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Todos Medical Retains CRO for COVID-19 Outpatient and Inpatient Phase 2/3 Clinical Trials for Oral Antiviral 3CL Protease Inhibitor Tollovir
Todos Medical Retains CRO for COVID-19 Outpatient and Inpatient Phase 2/3 Clinical Trials for Oral Antiviral 3CL Protease Inhibitor Tollovir.
About this update from Todos Medical Ltd.
[{"type":"text","content":"\n  Trials will separately enroll non-hospitalized and hospitalized patientsClinical trials in India targeted to be adaptive design to enable expansion into pivotal development upon achieving data milestone New York, NY, and Tel Aviv, ISRAEL, July 28, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire-- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced it has retained the services of Innvocept Global Solutions, an Indian clinical research organization (CRO), to manage 2 adaptive design Phase 2/3 clinical trials the Company is preparing to initiate with its joint venture partner NLC Pharma of its proprietary oral antiviral 3CL protease inhibitor drug candidate Tollovir™ for the treatment of non-hospitalized and hospitalized COVID-19 patients in India. Engaging a CRO is the first step of the regulatory process in India.  The Company expects enrollment for both trials to begin in the third quarter of 2021 with initial, trial expansion-enabling data expected in the fourth quarter of 2021 that could make each trial become part of the Company’s global pivotal clinical development program for Tollovir that would begin in the fourth quarter of 2021. “We are pleased to have completed this critical step of retaining a CRO for Tollovir’s clinical development in India and are very impressed with Innvocept’s deep experience in executing rapidly enrolling FDA quality COVID-19 clinical trials with over 10 completed to date, and successfully working with US-based pharmaceutical companies to execute successful clinical trials in India,” said Gerald E. Commissiong, President & CEO of Todos Medical.  “Enrollment is also starting to accelerate in our ongoing 77 patient Phase 2 randomized placebo-controlled trial of Tollovir™ at Shaare Zedek Medical Center in Jerusalem, Israel for the treatment of hospitalized COVID-19 patients. This trial opened enrollment in April 2021 and is also evaluating the use of TolloTest™ as a companion diagnostic for antiviral therapy.  TolloTest is the Company’s proprietary 3CL protease biomarker assay that is being developed as a more accurate measure of viral infection, load and infectiousness in COVID-19 patients.” Mr. Commissiong continued, “As we move f...