The pandemic remains a major concern around the world. According to recent data published by Johns Hopkins University's Center for Systems Science and Engineering, more than 5.6 million people have died from the disease worldwide, including over 872,000 Americans. As for vaccination statistics, data from the CDC indicates that about 63.5% of the population in the United States is fully vaccinated against COVID-19. Nevertheless, since Thanksgiving, there have been nearly 84,000 confirmed deaths. The Omicron variant, while less lethal than the previous variants, is still highly contagious and is estimated to account for 99.9% of all new cases in the U.S. as of January. 22nd. Yesterday, over 21 million new weekly cases were reported across the globe, the most recorded since the beginning of the pandemic, according to the World Health Organization. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Novavax, Inc. (NASDAQ: NVAX), BioNTech SE (NASDAQ: BNTX), Sorrento Therapeutics, Inc. (NASDAQ: SRNE)
As a result of the high numbers of new cases, testing kits are in short supply. According to Anthony S. Fauci, Chief Medical Adviser to President Biden, it is going to be very important "that we get a greater capability of testing, particularly when the demand for testing is so high, with the combination of the Omicron variant itself, as well as the holiday season, where people want to get that extra level of assuredness that they're protected, even if you are vaccinated and boosted."
Todos Medical Ltd. (OTCQB: TOMDF) together with its 3CL protease theranostic joint venture partner NLC Pharma Ltd., announced yesterday breaking news regarding, "positive interim data for its Tollovir™ oral antiviral 3CL protease inhibitor Phase 2 clinical trial for the treatment of hospitalized (severe and critical) COVID-19 patients. Tollovir met its primary endpoint of reducing time to clinical improvement as measured by the National Emergency Warning System 2 (NEWS2) and met several key secondary clinical endpoints, including complete reduction in COVID-19 deaths. The Company has now formally closed the Phase 2 clinical trial due to positive interim efficacy data. Lead clinical site Shaare Zedek Medical Center now permits the use of Tollovir™ in hospitalized COVID-19 patients on a compassionate use basis.
The Company will host a conference call at 9:15am Eastern Time.
The Company will also be presenting at Emerging Growth Conference at 3:00pm Eastern Time.
'It is extremely exciting to see the validation of Tollovir in a placebo-controlled trial which now allows us to continue on the clinical and regulatory path towards Emergency Use Authorization for the treatment of COVID-19 patients,' said Dr. Dorit Arad, Founder & CTO of NLC Pharma, Todos Medical's 3CL science-based joint venture partner. 'The data produced in this study closely mirrors data we generated in an Observational Clinical study conducted in 2020. The recent emergence of the Omicron variant has been pushing healthcare systems to the brink of collapse. Tollovir could be an incredibly powerful tool to reduce death and stabilize patients faster, thereby reducing their recovery time from this debilitating disease. Tollovir will help flatten the curve by freeing up hospital capacity to see more patients and perform other more routine non-COVID related hospital treatments.'
'We are extremely pleased with the results from this clinical study in the hospital setting of our dual mechanism antiviral & anti-cytokine oral drug candidate Tollovir,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'We have already begun preparing manufacturing for commercial quantities of Tollovir so that we will be able to deliver shipments in jurisdictions where we expect to be granted accelerated Emergency Use Authorization (EUA), and are in the process of fine tuning our proposed Phase 2/3 clinical study protocol for hospitalized COVID-19 patients. The new protocol is the key document that will enable our regulator...
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