Todos Medical initiates Phase 2 clinical trial in Israel of Tollovir to treat hospitalized coronavirus patients

Todos Medical Ltd (OTCQB:TOMDF) has announced the initiation of a randomized, double-blind, placebo-controlled Phase 2 clinical trial of antiviral Tollovir for the treatment of hospitalized coronavirus (COVID-19) patients.  The trial is being conducted at Shaare Zedek Medical Center in Jerusalem, Israel, and will evaluate the safety and efficacy of Tollovir, the company said. Tollovir is a patent-pending therapeutic agent being developed through a joint venture between Todos and NLC Pharma. It is among 3CL protease inhibitors that are targeted as desirable candidates for the development of antiviral therapies against SARS-CoV-2, the virus that causes the COVID-19 disease. READ: Todos wins Notice of Allowance from European Patent Office for patent covering cancer diagnosis using TBIA Immune Profiling Todos said the primary endpoints of the clinical trial being examined are the time to discharge from the hospital as well as the time to clinical improvement based upon the National Early Warning Score 2 (NEWS2) in Israel. In addition, the secondary endpoints of the trial being examined are: Rate of change of measured parameters Rate of change in vital signs (blood pressure, heart rate, respiratory rate, saturation, and body temperature) Time from the 1st day of receiving NLC-V treatment to negative RT-PCR test result COVID-19 related deaths Incidence of deterioration and need for mechanical ventilation Incidence and duration of time on supplemental oxygen “I am glad that my pioneering academic work over the last 30 years on 3CL mechanisms has made such a significant impact, and that it is finally being recognized by leading pharmaceutical companies as a key target in the war against COVID-19 that could yield an easy to administer oral antiviral therapeutic capable of stopping SARS-CoV-2 replication, independent of different mutations that are emerging at the site of spike protein,” said Dr Dorit Arad, co-founder and chief scientific officer of NLC Pharma in a statement. “In 2020, we enrolled 27 patients who participated in a Phase 1b open-label, placebo-controlled observational study in Israel of various formulations of this antiviral therapeutic candidate, and we also received feedback from patients all over the world who used certain dietary supplement formulations of our 3CL inhibitors to combat COVID-19 infection. Based on the data gathered from those two sources, we strongly believe that the further development of the selected formulation, Tollovir, is justified as a potential clinical therapeutic for significantly reducing the severity of a COVID-19 infection, and ultimately may be proven in further studies to be a prophylactic to reduce the risk of getting COVID-19 upon SARS-CoV-2 exposure.” Todos CEO Gerald Commissiong added: "By impacting SARS-CoV-2’s ability to reproduce in the body, we are hopeful to improve hospitalized patients’ clinical outcomes significantly, while also limiting the virus’ ability to mutate by reducing the number of times it is able to replicate in a host. Additionally, our TolloTest assay, currently optimized for inpatient settings, could be a valuable biomarker for measuring a person’s contagiousness by quantitatively measuring 3CL protease as a proxy for viral load, which could provide clearer objective data to make end of quarantine decisions when many PCR positive patients are likely inappropriately released from quarantine and able to infect others.” Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham