Todos Medical Reports Day 28 Update for Case Study #5 with Erectile Dysfunction

New York, NY, and Tel Aviv, ISRAEL, June 07, 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 28 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 December 2021 and experienced symptoms of Long COVID, including erectile dysfunction.

ABSTRACT:

A 36-year-old, 5’ 8 ½” athletic male with a premorbid weight of 179 pounds, states he was able to overcome a case of Long COVID using an all-natural dietary supplement.  The subject is a Canadian government worker. He self describes as having led a very active life which included playing hockey at least 1 time a week, resistance training at least 2 times a week and jogging about 5 kilometers, 3 times a week. He could perform 20 pullups, 100 pushups, and 100 sit-ups during a workout session.  On May 24, 2021 he received his first vaccination shot from Pfizer.  On July 5, 2021 he received his second vaccination shot from Moderna.  There were no immediate side effects noted from either shot.

On December 17, 2021 he tested PCR positive via nasal pharyngeal swab.   The suspected source of infection was a co-worker who tested PCR positive on December 14, 2021.  Within 3 days of known exposure, the subject manifested symptoms including headache, runny nose, chills, sore throat, and cough.  He spent 10 days in isolation with many of the symptoms abating by the 5th day. Of note was a lingering cough which continued for an additional 12 days.

On January 2, 2022 the subject experienced what he perceived as significant personal stress, dealing with the death of his dog. Three days later the subject restarted his workout regimen.  After his first workout he experienced pain in his chest and felt uncoordinated.  He noticed that he was unable to grasp kitchen cabinets on the first try.  The following day it grew in severity, and he couldn’t lift his left arm due to a sensation of “pins and needles.”   Approximately 5 days later after he started exercising, he observed changes in his stool noting they appeared as “yellow mush.”  The subject described worsening symptoms including extreme fatigue, muscle twitches, frequent urination, loss of libido, sleep disturbance, and anxiety.

On January 26, 2022 the subject was administered a MRNA booster shot.  Almost immediately after the booster shot, he felt 90% relief from his extreme fatigue.  The pins and needles tingling, GI tract issues, muscle twitches, frequent urination, erectile dysfunction, insomnia, and anxiety were still prevalent.  The subject noted his scrotum was red and inflamed and sought treatment with a urologist. There was no significant finding.

Physical activity was very limited as the subject was unable to climb a run of stairs without feeling exhausted from the relatively minor physical exertion.  The frequent urination resolved by the end of February 2022.  An extensive 49 marker blood panel was drawn on March 9, 2022, that noted markers within normal ranges except for D-Dimer of 912ug/ml and mean cell Hemoglobin of 354g/L, which are both considered high.  In mid-April, the doctor prescribed 40mg of fluvoxamine daily for anxiety. The subject noted a reduction in symptoms within 2 weeks of treatment. The subject underwent 4 sessions of HBOT treatment at 2.0 atmospheres following which he experienced one night of solid sleep which he attributed to the HBOT treatments. 

On May 11, 2022, the subject started taking a regimen of Tollovid 3 pills 4 times daily for 10 days.  On May 13, 2022 the subject reported waking up with an erection.  The night of May 13th, 2022 the subject’s stools returned to normal and he was able to nap as desired without anxiety.  The visible redness of the scrotum also started to subside.  On May 16th, 2022 the subject reported less frequent pins and needles sensation in his left side.  The muscle twitching was more localized. 

On June 3rd, the subject reported less fatigue, significantly reduced inflammation in the scrotum, normalization of perspiration to pre-COVID state, and reduction in neurological symptoms (primarily pins & needles). The subject reported, “Tollovid has gotten me back to 85% of my pre-COVID state. No other intervention I’ve tried so far has been able to do that.” The subject has agreed to continue to participate in the Case Study series with Tollovid to advance the Company’s understanding of Long COVID. The subject is preparing to perform a follow-up blood panel test to evaluate any changes in previous results in addition to cPass neutralizing antibody testing.

Discussion:  This case study may demonstrate the viral persistence of SARS-CoV-2 in the subject’s scrotum was the proximal cause of the patient’s erectile dysfunction.  A major life stressor may have weakened the immune system allowing latent virus to manifest. By example, the hallmark of herpes is latent virus expressed with the introduction of stress upon the host.  The level of stress experienced by the subject in connection with the loss of his dog could have taxed the immune system allowing COVID-19 to persist in the active form long after the body should have cleared it.  There have been a number of reported cases of Long COVID where patients experienced relief after receiving the vaccine.  In this instance, it is possible stimulating the immune system with the vaccine helped to decrease symptoms of fatigue without ridding the body of the virus.  Post Exertion Malaise (PEM) is a key symptom of Long COVID and something the subject struggled with throughout the course of his disease.  The high D-Dimer indicates that the subject may have been suffering from a clotting effect localized to the scrotum as evidenced by the visible redness.  Such clotting would likely impede circulation to the penis resulting in erectile dysfunction. The subject’s use of Tollovid may have helped to reduce the inflammation of the scrotum and helped stop the replication of the virus in that area as evidenced by the reduction in redness and restoration of libido within 48 hours of administration.  The systemic reduction of symptoms throughout the body suggests that inhibiting 3CL protease limited the replication of the virus allowing the immune system additional time to build a more robust response better able to control and eradicate the virus.  Tollovid clearly had an effect on viral persistence in a Long COVID patient and further study is warranted in the treatment of erectile dysfunction caused by a COVID-19 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 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


Primary Logo

Source: Todos Medical Ltd.