Todos Medical Retains CRO for COVID-19 Outpatient and Inpatient Phase 2/3 Clinical Trials for Oral Antiviral 3CL Protease Inhibitor Tollovir
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.
- 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 Companys proprietary 3CL protease biomarker assay that is being developed as a more accurate measure of viral infection, load and infectiousness in COVID-19 patients.
- This dual mechanism makes Tollovir unique among the emerging class of 3CL protease inhibitors currently in development.
- For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials.