Amarantus Commences Launch of Proprietary Alzheimer's Blood Diagnostic LymPro Test(R) to Pharmaceutical Industry for Use in Clinical Trials
SAN FRANCISCO and GENEVA, Dec. 22, 2014 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced the launch of the company's LymPro Test®, a leading, proprietary Alzheimer's blood diagnostic, to the pharmaceutical industry for investigational use in clinical development programs. The commercialization of LymPro follows the successful completion of the requisite 'Fit-for-Purpose' assay validation conducted at Icon Central Laboratories.
"We have built significant value in our LymPro program over the past two years, and the initiation of our launch to the pharmaceutical industry represents a critical milestone for Amarantus," commented Gerald E. Commissiong, President & CEO of Amarantus. "We believe LymPro is poised to establish a market leading position as the first fundamental disease-biology based, blood biomarker test for Alzheimer's disease in the world, an area with significant unmet need and for which there has recently been a great deal of interest in the mainstream media."
"LymPro is now available to pharmaceutical companies for investigational use in the recruitment of subjects in their Alzheimer's disease clinical studies," commented Colin Bier, Amarantus' corporate advisor and LymPro program lead. "We believe this diagnostic blood test has the potential to be an extremely valuable tool to assist pharma companies in selecting subjects to enroll in their Alzheimer's therapeutic clinical development programs and mitigating the risk of enrolling subjects into clinical trials who do not meet the criteria of Alzheimer's disease. LymPro will have a significant positive impact on the overall outcome of their trials, ultimately benefiting the millions of patients and their families suffering from this horribly debilitating disease."
LymPro is the only Alzheimer's blood diagnostic with two independent peer-reviewed published articles (Stieler et al, NeuroReport, 2001 and Stieler et al, Neurobiology of Aging 2012). Amarantus announced further replication of this original work in October 2014, when the company reported interim data demonstrating high sensitivity and specificity in identifying Alzheimer's vs. non-Alzheimer's under two separate assay conditions. Amarantus anticipates reporting final top-line data of its LP-002 clinical study to assess LymPro's predictive value in diagnosing mild to severe Alzheimer's disease patients by the end of 2014. Amarantus intends to publish data from this study, as well as previously reported data, at prestigious scientific congresses and in peer-reviewed journals throughout the course of 2015. This additional data will then be useful in making a determination regarding which version of LymPro (Version 1 or Version 2) Amarantus will launch under the CLIA designation for marketing to the broader medical community in the United States in 2015.
About Alzheimer's disease
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 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 $1.4 trillion by 2050.
About LymPro Test®
The Lymphocyte Proliferation Test (LymPro Test®) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes to withstand an external 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. LymPro is unique in the use of peripheral blood lymphocytes (PBLs) as a surrogate for neuronal cell function, suggesting a common immune-based relationship between PBLs and neurons in the brain.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company developing treatments and diagnostics for diseases associated with neurodegeneration and protein misfolding-related apoptosis. AMBS has licensed Eltoprazine ("Eltoprazine"), a phase 2b ready small molecule indicated for Parkinson's disease Levodopa induced dyskinesia and Adult ADHD. AMBS has an exclusive worldwide license to the Lymphocyte Proliferation test ("LymPro Test®"), which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig, for Alzheimer's disease and owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor ("MANF") and is developing MANF-based products as treatments for brain and ophthalmic disorders. AMBS also owns intellectual property for the diagnosis of Parkinson's disease ("NuroPro") and the discovery of neurotrophic factors ("PhenoGuard™"). In November 2014, AMBS entered into an exclusive option agreement with Lonza Walkersville, Inc., a subsidiary of Lonza Group Ltd., to acquire Cutanogen Corporation, a subsidiary of Lonza Walkersville, to develop Engineered Skin Substitute (ESS-W), an autologous skin replacement product for the treatment of Stage 3 and Stage 4 intractable severe burns. For further information please visit www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
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