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Amarantus Forms Alzheimer's Disease Diagnostics Scientific Advisory Board

2015-01-22 07:00 ET - News Release

SAN FRANCISCO and GENEVA, Jan. 22, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics in neurology, and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has established an Alzheimer's disease Diagnostics Scientific Advisory Board (SAB) and appointed three internationally-renowned specialists in Alzheimer's disease (AD) and neurological disorders, Paula T. Trzepacz, M.D., Jeffrey L. Cummings, M.D., Sc.D., and Robert A. Stern, Ph.D., as its first members. The company expects to expand the SAB during the first half of 2015.

"I am pleased to announce the appointments of such an esteemed trio of Alzheimer's researchers to Amarantus Diagnostics' inaugural Scientific Advisory Board," said Gerald E. Commissiong, President & CEO of Amarantus. "Following last week's announcement of our exclusive option agreement with Georgetown University to license their suite of markers for Alzheimer's disease, adding exciting lipidomic and exosome modalities to our cell cycle dysregulation LymPro Test® blood diagnostic, we are now positioned to corner the entire Alzheimer's blood-based diagnostics marketplace, a potential $3 billion market opportunity. We are beginning with the $150 million Investigational Use Only (IUO) market by offering the world's most extensive suite of markers to the pharmaceutical industry.

"I am particularly impressed with the extensive neurobiology and neurotherapeutic experience of our inaugural members in Alzheimer's disease given that we are now actively engaged in the marketing of our blood-based markers to the IUO market. They will be of great assistance as we work with pharmaceutical companies to improve their Alzheimer's therapeutics development programs, which have had a disappointing 99.6% failure rate, in large part due to an inability to properly screen patients prior to study enrollment, as well as difficulty in monitoring the effectiveness of drug activity on disease-relevant biomarkers. Currently, the gold standard for Alzheimer's diagnosis remains autopsy confirmation, with some incremental improvement such as recent advances in PET imaging. Ultimately, we are endeavoring to dramatically shift that paradigm, to the benefit of patients, their families, and world healthcare systems, by providing a simple and cost-effective tool to physicians that will greatly enhance their confidence in making an Alzheimer's diagnosis and assist caregivers in managing this devastating disease with therapies we will have helped shepherd through clinical development," concluded Mr. Commissiong.

Dr. Trzepacz is an international expert in delirium, with extensive psychiatric clinical experience in the assessment and management of neurological disorders in Geriatrics Psychiatry, Neuropsychiatry and Psychosomatic Medicine including delirium, dementias and traumatic brain injury. She is a Clinical Professor of Psychiatry at Indiana University School of Medicine, on the Clinical Faculty at the University of Mississippi Medical School, and an Adjunct Professor of Psychiatry at Tufts University School of Medicine. Dr. Trzepacz has been a principal investigator or research collaborator for numerous international and NIH-funded projects, including a genomics study of post-operative delirium at Duke University Medical School and research in ICU delirium at Indiana University School of Medicine.

Most recently Dr. Trzepacz was a Senior Medical Fellow at Eli Lilly and Company ("Lilly") focused on amyloid assessment in evaluation of cognitive impairment and the scientific exploration of the relationship of a variety of biomarkers across the continuum of Alzheimer's disease. Her role at Lilly neuroscience also included registration experience, Phase 2 through Phase 4 clinical programs, and leading the Phase 2 program on mibampator for agitation and aggression in AD. She serves on the editorial boards of the Journal of Neuropsychiatry and Clinical Neurosciences, General Hospital Psychiatry, and Psychosomatics. Additionally, Dr. Trzepacz has published and lectured extensively on delirium and neuropsychiatry. She was President of the Academy of Psychosomatic Medicine (APM) from 2004-2005, and President of the American Neuropsychiatric Association (ANPA) from 2009-2011, and is a Fellow of both organizations. Dr. Trzepacz is the recipient of a number of honors and awards, including the 1997 Research Award from APM, and was listed in four editions of Best Doctors in America.

"The lack of tools to positively identify Alzheimer's, and distinguish it from other neurodegenerative conditions, adds to both the devastation of this disease and the inability to develop good treatment options," said Dr. Trzepacz. "I am delighted to join Amarantus as it seeks to develop a suite of AD diagnostics, across multiple biomarkers, which is an area on which I focused a great deal of my career. I am hopeful we can make a real difference in the diagnosis of these terrible conditions, which in turn, could lead to more effective therapeutics."

Dr. Cummings is a leading expert in neuropsychiatry of neurologic disorders, biomarkers for neurodegenerative diseases, and an experienced clinical trialist with expertise in trial design and analysis, global trial implementation, and trial outcome measures. He is Director, Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada and Cleveland, Ohio. Additionally he is the Camille and Larry Ruvo Chair of the Neurological Institute of Cleveland Clinic and Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Dr. Cummings is the author of the Neuropsychiatric Inventory (NPI) which is the most commonly used tool for clinical trials characterizing behavioral disturbances in dementia syndromes.

"I am excited to be one of the first members of this important advisory board at Amarantus. Advancing new biomarkers for AD, especially readily available peripheral markers, is a key area in advancing AD research and care," remarked Dr. Cummings. "Consistent and reliable early detection of AD would be a major turning point for addressing AD's devastating effects on patients and their families. I look forward to the development of a standard-of-care evaluation tool for early detection of patients across a spectrum of truly debilitating neurologic diseases and disorders."

Dr. Cummings' research and leadership contributions in the field of Alzheimer's disease have been recognized through the Henderson Award of the American Geriatrics Society (2006), the Research Award of the John Douglas French Alzheimer's Research Foundation (2008), and the Ronald and Nancy Reagan Research Award of the national Alzheimer's Association (2008). In 2010, he received the Legacy Award from the Ticki Wilkerson-Kassel Movement Therapy Foundation and was honored by the American Association of Geriatric Psychiatry with their Distinguished Scientist Award. In 2011, he was awarded an honorary Doctor of Science by his alma mater, The University of Wyoming and was recognized for his "Lifetime of Medical Achievement" in Healthcare Headliners, a special publication of Las Vegas Inc. magazine (September 2011).

Dr. Cummings was featured in GQ (June 2009), Vogue (September 2009) and Vanity Fair (September 2009) as a "Rockstar of Science." Dr. Cummings was formerly Professor of Neurology and Psychiatry at UCLA, director of the Mary S. Easton Center for Alzheimer's Disease Research at UCLA, and director of the Deane F. Johnson Center for Neurotherapeutics at UCLA. He is past president of the Behavioral Neurology Society and of the American Neuropsychiatric Association. Dr. Cummings has authored or edited over 38 books and published 650 peer-reviewed papers.

Dr. Stern's major focus of research expertise is on the long-term effects of repetitive brain trauma in athletes, including the neurodegenerative disease, Chronic Traumatic Encephalopathy (CTE). He is a Professor of neurology, neurosurgery, anatomy and neurobiology at Boston University School of Medicine, Director of the Clinical Core of the Boston University Alzheimer's Disease Center, and Director of Clinical Research for the CTE Center at Boston University. Both the NIH and the Department of Defense have funded his work on developing methods of detecting and diagnosing CTE during life, as well as examining potential genetic and other risk factors for this disease. Dr. Stern's other major areas of funded research include the assessment and treatment of Alzheimer's disease, the cognitive effects of chemotherapy in the elderly, thyroid-brain relationships, and driving and dementia. He has published on various aspects of cognitive assessment and is the senior author of many widely used neuropsychological tests, including the Neuropsychological Assessment Battery (NAB).

"Amarantus has a truly remarkable opportunity with LymPro, but, more importantly, this opportunity extends more broadly to additional diagnostics as well. I am pleased to participate on the diagnostic advisory board as we explore its tremendous impact on AD and in other neurodegenerative diseases," said Dr. Stern. "LymPro can improve upon the accuracy of AD diagnosis during life, providing clinical investigators the ability to enroll appropriate patients into research studies. LymPro's use as a diagnostic tool for clinical research has the potential to change the paradigm of pharmaceutical clinical studies in AD and ultimately other neurological related trials."

Dr. Stern was formerly on the faculty at University of North Carolina, where he was the Associate Director of the NIMH-funded Mental Health Clinical Research Center, and Director of the Neurobehavioral Assessment Core. He was also on the faculty at Brown Medical School, where he was Associate Professor of Psychiatry and Neurology, as well as Director of Neuropsychology and the Memory and Cognitive Assessment Program at Rhode Island Hospital. Dr. Stern has received several NIH and other national grants and has published over 250 journal articles, chapters, and abstracts. He is a Fellow of both the American Neuropsychiatric Association and the National Academy of Neuropsychology. He is on several editorial boards and serves on the Medical and Scientific Advisory Boards of the MA/NH Chapter of the Alzheimer's Association and the Sports Legacy Institute. Dr. Stern is also a member of the Mackey-White Traumatic Brain Injury Committee of the NFL Players Association. He has testified before the U.S. Senate Special Committee on Aging and frequently appears in national and international print and broadcast media for his work on CTE and AD.

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, 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.

On January 12, 2015, AMBS announced the acquisition of DioGenix, Inc., a specialized neuro-diagnostics company, and owns the rights to MSPrecise®, a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation. On January 15, 2015, AMBS executed a one-year exclusive option agreement with Georgetown University to enter into a license for the patent rights related to certain blood based biomarkers for memory loss and Alzheimer's disease jointly owned by Georgetown University and University of Rochester. For further information please visit www.Amarantus.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

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