Breaking News: Todos Medical Announces Completion of Enrollment for COVID-19 Oral Antiviral 3CLPro (Mpro) Inhibitor Tollovir Phase 2 Clinical Trial Interim Analysis in Severe and Critical Hospitalized Patients | Financial Buzz

Breaking News: Todos Medical Announces Completion of Enrollment for COVID-19 Oral Antiviral 3CLPro (Mpro) Inhibitor Tollovir Phase 2 Clinical Trial Interim Analysis in Severe and Critical Hospitalized Patients

Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, together with its 3CL protease biology-focused joint venture partner NLC Pharma, Ltd., today is very pleased announce an update regarding the ongoing clinical development of Tollovir®, a oral antiviral 3CL protease (3CLpro, Main protease, Mpro, Nsp5) inhibitor & anti-cytokine therapeutic candidate for the treatment of COVID-19. The enrollment of the 77-patient, Phase 2, randomized, double-blind, placebo controlled clinical trial in hospitalized COVID-19 patients has been paused at the two open clinical sites in Israel, Shaare Zedek Medical Center in Jerusalem and Hillel Yaffe Medical Center in Hadera, to allow for an interim analysis of the data. The Company expects data from the interim analysis to be reviewed by the trial Data Safety and Monitoring Board (DSMB) in the fourth quarter of 2021.

Concurrent with this announcement, the Company announced that it has retained the services of Jules Mitchel, PhD, to assist the Company with the interim analysis. Dr. Mitchel has an extensive background in the clinical trial and regulatory affairs space, previously serving as Founder & CEO of global clinical research organization (CRO) Target Health from its founding in 1993 until it was sold to dMed Biopharmaceuticals in 2019.

The interim analysis, previously scheduled to occur at 33 patients, will now be conducted on the 31 patients enrolled in the trial as of November 10, 2021 based on the recommendation from the statistician using blinded data that indicated the clinical trial has likely met the threshold required to evaluate futility.

The primary endpoints for the trial are:

  1. Reduction in the duration of hospitalization
  2. Time to clinical improvement as defined by the National Early Warning System 2 (NEWS2)

Secondary endpoints will include:

  1. Death
  2. Incidence and duration of time on supplemental oxygen
  3. Incidence of deterioration and need for mechanical ventilation

In the event that a patient is intubated at the time of or after enrollment into the trial, Tollovir is able to be administered via feeding tube to continue therapy. Following the interim analysis, the Company will make decisions on the next steps in the clinical development program for Tollovir in COVID-19 for patients who are (1) hospitalized, (2) present with moderate disease, (3) have Long Haulers (Post –Acute Sequelae of SARS CoV-2) and (4) are less than 18 years of age.

“We are very happy with the acceleration of the clinical trial to the point that we will get our first controlled clinical data,” said Dr. Dorit Arad, Founder and Chief Scientific Officer of NLC Pharma. “We will now obtain the first placebo-controlled clinical trial data for Tollovir as an adjunct to the standard of care for the treatment of hospitalized COVID-19 patients, after promising data from our observational study conducted in 2020. We are very excited for this moment that could become a pivotal turning point for physicians who treat hospitalized COVID-19 patients.”

“Once Pfizer released its Phase 2/3 data on their drug candidate PAXLOVID™ in the outpatient setting, it clinically validated the 3CL protease as a stellar antiviral target that appears to be unaffected by variants,” said Gerald E Commissiong, President & CEO of Todos Medical. “The 3CL protease is a target capable of producing robust clinical outcomes. This gives us tremendous confidence going into this interim analysis that we should be able to confirm the strong efficacy signals seen in last year’s Tollovir observational study. We are confident that our naturally derived antiviral will have an enviable safety profile. If the interim results resemble the observational study, demonstrating a significant reduction of time in the hospital and death, it will cement the direction of our clinical trial pathway. We believe Tollovir could become a highly sought-after therapeutic candidate in the hospitalized setting which represents patients at the highest risk of death and the highest cost of care. The benefit of reducing time in the hospital would be quite significant, as it is expected to open up hospital capacity for non-COVID related ailments, which represents a significant benefit for patients and healthcare systems during COVID surges.”

DATA FROM 32 PATIENT OBSERVATIONAL STUDY CONDUCTED IN 2020

Tollovir®  Control 
Number of patients treated 11 21
Age (mean; range) 75 (45-87) 73 (60-90)
Hospitalization Days (mean; range) 13.3 (6-19) 17.4 (4-41)
Died in hospital  0 5
Deteriorated to respirator and recovered 0 3
CRP reduction of 50% and more within 48-72 hours 5 2

For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.

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.

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.

Sponsored Content Release. Click for Full Disclosure

Opt-into our eNewsletter NOW! For the Latest Trending Financial News Topics in Cannabis, Tech, Biotechs, Precious Metals, Energy, Renewable Energy and much more!

  • Sponsored Content Release

    FinancialBuzz.com, a leading financial news informational web portal designed to provide the latest trends in Market News, Investing News, Personal Finance, Politics, Entertainment, in-depth broadcasts on Stock News, Market Analysis and Company Interviews. A pioneer in the financially driven digital space, video production and integration of social media, FinancialBuzz.com creates 100% unique original content. FinancialBuzz.com also provides financial news PR dissemination, branding, marketing and advertising for third parties for corporate news and original content through our unique media platform that includes Newswire Delivery, Digital Advertising, Social Media Relations, Video Production, Broadcasting, and Financial Publications.

    Please Note: FinancialBuzz.com is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on http://www.FinancialBuzz.com (the ‘Site’) is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content), FinancialBuzz.com, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. FinancialBuzz.com has not been compensated directly by any of the companies mentioned here in this editorial unless mentioned otherwise. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. FinancialBuzz.com receives fees for producing and presenting high quality and sophisticated content on FinancialBuzz.com along with other financial news PR media services. FinancialBuzz.com does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. FinancialBuzz.com only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. For todos medical ltd. video production, filming editing, news reporting, financial and corporate news dissemination, FinancialBuzz.com has been compensated five thousand dollars by the company. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. FinancialBuzz.com will always disclose any compensation in securities or cash payments for financial news PR advertising. FinancialBuzz.com does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security. FinancialBuzz.com, members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. FinancialBuzz.com. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by FinancialBuzz.com constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by FinancialBuzz.com. Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use, please visit: http://www.financialbuzz.com.