New York, NY, and Tel Aviv, ISRAEL – April 20, 2022 - Todos Medical, Ltd. TOMDF, a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned subsidiary 3CL Pharma, Ltd. is reporting a case study from Dr. Lee Morgentaler of a patient who used Tollovid®, the Company’s 3CL protease inhibitor dietary supplement immune support product, after experiencing Long COVID symptoms. Concurrent with this report, the Company launched a website for physicians and pediatricians to indicate their interest in participating in a Long COVID clinical study of Tollovid for their patients. Provided here is a link to the website for physicians to indicate their interest in participating: https://todosmedical.com/long-covid-physicians-case-study
“Recent efforts designed to help Long COVID patients fall short in two critical areas,” said Gerald Commissiong, President & CEO of Todos Medical. “Drug developers need a validated test to diagnose Long COVID patients, and need approvable endpoint to run clinical trials. At this juncture, the medical community is only beginning to define Long COVID in patients, and validated clinical research tools needed to measure clinical benefit of interventions are lacking, although consensus is beginning to build in this area. We are seeing that case studies and anecdotal reports of benefit for patients with other approved 3CL protease inhibitors pave a way forward, however the inability to quickly change dosing and toxic side effects of those other products represent real barriers. We believe the societal impact we are seeing with Long COVID is just the tip of the iceberg, with direct impacts on GDP and workforce participation, which is why we cannot sit idly by and do nothing for this massive patient population when we believe clinical research into our 3CL protease inhibitor products is the right path forward. We hope the message being put forth by other clinical researchers that 3CL protease inhibition is a viable strategy resonates with physicians and patients alike, and that we galvanize can the Long COVID community into action to help us advance clinical research of our products for the potential benefit to patients.”
LONG COVID CASE STUDY
ABSTRACT:
Post-Acute Sequelae of SARS-CoV-2 (PASC), or Long COVID, is a major public health problem. We report a case of breakthrough PASC and its resolution following a course of the 3CL protease inhibitor dietary supplement Tollovid®.
SUMMARIZED CASE REPORT:
A 33-year-old male in top physical shape presented Covid-19 like symptoms of fatigue and loss of short term memory in mid-March 2020. The patient is a personal trainer and EMT that was 5’6” and weighed in at 135lbs. He was in top physical shape before Covid-19 and was able to run 3 miles in 20 minutes, bench press 225 lbs., dead lift 415 lbs., and squat 300 lbs. He worked out at least 5 days a week and went hiking. He and his family had no underlying medical conditions or allergies. The most likely source of infection was from the gym. The first symptom was the unexplained inability to run or lift weights and some occasional sneezing. The second symptom of short term memory loss coupled with dizziness appeared a couple of days after fatigue set in. The patient gained 25 lbs. in the next two weeks thinking that food would help him get better. The feasting didn’t work and then the patient resorted to intermittent fasting to get back down to his starting weight. Constant fatigue and memory loss and dizziness persisted for almost two years.
Despite the fatigue, dizziness, and loss of short term memory, the patient returned to work in June 2020. He was a private fitness trainer and could only do 2 sessions a week due to chest pains from exertion. There was no change in his condition until his second vaccination shot. He receive the first Pfizer shot on April 14, 2021 without any side effects beyond his base line status. On May 5, 2021 he received his 2nd Pfizer vaccination shot. Three weeks later he was hospitalized for chest pain and an inability to breath. The patient believed that this was post vaccine injury. Once in the hospital, tests were done on his EKG and blood and consistent with his baseline before contracting his first case of Covid-19. The hospital did not administer a Covid-19 test. His symptoms after the 3 day hospital stay were fatigue, dizziness, and memory loss.
In October 2022 the patient believes he contracted the Delta Variant. His wife tested Covid-19 positive and he had COVID-19 like symptoms of vomiting, diarrhea, coughing, worse fatigue, joint pain, and erectile dysfunction. One week after contracting Covid-19 he experienced left quadrant pain in his abdomen and successfully treated it with a colon rinse. His primary symptoms of fatigue, short term memory loss, joint pain, and erectile dysfunction persisted.
The patient started a regimen of Tollovid Daily on February 14, 2022. He took 2 Tollovid Daily capsules for 30 days, but his symptoms completely resolved in 3 days. His baseline on February 14, 2022 consisted of being able to work out 2 times per week, but continued to suffer from fatigue, memory loss, joint pain, and erectile dysfunction. He was unable to do simple things like walking his dog. After 3 days of treatment his fatigue subsided, his memory improved, the joint pain dissipated, and his erectile dysfunction was resolved. He returned to his baseline routine of working out 5 times a week and taking his 2 year old dog for walks. He no longer is treating himself for any Long Covid symptoms.
DISCUSSION
This case study reveals that even a small dosage of Tollovid Daily could be used to treat Long Covid. Given the quick and durable result more studies should be investigated in Long Covid. A major weakness of the study is the absence of a PCR positive Covid-19 test. The interesting part of this case study is related to the apparent vaccine injury that the patient suffered through. It has been documented in journal articles that a vaccine given during active COVID-19 infection could result in more severe disease. The presence of Long Covid followed by the second vaccination seems to support the theory that some cases of Long Covid are due to viral persistence. The delayed onset of the vaccine injury can be explained by low viral levels of viral persistence followed by a cytokine storm that led to hospitalization. The quick rebound to the pre-COVID baseline suggests that Tollovid was able to have a durable impact on the patient.
Disclaimer: Tollovid® and Tollovid Daily™ are 3CL protease inhibitor dietary supplement immune support products, and are not approved by the US FDA to diagnose, treat, prevent or cure any disease, including COVID-19 and/or Long COVID (Post-Acute Sequalae of COVID, or “PASC”).
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. 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
Todos Investor Relations Contact:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com
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