Todos Medical Launches Phase 2 Clinical Trial of I
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Posted On: 04/19/2021 11:25:08 AM
Todos Medical Launches Phase 2 Clinical Trial of Its Antiviral 3CL Protease Inhibitor NLC-V-01 (Tollovir) in Hospitalized COVID-19 Patients
First 10 patients dosed in 77 patient randomized, double blind, placebo controlled Phase 2 Clinical Trial at Shaare Zedek Medical Center in Jerusalem, Israel
Data from randomized, placebo controlled, open label Phase 1b trial in 27 hospitalized COVID-19 patients supports dose selection for the Phase 2 Clinical Trial
Company to include its proprietary 3CL protease enzymatic assay (“TolloTest™) as exploratory theranostic biomarker
NEW YORK, NY, and REHOVAT, ISRAEL, April 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced the initiation of a randomized, double blind, placebo-controlled Phase 2 clinical trial (the “Clinical Trial”) of its antiviral NLC-V-01 (“Tollovir™”), a potent 3CL protease inhibitor, for the treatment of hospitalized COVID-19 patients. The trial, being conducted at Shaare Zedek Medical Center in Jerusalem, Israel, will evaluate the safety and efficacy of Tollovir for the treatment of COVID-19 in hospitalized patients. Tollovir is a patent-pending therapeutic agent being developed through a joint venture between Todos Medical and NLC Pharma. 3CL protease inhibitors are targeted as desirable candidates for development of antiviral therapies against SARS-CoV-2 (the virus that causes COVID-19).
The primary endpoints of the Clinical Trial being examined are:
Time to discharge from the hospital
Time to clinical improvement based upon the National Early Warning Score 2 (NEWS2) in Israel
The secondary endpoints of Clinical 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
A synopsis of the Clinical Trial is available on the Israel Ministry of Health’s website at: https://my.health.gov.il/CliniTrials/Pages/MOH_2021-01-20_009687.aspx
Commenting on the Phase II trial, Dr. Dorit Arad, Co-Founder and Chief Scientific Officer of NLC Pharma, stated, “The launch of this Clinical Trial is a critical step towards the clinical validation of our proprietary scientific work that was recently further supported with data from the Dan Peer laboratory at Tel Aviv University in Israel concluding that our proprietary medical grade 3CL protease inhibitor, Tollovir, is an antiviral therapeutic candidate for SARS-CoV-2’s based on its 3CL protease reproduction mechanism. 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.”
Dr. Arad continued, “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.”
“The solid peer-reviewed scientific evidence regarding 3CL protease inhibitors as antiviral drugs against coronaviruses, together with recent in vitro data generated at Tel Aviv University that we reviewed in detail showing Tollovir’s activity of inhibiting SARS-CoV-2 replication, and quite importantly, a review of the empirical data from people using the dietary supplement in hospitalized settings all strongly encourage us to perform this Phase 2 study. The goal is to provide results that could have a significant impact on our ability to treat hospitalized patients diagnosed with COVID-19,” said Dr. Rokach, MD Lung Specialist and Principal Investigator of the Clinical Trial at Shaare Zedek Medical Center in Jerusalem.
“We are excited by the initiation of this clinical trial for Tollovir,” said Gerald E. Commissiong, President & CEO of Todos. “Dr. Arad’s history with this therapeutic target is well-known throughout the field of coronavirus research, and Todos is proud to support this very important clinical development program at a time when emerging variants are potentially threatening the progress that has been made in the last year as the field focused on COVID-19 vaccine development. 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.”
https://investor.todosmedical.com/news-events...ial-of-its
First 10 patients dosed in 77 patient randomized, double blind, placebo controlled Phase 2 Clinical Trial at Shaare Zedek Medical Center in Jerusalem, Israel
Data from randomized, placebo controlled, open label Phase 1b trial in 27 hospitalized COVID-19 patients supports dose selection for the Phase 2 Clinical Trial
Company to include its proprietary 3CL protease enzymatic assay (“TolloTest™) as exploratory theranostic biomarker
NEW YORK, NY, and REHOVAT, ISRAEL, April 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced the initiation of a randomized, double blind, placebo-controlled Phase 2 clinical trial (the “Clinical Trial”) of its antiviral NLC-V-01 (“Tollovir™”), a potent 3CL protease inhibitor, for the treatment of hospitalized COVID-19 patients. The trial, being conducted at Shaare Zedek Medical Center in Jerusalem, Israel, will evaluate the safety and efficacy of Tollovir for the treatment of COVID-19 in hospitalized patients. Tollovir is a patent-pending therapeutic agent being developed through a joint venture between Todos Medical and NLC Pharma. 3CL protease inhibitors are targeted as desirable candidates for development of antiviral therapies against SARS-CoV-2 (the virus that causes COVID-19).
The primary endpoints of the Clinical Trial being examined are:
Time to discharge from the hospital
Time to clinical improvement based upon the National Early Warning Score 2 (NEWS2) in Israel
The secondary endpoints of Clinical 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
A synopsis of the Clinical Trial is available on the Israel Ministry of Health’s website at: https://my.health.gov.il/CliniTrials/Pages/MOH_2021-01-20_009687.aspx
Commenting on the Phase II trial, Dr. Dorit Arad, Co-Founder and Chief Scientific Officer of NLC Pharma, stated, “The launch of this Clinical Trial is a critical step towards the clinical validation of our proprietary scientific work that was recently further supported with data from the Dan Peer laboratory at Tel Aviv University in Israel concluding that our proprietary medical grade 3CL protease inhibitor, Tollovir, is an antiviral therapeutic candidate for SARS-CoV-2’s based on its 3CL protease reproduction mechanism. 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.”
Dr. Arad continued, “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.”
“The solid peer-reviewed scientific evidence regarding 3CL protease inhibitors as antiviral drugs against coronaviruses, together with recent in vitro data generated at Tel Aviv University that we reviewed in detail showing Tollovir’s activity of inhibiting SARS-CoV-2 replication, and quite importantly, a review of the empirical data from people using the dietary supplement in hospitalized settings all strongly encourage us to perform this Phase 2 study. The goal is to provide results that could have a significant impact on our ability to treat hospitalized patients diagnosed with COVID-19,” said Dr. Rokach, MD Lung Specialist and Principal Investigator of the Clinical Trial at Shaare Zedek Medical Center in Jerusalem.
“We are excited by the initiation of this clinical trial for Tollovir,” said Gerald E. Commissiong, President & CEO of Todos. “Dr. Arad’s history with this therapeutic target is well-known throughout the field of coronavirus research, and Todos is proud to support this very important clinical development program at a time when emerging variants are potentially threatening the progress that has been made in the last year as the field focused on COVID-19 vaccine development. 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.”
https://investor.todosmedical.com/news-events...ial-of-its
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