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 (OTCQB: TOMDF) has paused enrollment in its Phase 2 clinical trial of Tollovir®, an antiviral candidate for COVID-19, to conduct an interim analysis. The analysis will now involve 31 patients instead of the planned 33, as recommended by the statistician due to indications of futility. Results are expected by the end of Q4 2021. The trial aims to assess hospitalization duration and clinical improvement metrics. Jules Mitchel, PhD, has been appointed as a strategic advisor for the interim analysis, leveraging his extensive clinical research experience.
- Retention of Jules Mitchel, PhD, as a strategic advisor for interim analysis.
- Interim analysis will provide controlled clinical data, potentially validating antiviral efficacy.
- Enrollment paused due to indications of futility in the trial.
- Reduced patient count for interim analysis from 33 to 31 may raise concerns.
- Enrollment now paused in the randomized, double blind, placebo controlled clinical trial in severe and critical hospitalized COVID-19 patients to complete interim analysis
- Data from the interim analysis expected in the end of 4th Quarter of 2021
- Jules Mitchel, PhD, appointed as strategic advisor to assist with the interim analysis
New York, NY, and Tel Aviv, ISRAEL, Nov. 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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:
- Reduction in the duration of hospitalization
- Time to clinical improvement as defined by the National Early Warning System 2 (NEWS2)
Secondary endpoints will include:
- Death
- Incidence and duration of time on supplemental oxygen
- 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 | 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.
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 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 and Investor Contact:
Richard Galterio
Todos Medical
732-642-7770
rich.g@todosmedical.com
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