REHOVOT, Israel and NEW YORK, April 08, 2019 (GLOBE NEWSWIRE) — Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, such as Alzheimer’s disease, and Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS), a diversified life sciences holding company with subsidiaries in neurology, regenerative medicine and ophthalmology, today announced that pursuant to their joint venture Breakthrough Diagnostics Inc.’s (“Breakthrough”) amended and restated license agreement (the “License”) and related sponsored research agreement (the “SRA”) with Germany’s Leipzig University to the support the development and commercialization of the immune-based Alzheimer’s blood diagnostic LymPro Test 2.0 (“LymPro”), Leipzig University has completed the LymPro PET 1 study. . The SRA is supporting completed (LymPro PET 1) and an ongoing confirmatory clinical trial (LymPro PET 2) to evaluate the concordance of LymPro with amyloid PET imaging, CSF tau and other important Alzheimer’s biomarkers.
Breakthrough is expecting to receive the full data set from the LymPro PET 1 study in the coming weeks, and is expecting the enrollment for the LymPro PET 2 study to be completed shortly thereafter to allow for a full evaluation of both studies in 2019.
“LymPro’s unique position as a dynamic assay that measures peripheral blood-based cellular immune dysfunction makes it a potentially game-changing assay for Alzheimer’s drug development,” said Dr. Herman Weiss, President & CEO of Todos. “Todos will now evaluate the full range of data generated from LymPro Test 2.0’s clinical trials that will inform our US and international regulatory strategy for LymPro commercialization. We will be focused initially on deploying this assay to support pharmaceutical trials, while generating the necessary additional data to support US and Global market authorization.”
Todos has the right to exercise its exclusive option to acquire full control of Breakthrough in exchange for an additional issuance of Todos shares to Amarantus.
- AAIC 2015 Poster Presentation of LymPro Test LP-002 Clinical Data
- Breakthrough Alzheimer’s Diagnostics Scientific Advisory Board
- LymPro Test CLIA Validation complete
- Dr. Ropacki Appointed Chief Medical Advisor for Alzheimer’s Blood Diagnostic LymPro Test
About LymPro Test
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. 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.
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 (OTCQB: TMDF) (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 owns an exclusive option to acquire the 80.01% of Breakthrough Diagnostics that it currently does not own.
About Todos Medical Ltd.
Todos Medical Ltd. (OTCQB: TOMDF), an Israeli company headquartered in Rehovot, is a cancer in-vitro-diagnostic (“IVD”) company engaged in the development of a series of blood tests for the early detection of a variety of cancers and neurodegenerative disorders, such as Alzheimer’s disease. 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 (“PBMC”) 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 are CE marked in the EU.
Additionally, the company’s joint venture entity owns the exclusive rights to the Lymphocyte Proliferation Test (LymPro Test), 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.
For more information, the content of which is not part of this press release, please visit http://www.Todosmedical.com.
About Amarantus Bioscience Holdings, Inc.
Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. AMBS’ wholly-owned subsidiary Elto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson’s disease levodopa-induced dyskinesia, Alzheimer’s aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. AMBS acquired the rights to the Engineered Skin Substitute program, a regenerative medicine-based approach for treating severe burns with full-thickness autologous skin grown in tissue culture that is being pursued by AMBS’ wholly-owned subsidiary Cutanogen Corporation. AMBS’ wholly-owned subsidiary MANF Therapeutics, Inc. owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (“MANF”). MANF Therapeutics, Inc. is developing MANF-based products as treatments for brain and ophthalmic disorders. MANF was discovered by the Company’s Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS’ proprietary discovery engine PhenoGuard. The Company also re-acquired rights to the Alzheimer’s blood diagnostic LymPro Test ®, MSPrecise™ and NuroPro.
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, neither Todos Medical nor Amarantus undertakes 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 and Amarantus, please refer to their reports filed from time to time with the U.S. Securities and Exchange Commission.
Amarantus Investor and Media Contact:
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Source: Amarantus Bioscience Holdings, Inc.