Todos Medical Announces Positive Observational Trial Results for Oral Antiviral 3CL Protease (MPro) Inhibitor Tollovir®
- Treatment group participants experienced a reduction in key inflammatory biomarker
- Observed a reduction in time of hospitalization and death rate with no deaths recorded in treatment group
New York, NY, and Tel Aviv, ISRAEL, Sept. 30, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced results from an observational study of 32 hospitalized COVID-19 patients treated with Tollovir®, the Company’s proprietary oral antiviral 3CL protease inhibitor treatment. This exploratory study of 11 treated patients was compared with 21 randomly selected untreated patients in the hospitalized setting who had similar baseline characteristics during the time the 11 patients were voluntarily recruited into the study. Additionally, the Company released two key case studies of interest that demonstrated the potential clinical utility of Tollovir. All clinical results were collected by the Company’s joint venture partner NLC Pharma in Israel. Dr. Ilan G. Ron, Clinical Professor of Oncology and Radiotherapy at Tel Aviv Medical Center Faculty & Medicine served as the Principal Investigator for the observational study.
“After decades of working to bring 3CL protease science to the forefront, we are disclosing the first initial clinical evidence of real-world benefit of our 3CL protease inhibitor drug candidate Tollovir® in a hospitalized patient setting,” said Dr. Dorit Arad, Founder & Chief Scientific Officer of NLC Pharma. “We are extremely encouraged by these results, and this is really what pushed us to collaborate with Todos on bringing this potentially game-changing treatment forward in double-blind controlled clinical studies, which are currently in progress.”
Results showed zero deaths in the Tollovir-treated group versus 5 deaths in the observed group. The mean age was slightly higher in the Tollovir group. The biomarker C-Reactive Protein (CRP) was measured upon hospitalization and tallied the number of patients that were able to experience a 50% reduction in this inflammatory biomarker within 48 – 72 hours. In the Tollovir group, 50% of the patients experienced a reduction of 50% of more in CRP versus only 10% in the observed group. Tollovir appeared to be well tolerated and showed only minor incidences of diarrhea which is consistent with the disease.
Tollovir® groupObserved groupAge (range)45-8760-90Age (Mean)7573Hospitalization Days (range)6-194-41Hospitalization Days (mean)13.317.4Died in hospital05Deteriorated to respirator and recovered03High CRP serum levels at hospitalization1020CRP reduction of 50% and more within 48-72 hours5 (50%)2 (10%)
Two case studies being released today which represent real-world use of the ingredients comprising Tollovir also showed successful outcomes after repeated failure from the Standard of Care treatment, including the EUA approved oral antiviral, Remdesivir.
Case Study #1
The patient was so severe that they were considering ECMO because her CRP was at 120 and her oxygen saturation was at 85%. This patient was given Tollovir, and stabilization in oxygen saturation at 98% was observed just 12 hours after treatment. The next day the CRP levels fell to 65, four days later her levels measured at 15, and eventually returned to normal shortly thereafter. She left the hospital 8-9 days after receiving Tollovir. This highlights the potential immunomodulatory properties of Tollovir that warrant further investigation.
Case Study #2
The patient had 3 comorbidities: ischemic heart disease, hypertension, and obesity. Despite treatment with antibiotics and steroids, his condition continued to deteriorate to the point of requiring hospitalization. He refused hospitalization and was offered the ingredients comprising Tollovir along with vitamins. Within 48 – 72 hours he reported improvement. Within 4 days the shortness of breath and cough almost completely disappeared.
“Based on these trial results, there appear to be very strong efficacy signals for Tollovir in treating hospitalized COVID-19 patients,” said Gerald Commissiong President & CEO of Todos Medical. “As we move forward in our clinical development program we expect Tollovir to do well in the upcoming rigorous placebo-controlled studies that are starting very soon at Shaare Zedek in Jerusalem. We are aggressively planning our expansion into new sites in Israel in order to accelerate enrollment because we believe that both the data generated in hospitalized patients and the observational study will support Emergency Use Authorization (EUA) applications in various jurisdictions. The reduction in mean hospitalization in our trial also shows that our planned next generation formula of Tollovir could have a significant impact on flattening the curve. These groundbreaking results are hypothesis generating and lend credence to our thesis about the Mechanism of Action (MOA) of Tollovir and its ability to treat a wide range of patients during the entire pathogenesis of COVID-19.”
https://investor.todosmedical.com/news-events...onal-trial
- Treatment group participants experienced a reduction in key inflammatory biomarker
- Observed a reduction in time of hospitalization and death rate with no deaths recorded in treatment group
New York, NY, and Tel Aviv, ISRAEL, Sept. 30, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (“Todos Medical”) (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced results from an observational study of 32 hospitalized COVID-19 patients treated with Tollovir®, the Company’s proprietary oral antiviral 3CL protease inhibitor treatment. This exploratory study of 11 treated patients was compared with 21 randomly selected untreated patients in the hospitalized setting who had similar baseline characteristics during the time the 11 patients were voluntarily recruited into the study. Additionally, the Company released two key case studies of interest that demonstrated the potential clinical utility of Tollovir. All clinical results were collected by the Company’s joint venture partner NLC Pharma in Israel. Dr. Ilan G. Ron, Clinical Professor of Oncology and Radiotherapy at Tel Aviv Medical Center Faculty & Medicine served as the Principal Investigator for the observational study.
“After decades of working to bring 3CL protease science to the forefront, we are disclosing the first initial clinical evidence of real-world benefit of our 3CL protease inhibitor drug candidate Tollovir® in a hospitalized patient setting,” said Dr. Dorit Arad, Founder & Chief Scientific Officer of NLC Pharma. “We are extremely encouraged by these results, and this is really what pushed us to collaborate with Todos on bringing this potentially game-changing treatment forward in double-blind controlled clinical studies, which are currently in progress.”
Results showed zero deaths in the Tollovir-treated group versus 5 deaths in the observed group. The mean age was slightly higher in the Tollovir group. The biomarker C-Reactive Protein (CRP) was measured upon hospitalization and tallied the number of patients that were able to experience a 50% reduction in this inflammatory biomarker within 48 – 72 hours. In the Tollovir group, 50% of the patients experienced a reduction of 50% of more in CRP versus only 10% in the observed group. Tollovir appeared to be well tolerated and showed only minor incidences of diarrhea which is consistent with the disease.
Tollovir® groupObserved groupAge (range)45-8760-90Age (Mean)7573Hospitalization Days (range)6-194-41Hospitalization Days (mean)13.317.4Died in hospital05Deteriorated to respirator and recovered03High CRP serum levels at hospitalization1020CRP reduction of 50% and more within 48-72 hours5 (50%)2 (10%)
Two case studies being released today which represent real-world use of the ingredients comprising Tollovir also showed successful outcomes after repeated failure from the Standard of Care treatment, including the EUA approved oral antiviral, Remdesivir.
Case Study #1
The patient was so severe that they were considering ECMO because her CRP was at 120 and her oxygen saturation was at 85%. This patient was given Tollovir, and stabilization in oxygen saturation at 98% was observed just 12 hours after treatment. The next day the CRP levels fell to 65, four days later her levels measured at 15, and eventually returned to normal shortly thereafter. She left the hospital 8-9 days after receiving Tollovir. This highlights the potential immunomodulatory properties of Tollovir that warrant further investigation.
Case Study #2
The patient had 3 comorbidities: ischemic heart disease, hypertension, and obesity. Despite treatment with antibiotics and steroids, his condition continued to deteriorate to the point of requiring hospitalization. He refused hospitalization and was offered the ingredients comprising Tollovir along with vitamins. Within 48 – 72 hours he reported improvement. Within 4 days the shortness of breath and cough almost completely disappeared.
“Based on these trial results, there appear to be very strong efficacy signals for Tollovir in treating hospitalized COVID-19 patients,” said Gerald Commissiong President & CEO of Todos Medical. “As we move forward in our clinical development program we expect Tollovir to do well in the upcoming rigorous placebo-controlled studies that are starting very soon at Shaare Zedek in Jerusalem. We are aggressively planning our expansion into new sites in Israel in order to accelerate enrollment because we believe that both the data generated in hospitalized patients and the observational study will support Emergency Use Authorization (EUA) applications in various jurisdictions. The reduction in mean hospitalization in our trial also shows that our planned next generation formula of Tollovir could have a significant impact on flattening the curve. These groundbreaking results are hypothesis generating and lend credence to our thesis about the Mechanism of Action (MOA) of Tollovir and its ability to treat a wide range of patients during the entire pathogenesis of COVID-19.”
https://investor.todosmedical.com/news-events...onal-trial
