Todos Medical Announces Positive Alzheimer's Biomarker Clinical Data from LymPro vs. Amyloid PET Interim Analysis
REHOVOT, Israel, July 15, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro diagnostic company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, such as Alzheimer's disease (AD), today announced positive results from a pre-specified interim analysis of 20 subjects from an ongoing 40-subject outpatient study evaluating the relationship between LymPro Test™ (LymPro) scores with amyloid PET imaging scores. LymPro measures cell cycle dysfunction in peripheral lymphocytes. The data revealed strong and statistically significant correlation between LymPro scores and amyloid PET neuroimaging cSUVR scores (r = -0.849; p = 0.00000216).
The study is being conducted under the direction of Dr. Thomas Arendt at the University of Leipzig in Germany, with mild cognitive impairment (MCI) and dementia patients evaluated in the clinic of the Neurobiological Research group in the Department of Psychiatry and Psychotherapy. Todos Medical expects Leipzig to complete patient enrollment in the second half of 2019, and to disclose full results in a future scientific conference. The study is being sponsored by Todos Medical’s joint venture company, Breakthrough Diagnostics, Inc. (Breakthrough). Todos Medical has exercised its option to acquire full ownership of Breakthrough from Amarantus Bioscience Holdings, Inc., and is in the process of completing the acquisition.
Todos is sponsoring the Investacure Cure Coin Awards Reception at 7pm PT today at The Association, 110 East 6th Street, Los Angeles, CA 90014 during the Alzheimer’s Association International Conference (AAIC). Company executives will be available to speak with media and others during the event.
“While the pre-specified interim analysis findings are preliminary, these strong correlative LymPro Test results suggest an underlying association between cell cycle dysfunction (CCD) as measured in lymphocytes with the histological evidence of CCD occurring in the brains of Alzheimer’s patients. This intermediary correlation with amyloid plaque pathology measured ante mortem by amyloid PET neuroimaging is encouraging, considering the documented neuropathological concurrence of CCD and β-amyloid pathology in AD patients. Given that previous research shows LymPro distinguishes healthy older controls from MCI and AD patients, and that this study population represents routine clinical practice, we are very excited by these findings,” said Dr. Paula Trzepacz, incoming Chief Medical Officer for Todos Medical.
“If confirmed at study completion, these results suggest that LymPro will be a useful adjunctive biological diagnostic test that adds confidence to a clinical AD diagnosis. Importantly, LymPro would be a convenient and more cost-effective approach to pre-qualify patients enrolling in Alzheimer’s clinical trials. Such enrichment of the study population screened for trial inclusion could drastically reduce the time and cost of recruiting patients for Alzheimer’s therapeutic studies – a key need for the biopharmaceutical industry,” she added. “We look forward to completing enrollment of the remaining 20 subjects to confirm these encouraging results as we prepare to launch LymPro as an investigational use only (IUO) biomarker assay for patient selection in clinical trials.”
About Todos Medical Ltd.
Todos Medical Ltd., headquartered in Rehovot, Israel, is a cancer in-vitro-diagnostic company engaging in the development of a series of blood tests for the early detection of a variety of cancers and has initiated the development of blood tests for neurodegenerative disorders, such as Alzheimer's disease, through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. The company has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Breakthrough Diagnostics is developing the Alzheimer’s blood diagnostic LymPro Test®.
For more information, the content of which is not part of this press release, please visit http://www.Todosmedical.com.
About Breakthrough Diagnostics, Inc.
Breakthrough Diagnostics, Inc. is a joint venture owned by Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) (80.01%) and Todos Medical Ltd. (19.99%). Breakthrough has been assigned the intellectual property and other rights to LymPro Test®, a diagnostic blood test for Alzheimer’s disease, as well as rights to other neurological diagnostics testing intellectual property. Todos Medical has provided Amarantus with notice of Todos’s decision to exercise its exclusive option to acquire the 80.01% of Breakthrough Diagnostics that it currently does not own.
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.
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.
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Released July 15, 2019