NEW YORK, July 11, 2018 /PRNewswire/ -- Neurotrope, Inc. (NASDAQ: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), is announcing that it has established its Scientific Advisory Board (SAB) comprised of experts in the fields of AD and other Neurological diseases.
Dr. Martin R. Farlow, MD, Professor Emeritus in the Department of Neurology at Indiana University and co-director of the Alzheimer's Disease Center at Indiana University, will serve as Chairperson of the SAB. Dr. Farlow has authored numerous peer reviewed scientific publications and was lead investigator of the trial showing the first time memantine, when added to donepezil in combination, demonstrated a statistically significant benefit as compared to donepezil alone. A more complete description of Dr. Farlow's accomplishments is included below.
"We are delighted to have leading authorities in the field of Alzheimer's research and clinical design and analysis agree to join our Scientific Advisory Board," said Neurotrope CEO Charles Ryan. "We believe that this team of accomplished leading academicians will enhance our company's ability to accelerate the development of bryostatin in Alzheimer's Disease and other neurological disorders, expand our pipeline with the right strategic assets, and advance our goal to bring a novel therapeutic to the market to treat patients with AD and other neurological disorders."
"Bryostatin has a new and unique mechanism of action with the potential to perhaps increase cognition, as opposed to simply slowing the progression of Alzheimer's disease," said Dr. Martin Farlow, Scientific Advisory Board Chair. "I look forward to working with Neurotrope and the distinguished members of Neurotrope's Scientific Advisory Board to develop a platform with a novel mechanism of action to advance therapies for AD."
"The newly established SAB is a key strategic resource for Neurotrope, providing scientific expertise and guidance to our team as we advance the clinical development of bryostatin in AD while continuing to assess the use of bryostatin to potentially treat other diseases," stated Dr. Ryan.
Scientific Advisory Board Chairperson & Members
Martin R. Farlow, (Chairperson) MD, Professor Emeritus in the Department of Neurology at Indiana University and co-director of the Alzheimer's Disease Center at Indiana University, will serve as chair of the SAB. Dr. Farlow received his medical degree from Indiana University School of Medicine. Following graduation, he completed an internship in Internal Medicine and a residency in Neurology.
Dr. Farlow's research focuses on clinical trials of investigational drugs for the treatment of AD and related dementias and has been the lead investigator for several major studies including tacrine, donepezil and rivastigmine. Dr. Farlow has authored numerous peer reviewed scientific publications and lectured on the topics of aging, dementia, and Alzheimer's disease at more than 300 meetings, conferences, and hospitals/medical schools throughout the world. He is a reviewer for numerous scientific journals and on the editorial boards of MedLink and Current Alzheimer Research. Dr. Farlow is a member of many professional associations including the American Academy of Neurology and the American Neurological Association. He is also a founding member of both the American Society of Experimental Neurotherapeutics and the International Society for CNS Clinical Trials and Methodology.
Paul Coleman PhD, has been an Associate at the University of Arizona (UA) McKnight Brain Institute since 2010 and a Research Professor at the UA Biodesign Institute since 2015. In 2007, Dr. Coleman was appointed Professor Emeritus at the University of Rochester Medical Center. Since 1988, Dr. Coleman has served as Editor-in-Chief for the journal Neurobiology of Aging and is currently Editor Emeritus and an Advisory Editor. Dr. Coleman received an AB in Psychology (magna cum laude) from Tufts University and a PhD in Physiology and Psychology from the University of Rochester. Following his PhD, Dr. Coleman was supported by the National Institute of Neurological Disorders and Stroke as a Special Fellow at Johns Hopkins School of Medicine.
Dr. Coleman has been a pioneering investigator of the pathologic basis of AD. His work has provided insight into how synaptic network loss and dysfunction are correlated with cognitive decline. His early work examined dynamic processes of synaptic plasticity. At Cold Spring Harbor Laboratory, he developed a method for profiling gene expression in single cells in vitro which he subsequently applied to the postmortem human brain using both mRNA and in situ hybridization methods. Dr. Coleman published one of the first studies profiling gene expression of single neurons in the Alzheimer versus normal human brain. Dr. Coleman is the recipient of numerous awards including the LEAD Award: Leadership and Excellence in Alzheimer's disease from NIH/NIA in 1990 to 1999 (one of 12 ever given), an Honorary Professorship from the Jilin Medical College in Jilin China in 1988 and a Pioneer Award: from the National Alzheimer's and Related Disorders Association (1999 – 2004).
Daniel F. Hanley Jr. MD, has been a Professor of Neurology, Neurosurgery and Anesthesia and Critical Medicine at Johns Hopkins Medicine since 1996. He is a graduate of Williams College and received his medical degree from Cornell University Medical College. Dr. Hanley has board certification in internal medicine, neurology and psychiatry.
Dr. Hanley is a leading expert on brain injury and has received more than 20 basic research grants, predominantly from the National Institute of Health. He received the Alexander Humboldt Research Prize for his accomplishments in brain injury research, where he has extensive clinical trials experience. Dr. Hanley also received the 2018 Distinguished Investigator Award from the American College of Critical Care Medicine. He is the Vice Chairman of the Board of Directors of the National Stroke Association and the Jeffrey and Harriett Legum Professor of Acute Care Neurology and Director of Brain Injury Outcomes Program. Serving on the board of Directors of the National Stroke Association, Dr. Hanley leads the Johns Hopkins – Tufts Trial Innovation Center an NIH supported center dedicated to improving the efficiency and quality of clinical trials. He has published more than 300 articles in peer-reviewed journals. Dr. Hanley is a member of the American Academy of Neurology, American Neurological Association, Neurocritical Care Society and the Society of Critical Care Medicine. He served as associate editor for Stroke, Critical Care Medicine, and on the board of International Journal of Stroke. He also serves as a reviewer for multiple peer-reviewed journals.
Marwan Sabbagh, MD, is the new director of the Cleveland Clinic Lou Ruvo Center for Brain Health and he has dedicated his entire career to finding a cure for Alzheimer's and other age-related neurodegenerative diseases. Dr. Sabbagh earned his undergraduate degree from the University of California-Berkeley and his medical degree from the University of Arizona in Tucson. Dr. Sabbagh received his residency training in neurology at Baylor College of Medicine and completed his fellowship training in geriatric neurology and dementia under renowned AD experts, Leon Thal, M.D., and Robert Katzman, M.D., at the University of California, San Diego School of Medicine. Dr. Sabbagh is a board-certified neurologist and geriatric neurologist.
Dr. Sabbagh is a leading investigator for many prominent national Alzheimer's prevention and treatment trials, including Alzheimer immunotherapy studies. He is on the editorial board of the Journal of Alzheimer's Disease, Alzheimer's Disease and Associated Disorders, Current Alzheimer's Research, American Journal of Alzheimer's and Dementia and BMC Neurology. He has authored and co-authored more than 300 medical and scientific articles on Alzheimer's research. Dr. Sabbagh authored The Alzheimer's Answer—the book's forward was written by Justice Sandra Day O'Connor—and The Alzheimer's Prevention Cookbook: 100 Recipes to Boost Brain Health. Dr. Sabbagh edited Palliative Care for Advanced Alzheimer's and Dementia: Guidelines and Standards for Evidence Based Care, and Geriatric Neurology. Dr. Sabbagh is also Editor-in-Chief of the Neurology and Therapy Journal, an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality preclinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, including devices.
Lee Jen Wei, PhD, is a tenured Professor of Biostatistics at Harvard University since 1991. He was the co-director of the Bioinformatics Core at the Harvard School of Public Health. Dr. Wei obtained his B.S in mathematics from Fu-Jen University (Taiwan) and his PhD in statistics from the University of Wisconsin–Madison.
In 1986, Dr. Wei was elected as a Fellow of the American Statistical Association. Professor Wei was named "Statistician of the Year" in 2007 by the Boston Chapter of the American Statistical Association. The American Statistical Association gave him the Wilks Memorial Award in 2009 "for statistical methods used in clinical trials," which is one of the most prestigious awards among all the international statistical societies. Professor Wei has developed and published a number of novel quantitative methods for analyzing data from experimental and observational studies. Specifically, Dr. Wei has published many papers on monitoring drug and device safety and related topics. The resulting procedures have been utilized for various drug and device regulatory evaluations involving safety issues. His extensive experience in quantitative science for making inferences about the drug and device safety is readily applicable to the general industry product safety issues. Professor Wei's scholarly writings include over 130 articles in peer-reviewed academic journals. He is responsible for developing numerous novel statistical methods for practitioners. Many of these methods have been included in the most commonly used statistical packages. He has additionally served on the editorial boards of a number of statistical journals and is an elected Fellow of the American Statistical Association and Institute of Mathematical Statistics.
Neurotrope is at the forefront of developing a new approach to combating AD and other neurodegenerative diseases. The Company's world-class science offers the potential to realize a paradigm shift to overcome one of today's most challenging clinical problems finding a way to slow or even prevent the progression of AD.
In addition to the Company's Phase 2 trial of Bryostatin-1 in advanced AD, Neurotrope has also conducted preclinical studies of bryostatin as a potential treatment for Fragile X Syndrome, Stroke, Traumatic Brain Injury, and Niemann-Pick Type C disease and Rett Syndrome—rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X Syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs in AD.
Please visit www.neurotrope.com for further information.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. These forward-looking statements include statements regarding the Phase 2 study and further studies, and continued development of use of Bryostatin-1 for Alzheimer's dementia and other cognitive diseases. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company's views of the Phase 2 data. There can be no assurance that the clinical program for Bryostatin-1 will be successful in demonstrating safety and/or efficacy that we will not encounter problems or delays in clinical development, or that Bryostatin-1 will ever receive regulatory approval or be successfully commercialized. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Additional factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, the Company's patent portfolio, the Company's inability to expand the Company's business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of the Company's raw materials, existing or increased competition, stock volatility and illiquidity, and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and on Form 10-Q for the quarter ending March 31, 2018. The Company does not undertake to update these forward-looking statements.
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SOURCE Neurotrope, Inc.