Todos Medical Announces Positive Biomarker Data from Phase 2 Trial of Tollovir in Hospitalized COVID-19 Patients
- Biomarker data correlates with clinical data announced in January 2022
- 46 patient open label extension being opened to support US FDA EUA application
New York, NY, and Tel Aviv, ISRAEL, June 30, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced biomarker data from its majority-owned joint venture 3CL Pharma Ltd.’s Phase 2 clinical trial of Tollovir™ in hospitalized COVID-19 patients. The data showed a positive correlation between the clinical data announced for Tollovir on January 27, 2022 and biomarkers associated with acute phase immune response (IL-6), inflammation (C reactive protein), blood clotting (D-dimer) and immune response to COVID-19 (cPass neutralizing antibodies). Additionally, renal and hepatic biomarker data showed no signals of treatment-associated risk with Tollovir therapy.
“We are very pleased to have confirmed that all the key biomarker endpoints IL-6, CRP, D-Dimer and cPass neutralizing antibodies correlate with the improved clinical outcomes associated with Tollovir treatment,” said Dr. Dorit Arad, co-founder of 3CL Pharma. “With these data in hand, we plan to reproduce the findings in a slightly larger patient population as part of the open label extension. Once we complete our recruitment of a handful more patients, we will be able to present our data package to regulatory authorities worldwide regarding the benefit of Tollovid therapy in addition to standard of care versus standard of care alone.”
Recent peer reviewed literature shows the predictability of key biomarker data such as IL-6, CRP, and D-Dimer in the hospitalized setting. The existence of these studies allows us to focus resources on recruiting just active patients.
“We believe the correlative biomarker data, in addition to the positive clinical results previously reported in hospitalized patients primarily from the Delta variant wave, should elevate Tollovir’s profile in the eyes of regulators,” said Gerald Commissiong, President & CEO of Todos Medical and Interim-CEO of 3CL Pharma. “After review with our regulatory attorneys, we believe that if additional data from our planned open label extension of the study (N up to 46, all to receive Tollovir) are consistent with the data from the blinded, placebo-controlled trial segment (N = 20 in Part 2), we will apply for an Emergency Use Authorization (EUA) in the United States and Europe. Given that the extension is open label, we will be able to look at the data on an ongoing basis as we interact with regulators and submit data as they become available. Initiating the extension study in the very near future is our priority, as BA.5-related hospitalizations at our primary clinical trial site at Shaare Zedek Medical Center in Jerusalem, Israel have increased over 1400% in the last 3 weeks. The data gathered from this BA.5 wave will be a compelling part of the EUA submission to the US Food & Drug Administration and European Medicines Agency.”
To purchase Tollovid please visit Amazon or www.MyTollovid.com.
https://www.globenewswire.com/news-release/20...ients.html
- Biomarker data correlates with clinical data announced in January 2022
- 46 patient open label extension being opened to support US FDA EUA application
New York, NY, and Tel Aviv, ISRAEL, June 30, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced biomarker data from its majority-owned joint venture 3CL Pharma Ltd.’s Phase 2 clinical trial of Tollovir™ in hospitalized COVID-19 patients. The data showed a positive correlation between the clinical data announced for Tollovir on January 27, 2022 and biomarkers associated with acute phase immune response (IL-6), inflammation (C reactive protein), blood clotting (D-dimer) and immune response to COVID-19 (cPass neutralizing antibodies). Additionally, renal and hepatic biomarker data showed no signals of treatment-associated risk with Tollovir therapy.
“We are very pleased to have confirmed that all the key biomarker endpoints IL-6, CRP, D-Dimer and cPass neutralizing antibodies correlate with the improved clinical outcomes associated with Tollovir treatment,” said Dr. Dorit Arad, co-founder of 3CL Pharma. “With these data in hand, we plan to reproduce the findings in a slightly larger patient population as part of the open label extension. Once we complete our recruitment of a handful more patients, we will be able to present our data package to regulatory authorities worldwide regarding the benefit of Tollovid therapy in addition to standard of care versus standard of care alone.”
Recent peer reviewed literature shows the predictability of key biomarker data such as IL-6, CRP, and D-Dimer in the hospitalized setting. The existence of these studies allows us to focus resources on recruiting just active patients.
“We believe the correlative biomarker data, in addition to the positive clinical results previously reported in hospitalized patients primarily from the Delta variant wave, should elevate Tollovir’s profile in the eyes of regulators,” said Gerald Commissiong, President & CEO of Todos Medical and Interim-CEO of 3CL Pharma. “After review with our regulatory attorneys, we believe that if additional data from our planned open label extension of the study (N up to 46, all to receive Tollovir) are consistent with the data from the blinded, placebo-controlled trial segment (N = 20 in Part 2), we will apply for an Emergency Use Authorization (EUA) in the United States and Europe. Given that the extension is open label, we will be able to look at the data on an ongoing basis as we interact with regulators and submit data as they become available. Initiating the extension study in the very near future is our priority, as BA.5-related hospitalizations at our primary clinical trial site at Shaare Zedek Medical Center in Jerusalem, Israel have increased over 1400% in the last 3 weeks. The data gathered from this BA.5 wave will be a compelling part of the EUA submission to the US Food & Drug Administration and European Medicines Agency.”
To purchase Tollovid please visit Amazon or www.MyTollovid.com.
https://www.globenewswire.com/news-release/20...ients.html
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