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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 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.
About this update from Todos Medical Ltd.
[{"type":"text","content":"\n  Enrollment now paused in the randomized, double blind, placebo controlled clinical trial in severe and critical hospitalized COVID-19 patients to complete interim analysisData from the interim analysis expected in the end of 4th Quarter of 2021Jules 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 hospitalizationTime to clinical improvement as defined by the National Early Warning System 2 (NEWS2) Secondary endpoints will include: DeathIncidence and duration of time on supplemental o...