REHOVOT, Israel, and NEW YORK, June 16, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Todos Medical Ltd. (OTCQB: TOMDF), an in vitro diagnostics company focused on the distribution of a comprehensive suite of solutions for the screening and diagnosis of COVID-19 and the development of blood tests for the early detection of cancer and Alzheimer’s disease, today announced that it has entered into an exclusive worldwide distribution agreement with Israel-based NLC Pharma to commercially develop its patented virus-focused 3C Protease diagnostic platform for the diagnosis of COVID-19.
“3C Protease quantitation presents a unique approach to viral replication monitoring, and could prove to be a significant tool in the fight against COVID-19,” said Jorge Leon, PhD, Senior Medical Advisor to Todos.
The 3C Protease is a novel target for COVID-19 drug development. It has properties that make it a strong saliva-based biomarker candidate for viral load measurement because it binds to full length viral RNA and is required prior to coronaviruses exiting host cells before going to infect other cells, and it secretes into the saliva for measurement of viral load. Because only full-length RNA is detected, it overcomes potential limitations of technologies that detect viral fractions, such as antigen testing and certain polymerase chain reaction (PCR)-based tests that often yield false positives post-infection. Todos intends to develop an At-Home (or Onsite) COVID-19 diagnostic 3C Protease-based test kit for use as a diagnostic for COVID-19, using existing cell phone camera technology and proprietary software to complete the data analysis. The companies will work together towards filing an Emergency Use Authorization (EUA) application with the FDA in the United States and the Ministry of Health in Israel. NLC previously developed working prototypes from its 3C Protease platform for rapid detection of HRV (common cold), HMV (viral meningitis), and SARS.
“As we build Todos into a niche provider of COVID-19 testing solutions to laboratories, healthcare providers and policy makers worldwide, we have identified areas in the diagnostic testing space that require significant innovation, including the development of an ‘Active Infection’ test that is convenient to use and can be deployed at the point of screening prior to gaining access to transmission-risky settings,” said Gerald E. Commissiong, President & CEO of Todos. “We believe this technology gives us a proprietary foothold in a space that is screaming for novel solutions to overcome the biological limitations of current approaches. As we begin the commercialization of our COVID-19 molecular and antibody portfolios, this proprietary technology will give us a marketing advantage as customers look to align with long-term partners. The imbedded cell phone analysis technology will allow for privacy-compliant integration with various contact tracing, telehealth, and employer-based health solutions coming to market.”
“We are excited to have an opportunity to bring our 3C Protease technology into the marketplace to address the COVID-19 pandemic,” said Dr. Dorit Arad. “3C Protease offers the first platform for rapid detection of SARS-nCoV-2 in saliva, at the reproduction stage of the virus, and will developed to be used in airports and public places, as well as in the convenience of your home to help stop the spread of the COVID-19 pandemic.”
About the SARS-CoV-2 Coronavirus (COVID-19)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries worldwide. COVID-19 is the disease caused by SARS-CoV-2.
About NLC-Pharma
NLC Pharma was created in February 2020 to manifest the IP and products that have been the subject of R&D by Dr. Dorit Arad for over 30 years, aimed to be utilized to treat and prevent the spread of the COVID-19 pandemic. NLC platform is focused on inhibiting and detecting the 3C protease that is responsible for viral reproduction. It includes a very effective natural product 3C protease inhibitors, to be used as a supplement to treat and prevent corona, and a 3 minute detection kit, that is the subject of the collaboration with Todos.
About Todos Medical Ltd.
Headquartered in Rehovot, Israel, 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 and are currently in a pre-commercial study with its distribution partner Orot+ (a division of Luces-Orot). Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the second quarter of 2020.
Through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Todos is also actively involved with the development of blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. Todos expected to complete the remaining unowned interest in Breakthrough in the second quarter of 2020.
Todos recently entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The Company has entered into distribution agreements with multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed Corona Diagnostics, LLC, a strategic collaboration with Emerald Organic Products, Inc. (OTC: EMOR), to support telemedicine and virtual pharmacy aspects of the commercialization of its COVID-19 return to work testing programs in the US.
For more information, please visit https://www.todosmedical.com/
Forward-looking Statements
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
Investor and Corporate Contact:
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
(212) 838-3777
kgolodetz@lhai.com
Corporate Contact:
Daniel Hirsch
Todos Medical
(347) 699-0029
Dan.h@todosmedical.com
“3C Protease quantitation presents a unique approach to viral replication monitoring, and could prove to be a significant tool in the fight against COVID-19,” said Jorge Leon, PhD, Senior Medical Advisor to Todos.
The 3C Protease is a novel target for COVID-19 drug development. It has properties that make it a strong saliva-based biomarker candidate for viral load measurement because it binds to full length viral RNA and is required prior to coronaviruses exiting host cells before going to infect other cells, and it secretes into the saliva for measurement of viral load. Because only full-length RNA is detected, it overcomes potential limitations of technologies that detect viral fractions, such as antigen testing and certain polymerase chain reaction (PCR)-based tests that often yield false positives post-infection. Todos intends to develop an At-Home (or Onsite) COVID-19 diagnostic 3C Protease-based test kit for use as a diagnostic for COVID-19, using existing cell phone camera technology and proprietary software to complete the data analysis. The companies will work together towards filing an Emergency Use Authorization (EUA) application with the FDA in the United States and the Ministry of Health in Israel. NLC previously developed working prototypes from its 3C Protease platform for rapid detection of HRV (common cold), HMV (viral meningitis), and SARS.
“As we build Todos into a niche provider of COVID-19 testing solutions to laboratories, healthcare providers and policy makers worldwide, we have identified areas in the diagnostic testing space that require significant innovation, including the development of an ‘Active Infection’ test that is convenient to use and can be deployed at the point of screening prior to gaining access to transmission-risky settings,” said Gerald E. Commissiong, President & CEO of Todos. “We believe this technology gives us a proprietary foothold in a space that is screaming for novel solutions to overcome the biological limitations of current approaches. As we begin the commercialization of our COVID-19 molecular and antibody portfolios, this proprietary technology will give us a marketing advantage as customers look to align with long-term partners. The imbedded cell phone analysis technology will allow for privacy-compliant integration with various contact tracing, telehealth, and employer-based health solutions coming to market.”
“We are excited to have an opportunity to bring our 3C Protease technology into the marketplace to address the COVID-19 pandemic,” said Dr. Dorit Arad. “3C Protease offers the first platform for rapid detection of SARS-nCoV-2 in saliva, at the reproduction stage of the virus, and will developed to be used in airports and public places, as well as in the convenience of your home to help stop the spread of the COVID-19 pandemic.”
About the SARS-CoV-2 Coronavirus (COVID-19)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses can be transmitted between animals and people and evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (SARS-CoV-2) was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China, and additional cases have been found in a growing number of countries worldwide. COVID-19 is the disease caused by SARS-CoV-2.
About NLC-Pharma
NLC Pharma was created in February 2020 to manifest the IP and products that have been the subject of R&D by Dr. Dorit Arad for over 30 years, aimed to be utilized to treat and prevent the spread of the COVID-19 pandemic. NLC platform is focused on inhibiting and detecting the 3C protease that is responsible for viral reproduction. It includes a very effective natural product 3C protease inhibitors, to be used as a supplement to treat and prevent corona, and a 3 minute detection kit, that is the subject of the collaboration with Todos.
About Todos Medical Ltd.
Headquartered in Rehovot, Israel, 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 and are currently in a pre-commercial study with its distribution partner Orot+ (a division of Luces-Orot). Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the second quarter of 2020.
Through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Todos is also actively involved with the development of blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. Todos expected to complete the remaining unowned interest in Breakthrough in the second quarter of 2020.
Todos recently entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The Company has entered into distribution agreements with multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed Corona Diagnostics, LLC, a strategic collaboration with Emerald Organic Products, Inc. (OTC: EMOR), to support telemedicine and virtual pharmacy aspects of the commercialization of its COVID-19 return to work testing programs in the US.
For more information, please visit https://www.todosmedical.com/
Forward-looking Statements
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
Investor and Corporate Contact:
Kim Sutton Golodetz
LHA Investor Relations
Senior Vice President
(212) 838-3777
kgolodetz@lhai.com
Corporate Contact:
Daniel Hirsch
Todos Medical
(347) 699-0029
Dan.h@todosmedical.com
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