March 2020, after isolation for a week the patient presented COVID-19 symptoms of elevated heart rate, shortness of breath, GI tract issues, difficulty breathing, and what the patient describes as debilitating body spasms.  These symptoms were so severe that the patient had to be transported to the hospital by ambulance. 

In May 2020, after experiencing worsening symptoms the patient checked into Rust Medical Center in Rio Rancho with excruciating abdominal pain.  A cholecystectomy was performed on an emergency basis.  The GI symptoms subsided after surgery.  During that hospital stay she tested negative on a nasal PCR test. 

A fecal COVID test was done in July 2020.  The first fecal test was negative for COVID but the patient was not having any symptomatic issues related to the GI tract. The patient remained in complete isolation for the next couple of weeks and then had a GI flare up when the second test was completed.  This fecal COVID test was COVID-19 positive.  The patient eventually recovered and returned baseline and was able to run up to six miles again.  

In February 2021, the patient received the first in a series of two Pfizer vaccination shots.  The patient tolerated the vaccinations without any side effects.

The next infection occurred in June 2021 shortly after the patient broke a 4-month long isolation.  The patient broke isolation to meet travelers who were only wearing cloth masks for protection while driving an hour in the car.  The patient started showing symptoms within 2 days after potential exposure.  These symptoms included elevated heart rate, fever up to 101, pain in the chest, insomnia, swollen veins, loss of appetite, red eyes, trembling, pulse oximeter reading of 93% to 94%, and diarrhea.  She took over-the-counter electrolytes, vitamin C&D, iron supplements, and resveratrol.  Recovery took 3 weeks and the patient was able to resume long walks and her temperature normalized. 

Despite the patient’s diligence in practicing self-isolation, thereafter she was exposed to a person who took off their mask.  At the time the patient was wearing a cloth mask.  Within two days of the exposure the patient was infected for the 3rd time and remained sick for at least a month.  The patient tested COVID-19 positive on August 24, 2021 by a lateral flow antigen test.  The symptoms manifested more in her eyes, nasal passage, and auditory system.  Symptoms included ringing in the ears and double vision.

On December 15, 2021, the patient removed her P100 mask and airtight goggles during a medical exam and then presented symptoms of COVID-19 within 3 days.  The patient tested COVID-19 positive via rapid antigen test on December 18, 2021.  The patient exhibited signs of Long COVID which include fever, tremors, headaches, diarrhea, and shortness of breath. These symptoms continued to persist until April 8, 2022.

On April 1, 2022, the patient started taking prednisone to treat her red swollen hands, vasculitis, and easy bruising.  On April 8, 2022, the patient started showing signs of COVID and took a PCR rapid test which showed a faint positive reading.  On April 14th, her doctor prescribed a 5-day course of Paxlovid.  Within hours the patient was symptom free.  She was able to clean the house and felt so well she went on a four-mile hike. She also noticed that this was the first time she was able to sleep through the night in two years.  The patient also did voiceovers, and her voice came back briefly during this period.  On the 5th day of Paxlovid treatment she saw a return of her symptoms.  She became bedridden on day 5 with shaking, tremors, 101 fever, and claylike feces.  On April 19th the patient still tested COVID-19 positive. 

On April 21, 2022, the patient started a regimen of Tollovid.  She took three capsules four times a day for 14 days. Her symptoms began to resolve within 24 hours and continued to improve for ten days.  The patient is awaiting results of a complete blood panel.  However, on May 4, 2022, she tested COVID-19 negative via NP/OP swab resulted on rtPCR.  Additionally, a C-Pass neutralizing antibody test was performed indicating 94.731% inhibition with titers greater than 6000 u/ml.  The patient reported that as of three days ago all her symptoms were resolved.  She attributes this recovery to the treatment with Tollovid. The patient plans on continuing to take two capsules of Tollovid twice a day for the next 14 days. 

DISCUSSION:

This case study reveals that the patient responded to 3CL protease inhibitors Paxlovid and Tollovid.  Tollovid acted as an excellent rescue agent for Paxlovid failure in Long COVID or COVID-19.  The patient observed relief in hours using both treatments.  The patient was fully vaccinated and it didn’t prevent infection. 

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 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 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