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Todos Medical Announces Enrollment Complete for Confirmatory Cohort of LymPro Alzheimer’s Blood Test Clinical Validation Trial vs. Amyloid PET

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Todos Medical, Ltd. (OTCQB: TOMDF) has announced the full enrollment of the 2nd cohort in a clinical trial led by Dr. Thomas Arendt at Leipzig University, evaluating the LymPro Alzheimer’s Blood Test in relation to amyloid PET imaging scores. Data from this trial is expected in summer 2022. The LymPro Test™, a potential early diagnostic for Alzheimer's, uses lymphocytes as indicators of neuronal function. With over 5.4 million Alzheimer's patients in the U.S., the disease incurs substantial healthcare costs, emphasizing the need for effective diagnostic tools.

Positive
  • Completion of full enrollment for the confirmatory cohort in the clinical trial for LymPro Test.
  • Expected data release in summer 2022 may advance Alzheimer's diagnostics.
Negative
  • None.

New York, NY, and Tel Aviv, ISRAEL, June 03, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its academic partner, Dr. Thomas Arendt at Leipzig University, has completed full enrollment for 2nd cohort (confirmatory) for the ongoing clinical trial to evaluate the concordance of the LymPro Alzheimer’s Blood Test scores with amyloid PET imaging scores. The Company expects the data to be released in the summer of 2022.

About LymPro

The Lymphocyte Proliferation Test (LymPro Test™) 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 surrogates for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.


About Alzheimer's Disease

According to the Alzheimer's Association, it is estimated that over 5.4 million people in the United States suffer from Alzheimer's disease. Over 500,000 patients are diagnosed annually, with nearly one-in-eight older Americans affected by the disease. Alzheimer's disease is the third leading cause of death in the United States. The cost of unpaid care in the United States is estimated at over $210 billion annually. Total payments for care are estimated at over $200 billion annually, including $140 billion in cost to Medicare and Medicaid. Alzheimer's expenditures in the United States are expected to exceed $1.2 trillion by 2050. There is no cure or effective treatment for Alzheimer's disease. Worldwide, about 35.6 million individuals have the disease and, according to the World Health Organization, the number will double every 20 years to 115.4 million people with Alzheimer's by 2050.


About Dr. Arendt's Research at Leipzig University

Dr. Thomas Arendt is Professor of Neuroscience at Leipzig University where he runs the Paul Flechsig Institute of Brain Research. He has a 30-year record in R&D of therapeutic and diagnostic strategies of neurodegenerative disorders and made several seminal contributions to therapeutic concepts of Alzheimer's disease, including stem cell therapy and modulating tumor suppressor genes. In the early 1980's, he was involved in identifying the degeneration of the cholinergic system in Alzheimer's disease laying the basis for today's only available treatment. He is one of the pioneers of the "cell-cycle theory" of Alzheimer's disease, which he developed towards a diagnostic and therapeutic concept.


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 novel coronavirus (COVID-19) test kits. The agreements cover 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. Additionally, 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.

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 the 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.

Todos Corporate Contact:
Daniel Hirsch
CFO
Todos Medical
917-983-4229 x 104
Dan.h@todosmedical.com

Todos Investor Relations Contact:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com


FAQ

What clinical trial did Todos Medical announce on June 3, 2022?

Todos Medical announced the full enrollment of the second cohort in a clinical trial evaluating the LymPro Alzheimer’s Blood Test.

What is LymPro Test™ and its significance?

The LymPro Test™ is a diagnostic blood test that assesses lymphocyte function, potentially aiding in early diagnosis of Alzheimer's disease, which has no effective treatment.

When is the data from the LymPro clinical trial expected?

The data from the LymPro clinical trial is expected to be released in summer 2022.

What is the current state of Alzheimer's disease in the U.S.?

Over 5.4 million people in the U.S. suffer from Alzheimer's, with significant annual healthcare costs exceeding $200 billion.

Who is leading the clinical trial for LymPro Test?

The trial is led by Dr. Thomas Arendt at Leipzig University.

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