$AMBS Amarantus Appoints Michael T. Ropacki, PhD as Chief Medical Advisor for Alzheimer’s Blood Diagnostic LymPro Test Program
April 16, 2018
NEW YORK, April 16, 2018 (GLOBE NEWSWIRE) -- Via OTC PR Wire – Amarantus Bioscience Holdings, Inc. (OTC Pink:AMBS) (the "Company" or AMBS), a US-based JLABS-alumnus biotechnology holding company developing first-in-class orphan neurologic, regenerative medicine and ophthalmic therapies, as well as neurodiagnostics through its subsidiaries, today announced that it has appointed Michael T. Ropacki, PhD as Chief Medical Advisor to the Company's Alzheimer's Blood Diagnostic LymPro Test program. Dr. Ropacki will be responsible for helping oversee the further development of LymPro and assist the management team currently being recruited to lead the Company's Neurodiagnostics division in raising capital for the soon-to-be-formed Neurodiagnostics subsidiary. Dr. Ropacki brings over 20 years of clinical development experience to Amarantus as an industry clinical leader, investigator (academic and industry) and consultant.
"As Amarantus begins the process of advancing LymPro once again, I am excited to advise on the best development path to take forward given LymPro's unique standing in the Alzheimer's field as a dynamic flow cytometry assay measuring a set of cell cycle dysregulation markers that are directly related to the immune system," said Dr. Michael T. Ropacki, newly-appointed Chief Medical Advisor for the Alzheimer's Blood Diagnostic LymPro Test program. "The Food and Drug Administration's recently released draft guidance on Early Alzheimer's disease drug development reflects their current thinking on patient and clinical endpoint selection, as well as patient staging. This draft guidance emphasized the role that biomarkers play in the reliable identification and potential stratification of patients, as well as how biomarker changes may, in principle, serve as the basis for accelerated approval. This provides a unique opportunity, as LymPro has the potential to help fulfill the need for a reliable and cost-effective blood-based biomarker for patient identification and may also provide needed evidence on biomarker change over time."
Dr. Ropacki is the President of Strategic Global Research & Development (SG R&D), an S Corporation based in San Francisco, which collaborates with sponsors developing and executing Clinical Development Plans to maximize meaningful and productive regulatory interactions, as well as increase the probability of technical and regulatory success. Prior to his role at SG R&D, Dr. Ropacki was most recently Senior Vice President of Clinical Developmernt at MedAvante-ProPhase after its acquisition by WIRB Copernicus Group (WCG) in 2017. Before the WCG acquisition, he served as MedAvante's Vice President of Research & Development. Prior to his work at MedAvante, Dr. Ropacki held roles of increasing responsibility at Johnson & Johnson (NYSE:JNJ), his last as Director of Clinical Development, Neuroscience, Research and Development, for Janssen Research & Development. In this capacity he served as the Clinical Lead responsible for developing and leading the Cognitive Health in Aging Registry: Investigational, Observational and Trial studies in dementia research Prospective Readiness Cohort (CHARIOT-PRO) program and was responsible for assisting with the development and execution of other clinical programs within the neuroscience therapeutic area. Prior to that role, Dr. Ropacki served as Global Medical Affairs Leader, Head of Late-Stage Development at Janssen Alzheimer's Immunotherapy, LLC.
Dr. Ropacki serves as Co-Chair of a Scientific Advisory Group for the Innovative Medicines Initiative-European Prevention of Alzheimer's Dementia (IMI-EPAD) program, and he is a National Institute of Health (NIH) advisor to the National Institute on Aging (NIA), National Institute of Neurologic Disorders and Stroke (NINDS) and Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). He is a member of the Critical Path Institute's Critical Path for Alzheimer's Disease (CPAD) and digital Drug Development Tool (dDDT) Team. Previously, he was Co-Chair of the CAMD Preclinical Cognitive Outcome Assessment (COA) team working with the Food and Drug Administration's Drug Development Tool, COA Qualification Program. Dr. Ropacki authored or co-authored of dozens of published manuscripts and abstracts and was an Assistant Clinical Professor of Neurology at the Loma Linda University School of Medicine. Dr. Ropacki also previously served on the Steering Committee at the New York Academy of Sciences-Global Alzheimer's Platform (GAP), and Co-Leader of the GAP Registries-to-Cohort team.
Dr. Ropacki holds a bachelor degree Summa Cum Laude from University of Arizona and a master degree and doctorate from Texas Tech University. He completed his internship/residency at University of Oklahoma Health Sciences Center in Psychiatry and two post-doctoral fellowships at Brown University School of Medicine and UCLA School of Medicine, Neuropsychiatric Institute.
"Amarantus is privileged to have recruited a clinician with the impressive background and experience of Dr. Ropacki to our Alzheimer's blood diagnostic program," said Gerald E. Commissiong, President & CEO of Amarantus. "We continue to have strong reason to believe LymPro has the potential to become the gold standard in Alzheimer's diagnostics, and will need to work very closely with the FDA and industry to see this potential turn into reality. The FDA's recent guidance on the development of new products for Alzheimer's disease gives us hope that the agency will be receptive to new thinking about biomarkers and how we can approach including exciting exploratory markers such as LymPro more broadly into clinical trial designs, with the ultimate objective of having a significant impact on this devastating disease."
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 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. 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.
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