The Importance of Alternative Healthcare Options Grows in the Midst of the Pandemic

NEW YORK, April 20, 2021 /PRNewswire/ -- While the pandemic continues to be a heavy burden on the economy and the healthcare system, there are several developments that point to positive signs in the fight against the virus. Perhaps most importantly, the vaccine rollout has been effective in several countries and generally speaking, social distancing and PPEs have helped reduce the numbers of infected and keep the economy afloat, even if only partially. Still, global concerns over new cases remain. For example, James Quincey, Chief Executive Officer of Coca-Cola, indicated to analysts in a recent conference call not to expect a straight-line recovery from this point, noting that confirmed cases globally hit a high last week. And while some countries such as the U.S. and the U.K. are making rapid progress on vaccinations and are beginning to reopen, Mr. Quincey said that "you've got countries that are going in the exact opposite direction with cases shooting up and more levels of lockdowns." Todos Medical Ltd. TOMDF, Koninklijke Philips N.V. PHG, Pfizer Inc. PFE, Dynavax Technologies Corporation DVAX, Sorrento Therapeutics, Inc. SRNE

With the pandemic continuing to spread throughout the United States and the world, the need for alternative healthcare options is becoming increasingly clear. For instance, the telehealth sector includes a wide range of technological segments under its umbrella. Specifically, technologies such as telemedicine, robots, and chatbots are being deployed to help gather information, reassure the population, treat patients, make diagnoses, and even prepare future vaccines. In the meantime, mass testing remains crucial for governments to properly implement preventative measures throughout this pandemic. For example, in January, McSwain Union Elementary School in Northern California started testing teachers and then students for the virus, even if they weren't showing symptoms.

Todos Medical Ltd. TOMDF announced yesterday breaking news regarding 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.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com."

For our latest "Buzz on the Street" Show featuring Todos Medical Ltd., recent corporate news, please head over to: https://www.youtube.com/watch?v=1eLAxmVVPPg 

Koninklijke Philips N.V. PHG announced last year that the U.S. FDA had issued an Emergency Use Authorization (EUA) for Philips' IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85, for use in the US during the COVID-19 health emergency [1]. These patient monitoring solutions support infection-control protocols and remotely provide critical patient information for caregivers, capabilities that are much needed when caring for hospitalized COVID-19 patients. Philips' IntelliVue Patient Monitors MX750/MX850 and IntelliVue Active Displays AD75/AD85 received CE mark in 2019 and are already being used in hospitals across Europe. The EUA allows Philips to start delivering the new remote patient monitoring solution to hospitals in the U.S., and the company is committed to submitting a 510(k) to FDA for this acute care solution in the course of 2020.

Pfizer Inc. PFE and BioNTech SE announced on March 31st, that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. These are topline results from a pivotal Phase 3 trial in 2,260 adolescents. "We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."

Dynavax Technologies Corporation DVAX and the Coalition for Epidemic Preparedness Innovations (CEPI) announced earlier this year that they have entered into an agreement to support the supply of Dynavax's CpG 1018 advanced adjuvant to be used in approved COVID-19 vaccines developed by CEPI grantees. Dr. Richard Hatchett, CEO of CEPI commented: "A critical goal of CEPI's response to COVID-19 is to support development, manufacturing and distribution of vaccines to end the acute phase of the pandemic by the end of 2021. Through our partnership with Dynavax, we hope to enable the development and faster supply of adjuvanted COVID-19 vaccines and ensure equitable access to them globally."

Sorrento Therapeutics, Inc. SRNE announced earlier this year major progress in the development of COVISHIELD through the license of intellectual property developed by the scientific team at the Icahn School of Medicine at Mount Sinai ("Mount Sinai"). Sorrento and Mount Sinai have entered into an Exclusive License Agreement for a collection of antibodies having SARS-CoV-2 neutralizing properties that were developed by Mount Sinai. The license also contemplates Sorrento and Mount Sinai pursuing future collaborations in developing humanized monoclonal antibodies for therapeutic applications. Sorrento Chairman and CEO, Dr. Henry Ji, commented, "We are pleased with the excellent COVISHIELD antibody candidates identified thus far, and we at Sorrento are committed to rapidly developing the COVISHIELD cocktail against known and emerging COVID-19 variants of concern. Sorrento looks forward to future collaborations with the respected research capabilities of Mount Sinai centered on the development of innovative anti-viral and anti-cancer therapeutic candidates."

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