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New York, NY, and Tel Aviv, ISRAEL, June 10, 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. reported a Day 45 update from an ongoing 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 February 2021 and experienced symptoms of Long COVID.
The subject is a 46-year-old, 6’0”, 210 pounds, unvaccinated male who describes his premorbid condition as healthy with 5 days per week of vigorous exercise and held a physically demanding job. By report, his blood pressure was 120/75 with a resting heart rate of 60 bpm. He tested positive for COVID-19 on 2 occasions, separated by 15 months. The subject reports exhibiting Long COVID symptoms because of his initial infection and failure of Paxlovid treatment due to adverse side effects with his second infection.
On February 14, 2021, the subject tested PCR positive with a nasal pharyngeal swab following exposure to a known COVID-19 positive person. His symptoms included fever peaking at 103 degrees Fahrenheit, runny nose, loss of taste and smell, cough, shortness of breath, fatigue, muscle pain, and severe headaches. He was experiencing shortness of breath noting a home use pulse oximeter reading of 94%. Five days later, the subject sought treatment in the local emergency department due to complaints of shortness of breath. Radiographic studies indicated the presence of pneumonia for which he was prescribed Azithromycin and home rest. Ten days after onset, the subject’s symptoms resolved with the notable exception of shortness of breath which he describes as being of such severity so as to significantly restrict his activities of daily living. The subject states, “I felt winded just walking to the mailbox. I couldn’t do my job or much of anything else.”
In April 2021, the subject consulted with a cardiologist and a pulmonologist. There were no significant findings reported. This prompted the subject to attempt returning to his exercise regimen. In June 2021, the shortness of breath persisted but the subject was determined to get back into his routine of working out. The subject continued to improve over the next 5 months noting he had returned to 80% of pre-COVID capacity.
In mid-September, the subject experienced a new onset of symptoms including feeling dizzy, pressure in his head, sleep disturbance, tachycardia, pain in his throat, and difficulty swallowing stating, “I felt as if my throat was closing.” He was able to tolerate only soft solid foods. There was a weight loss of 40 pounds over 8 weeks. An emergency department doctor diagnosed the tachycardia symptoms as a manifestation of anxiety. An ENT performed a nasopharyngoscopy and prescribed a proton pump inhibitor to treat GERD. The subject discontinued the medication after 2 weeks due to a lack of improvement in symptoms. The subject tested negative for COVID-19 with PCR.
During the next 4 months, the subject sought treatment and diagnostic testing from several medical specialists. A cardiologist diagnosed Post COVID POTS. The neurologist could find no evidence of POTS with autonomic testing. A tilt table test ruled out POTS. The subject was fitted with a cardiac halter monitor for 30 days. There were no significant findings. A rheumatologist ordered extensive serological testing which returned normal values with the notable exception of an elevated IL-10 biomarker. An anti-inflammatory cytokine, IL-10 can both impede pathogen clearance and ameliorate immunopathology. The rheumatologist made a diagnosis of Long COVID. The subject initiated treatment with a Long Hauler researcher who prescribed dexamethasone which was discontinued in 14 days due to the adverse side effect of crawling skin sensation. The subject stated, “This period of my life was a living hell.”
Between March and April 2022, the subject underwent 42 sessions in a hyperbaric oxygen chamber at 1.5 atmospheres which the subject found helpful in that he had more energy.
On April 28, 2022, the subject began supplementation with Tollovid. There were no concurrent therapeutic modalities. He took 3 capsules 4 times a day for 10 days. The subject states, “Within the first five days of taking Tollovid I felt 90 – 95 percent better.” Sleep improved from 4 to 7 hours per night. The sensation of head fullness resolved by the 3rd day. The feeling of dizziness when standing abated by the 8th day.
On day 11 (May 8th), the subject decreased the Tollovid dose to 6 capsules per day. The throat pain and flu-like symptoms returned. The subject tested PCR positive on May 20, 2022. He stopped Tollovid and began Paxlovid on May 23, 2022. The next morning, the subject felt everything was spinning and called the ambulance for transport to the hospital per the warning label on Paxlovid. A CT scan of the brain was unremarkable. On May 25th, the subject started Tollovid, 3 pills, 3 times per day for 5 days. All symptoms resolved. The subject states, “After five days of restarting Tollovid, I have recovered to 85 percent [of the premorbid condition]. I can run for 30 minutes, and my resting heart rate is back down to 60 [beats per minute].”
The subject was inoculated with a very large dose of COVID-19 from three children, and this was the key factor in a prolonged recovery. The lingering shortness of breath could have been a sign of viral persistence in the lungs that eventually overtook his immune system with a flare-up in his throat. The symptom of tachycardia seems to stem from viral persistence that was likely located in his lungs. He quickly resolved a number of his Long COVID symptoms after taking the 3CL protease inhibitor. The secondary COVID-19 infection allowed him to take Paxlovid but the side effects prevented any extended benefit. Tollovid immediately resolved the subject’s COVID-19 and Long COVID symptoms. Evidence of the heart rate returning to the pre-COVID baseline could lead to a complete resolution of the subject’s Long COVID symptoms and have him wean off the use of Tollovid.
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.
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/.
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.
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