- Trials will separately enroll non-hospitalized and hospitalized patients
- Clinical trials in India targeted to be adaptive design to enable expansion into pivotal development upon achieving data milestone
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.
“We are pleased to have completed this critical step of retaining a CRO for Tollovir’s clinical development in India and are very impressed with Innvocept’s deep experience in executing rapidly enrolling FDA quality COVID-19 clinical trials with over 10 completed to date, and successfully working with US-based pharmaceutical companies to execute successful clinical trials in India,” said Gerald E. Commissiong, President & CEO of Todos Medical. “Enrollment is also starting to accelerate in our ongoing 77 patient Phase 2 randomized placebo-controlled trial of Tollovir™ at Shaare Zedek Medical Center in Jerusalem, Israel for the treatment of hospitalized COVID-19 patients. 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 Company’s proprietary 3CL protease biomarker assay that is being developed as a more accurate measure of viral infection, load and infectiousness in COVID-19 patients.”
Mr. Commissiong continued, “As we move forward with the clinical development of Tollovir in Israel, we felt it was critical to have a second program recruiting in a larger, less vaccinated jurisdiction that has the potential for faster recruitment. We believe this dual-track clinical development program in Israel and India will have the benefit of showing Tollovir’s clinical efficacy in hospitalized patients when compared to, or in combination with, different standards of care that are emerging internationally. We are also now heavily engaged in planning Tollovir’s US regulatory strategy and planning for a pre-IND meeting with the US Food & Drug Administration ahead of an IND submission we are hopeful to file in the third quarter of 2021. This submission will set the stage for the opening of a US IND and clinical studies intended to ultimately dovetail our global pivotal clinical development program for Tollovir. The expansion of Tollovir’s clinical development into non-hospitalized patients dramatically opens the potential market opportunity for Tollovir, as it is becoming increasingly clear that vaccinated individuals will become infected with COVID-19 in addition to the unvaccinated and those with waning immunity.”
“We continue to compile non-clinical data that includes the Delta variant and is supportive of a regulatory filing for Tollovir. The initial clinical data gathered during a 32 patient Phase 2 open-label, controlled study conducted in Israel in 2020 at the height of the pandemic showed that Tollovir had statistically significantly improved results on key clinical endpoints including death rate, intubation, and mean time to patient discharge,” said Dr. Dorit Arad, PhD, Chief Scientific Officer of NLC Pharma. “Our internal mechanism of action data indicates that Tollovir possesses both exquisitely strong 3CL protease inhibition activity and anti-cytokine activity, based on distinct molecular mechanisms present in its formulation,” Dr. Arad continued. “This dual mechanism makes Tollovir unique among the emerging class of 3CL protease inhibitors currently in development. Researchers are quickly discovering that the fast-replicating Delta variant has shown an improved ability to out-compete neutralizing antibodies for the ACE2 receptors vs. earlier versions of SARS-CoV-2. The Delta variant heightens the call for a safe and effective oral antiviral therapy that can stop an infected person’s viral load from becoming so significant that it triggers cytokine release syndrome, which can lead to hospitalization, death or Long COVID. We believe Tollovir has addressed both viral replication and cytokine storm activity.”
Todos and NLC are currently finalizing study designs for both of its planned Tollovir Phase 2/3 trials in hospitalized and non-hospitalized patients in India, and Innvocept has already identified the clinical trial sites for these important studies. The Company estimates the direct costs to reach interim data for both trials in India will be collectively be approximately $1 million.
About Todos Medical Ltd.
Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista’s proprietary commercial-stage Videssa® breast cancer blood test.
Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos has entered into distribution agreements with companies to distribute certain (COVID-19) testing materials and supplies. The agreements cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits.
Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses.