Neurotrope, In Consultation With Leading Neuroscientists, Completes the Study Design for its Confirmatory Phase 2 Trial in Advanced Alzheimer's Patients
Published: May 07, 2018
NEW YORK, May 7, 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 Neurotrope Bioscience, Inc., its wholly-owned operating subsidiary (the "Company"), has completed the study design for its confirmatory Phase 2 clinical trial in moderate to severe Alzheimer's disease. The study was designed in consultation with a team of experts in the AD field who are highlighted below.
This follow-on confirmatory clinical study will include 100 patients with moderate to severe AD (defined as a Mini Mental State Exam 2 (MMSE-2) of 4-15). The primary efficacy endpoint is defined as the change in the SIB score between the baseline and the average of weeks 13 and 15. Patients will be randomized 1:1 Bryostatin-1 20ug vs. placebo. Patients on memantine, an NMDA receptor antagonist, will be excluded unless they have been off memantine for 30 days for the reason explained below by Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope.
"The reason for excluding patients taking memantine from this upcoming trial is based upon the data from our recently completed study, which indicates that memantine blocked bryostatin's observed improvement in cognition. Both memantine and bryostatin engage the NMDA receptor. Memantine directly blocks the NMDA receptor. In the absence of memantine, bryostatin activates PKC, causing engagement of the NMDA receptor. We believe this convergence of memantine and PKC on the NMDA receptor helps explain why patients who were not taking memantine during the study exhibited a consistent cognitive improvement as measured by the Severe Impairment Battery (SIB)."
The Company has assembled a team of expert advisors in the areas of neurology, statistical analysis and clinical trial management in AD. The statistical design and analysis team includes Dr. Lee-Jen Wei, Professor of Biostatistics at Harvard University, and Dr. Richard Thompson, Senior Scientist in the Department of Biostatistics at Johns Hopkins University. Both have extensive experience in designing and analyzing clinical trials. The clinical study team will include Dr. Martin Farlow, MD, Professor Emeritus in the Department of Neurology at Indiana University and co-director of the AD Center at Indiana University. Dr. Farlow has authored numerous peer reviewed scientific publications devoted to the neurosciences. The clinical study team also includes Dr. George Perry, Dean of the College of Sciences, Professor of Biology, and the Semmes Foundation Distinguished University Chair in Neurobiology at The University of Texas at San Antonio. Dr. Perry is the editor for numerous journals including Editor-in-Chief for the Journal of Alzheimer's Disease and a member of the Company's Board of Directors.
The Company has selected Worldwide Clinical Trials (Worldwide) to conduct this confirmatory Phase 2 clinical trial. Worldwide is a leading global clinical research organization and the Company was very pleased with the way they conducted enrollment and performed other duties in the recently completed Phase 2 study. Neurotrope will recruit approximately 30 US sites for participation in the upcoming trial.
Dr. Alan Tuchman MD is serving as Acting Chief Medical Officer for the Company and will oversee the upcoming clinical trial. Dr. Tuchman was previously Chief Medical Officer of Oncolytics Biotech Inc. He received his MD from the University of Cincinnati, trained in Neurology at The Mt Sinai School of Medicine in New York and completed a Fellowship in Multiple Sclerosis at The Albert Einstein College of Medicine. He is currently Clinical Professor of Neurology at New York Medical College. He received an MBA from Columbia University School of Business and has published and lectured extensively.
The Company's Chief Executive Officer Charles Ryan stated, "We are delighted the confirmatory clinical study design is complete and the company is preparing to initiate this important study with the direct involvement of our clinical experts. The Company has the capital on hand to complete this trial without the need to raise additional funds. After completing a thorough analysis of the first Phase 2 clinical study, we are very encouraged by the consistency in the data. Bryostatin's unique mechanism of action represents a potential pathway to treat many of the pathologic consequences of Alzheimer's disease."
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide's goal is to change how the world experiences CROs - in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, Worldwide provides world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, Worldwide executes predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders (IMID), oncology and rare diseases. For more information, visit http://www.worldwide.com.
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.neurotropebioscience.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. The Company does not undertake to update these forward-looking statements.