お知らせ • Aug 31
Todos Announces Notice of Allowance from Uspto for Patent Application Covering Use of Compositions in Tollovid™? and Tollovir™? Ingredients Todos Medical Ltd. announced that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance for NLC Pharma’s patent application entitled "Compounds for Treating a Coronavirus Infection” prosecuted from the groundbreaking work of Dr. Dorit Arad. The Notice of Allowance covers the use of key compounds contained in the ingredients in Tollovid™ and Tollovir™ (NLC-V-01, NLC-001 or 3CL-001). The allowed claims are directed, among other things, to the administration of compounds to a subject to inhibit activity of the 3CL protease, inflammation and autophagy, and to treat coronavirus infection. The USPTO's assessment pertains solely to patentability, while approvability as a disease treatment falls solely within the jurisdiction of the United States Food & Drug Administration (US FDA). Tollovid, a unique 3CL protease inhibition dietary supplement, is not approved by the US FDA for the diagnosis, treatment, prevention or cure of any disease including COVID, acute and/or chronic coronavirus infections, or Long COVID. Tollovir, an anti-cytokine and 3CL protease inhibitor therapeutic candidate that has successfully completed a Phase 2 clinical trial in the treatment of hospitalized COVID-19 patients, is not approved by the US FDA to diagnose, treat, prevent, or cure any disease including COVID, acute and/or chronic coronavirus infections or Long COVID. Tollovid and Tollovir are manufactured with distinct raw materials, such that the key ingredients of Tollovir are separate and distinct from the key ingredients in Tollovid, resulting in separate end products from different key raw materials that contain patent pending compounds. お知らせ • May 17
Todos Medical Ltd. announced delayed 10-Q filing On 05/16/2023, Todos Medical Ltd. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. お知らせ • Feb 15
Todos Medical Initiates Validation Plan for PCR-based Avian Influenza A (H5N1, Bird Flu) Test at CLIA/CAP Testing Lab Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has initiated a validation plan for PCR-based Avian Influenza A (H5N1, bird flu) human testing. Under the plan, the Company will validate commercial and internally developed H5N1 PCR reagents and launch the most sensitive test. The H5N1 PCR test is being developed as a Laboratory Developed Test (LDT). The currently circulating strain of H5N1, which has been the most transmissible and most deadly to date, has successfully crossed over from birds to mammals, with various land and sea animals, including skunks, foxes, raccoons, bears, minks, mountain lions, sea lions, seals and dolphins having confirmed H5N1 infection at death. Over 58 million poultry birds have been affected, and cases in birds have been reported in every state in the US. There is concern among leading scientists that the current strain of H5N1 could mutate to become more transmissible towards humans. Ecuador reported the first human case of H5N1 for 2023 in a 9-year old girl in January. When H5N1 does infect humans, historical data gathered shows it has a 56% mortality rate. お知らせ • Oct 15
Todos Medical CLIA/CAP Lab Provista Submits Emergency Use Authorization Application for Monkeypox PCR Test to US FDA Todos Medical Ltd. announced that its CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed an Emergency Use Authorization (EUA) application with the US Food & Drug Administration (FDA) for its PCR MonkeyPox Test. The EUA application was submitted for lesion-based PCR. The sensitivity achieved for the currently available lesion-based laboratory-developed test (LDT) is 0.95 viral copies per reaction (0.095 copies/ul). お知らせ • Sep 28
Todos Medical Announces USPTO Trademark Notice of Allowance for 3Cl Protease Biomarker Diagnostics Tollotest™ Todos Medical Ltd. announced that its majority-owned joint venture 3CL Pharma Ltd. received a Notice of Allowance issued by the USPTO for the Company’s proprietary SARS-CoV-2 3CL protease (Main protease, Mpro, Nsp5) diagnostic TolloTest™ that was developed to detect and quantify the presence of 3CL protease in human tissue samples. TolloTest has been initially validated in upper respiratory tract (swab) samples and can provide PCR-like accuracy with convenience similar to that of a rapid antigen test. The Company previously announced positive data on TolloTest in hospitalized and outpatient settings such as skilled nursing facilities and schools. The test is designed to quantify 3CL protease, which is being measured for correlation with infectiousness and potentially a key feature of the SARS-CoV-2 viral persistence pathology in Long COVID. TolloTest is a potential companion biomarker test for the Company’s 3CL protease inhibitor dietary supplement Tollovid and a companion diagnostic for its Phase 2 asset Tollovir for hospitalized COVID. TolloTest can be commercialized as a rapid point-of-care test in single use and mass screening formats, as an at-home test for single use, and as a laboratory developed test (LDT) for use in high complexity CLIA labs and mobile labs for patient monitoring. The global COVID-19 diagnostics market size is expected to reach USD 50.1 billion by 2030, according to a new report by Grand View Research Inc. The market is expected to expand at a CAGR of 7.7% from 2022 to 2030. The Company expects significant innovation will be required to improve the accuracy of point of care diagnostics and TolloTest could play a key role in area. お知らせ • Sep 15
Todos Medical Initiates Validation Plan for PCR-Based Polio Testing at CLIA/Cap Laboratory Provista Diagnostics Todos Medical Ltd. announced that its CLIA/CAP-certified laboratory Provista Diagnostics has initiated a validation plan for PCR-based polio testing. The Company intends to validate multiple PCR assays for polio, including wastewater testing with ultra-high sensitivity. Low viral load diagnostic tests will be developed for early diagnosis and will be available for multiplexing with other PCR panels. The global bioinformatics market was valued at $13.2 billion in 2021 according to Precedence Research and is expected to grow at a CAGR of 16.3% to $45.6 billion by 2030. This market includes data management and production, data warehousing, and data mining for life sciences, academia, and applied testing. A much smaller subset of this market is the Wastewater-based epidemiology (WBE) which surveils large population clusters in an unobtrusive manner. The routine testing can be used to capture data on underreported viral illnesses, enabling the early detection of pathogens in a community. There are 58 countries gathering this data in order to enact policy decisions. During the COVID-19 surges, wastewater patterns were analyzed and became predictive of the subsequent outbreaks. The average site typically screens weekly or twice weekly and gets reimbursed up to $940 per site per week according to some recent awards from the CDC. 