NEWARK, N.J., Jan. 07, 2016 (GLOBE NEWSWIRE) -- Neurotrope, Inc. (OTCBB:NTRP) today announced the initiation of a Phase 2b clinical trial of lead candidate Bryostatin 1 for the treatment of Alzheimer’s Disease.
The Phase 2b trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of Bryostatin 1 in the treatment of moderately severe to severe Alzheimer’s Disease. The study, which plans to enroll 150 patients, is currently recruiting subjects at five trial sites in Florida, New Jersey, New York and Ohio. Neurotrope is engaging additional sites for the trial with a goal of over 30 participating sites.
“The initiation of this Phase 2b trial is an important milestone for Neurotrope and our lead compound, Bryostatin-1,” said Charles Ramat, President and CEO of Neurotrope. “In a Phase 2a study, Bryostatin proved to be safe and well-tolerated, and demonstrated activation of the PKC epsilon target, which Neurotrope believes results in a cascade effect resulting in synaptogenesis. Damaged synapses are a hallmark of Alzheimer’s Disease. We believe that Bryostatin represents a potential breakthrough in the treatment of this debilitating disease, and look forward to further evaluating its clinical validity in this study.”
The clinical trial will evaluate two different doses of Bryostatin (20 or 40µg) versus placebo, with a total of seven doses administered over 12 weeks. A second randomization will take place after the first 12 weeks of treatment, with patients in the Bryostatin arms to receive either a different dose of Bryostatin or the same dose. Patients in the placebo arm will be randomized to receive either Bryostatin (10µg) or placebo. The primary efficacy endpoint is based on Severe Impairment Battery (SIB) Scale, a benchmark assessment used extensively in severe Alzheimer’s drug trials. Secondary efficacy endpoints include Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI) and Mini-Mental State Exam (MMSE).
The Company expects to complete enrollment and report interim data from the study before the end of 2016, with the complete data set expected in the first half of 2017. Worldwide Clinical Trials has been retained as the contract research organization for this study.
Neurotrope BioScience, Inc., a wholly owned subsidiary of Neurotrope, Inc., is at the forefront of biotechnology companies having a focus on developing a novel therapy for the treatment of moderately severe to severe Alzheimer's disease. The scientific basis of our treatment is activation of Protein Kinase C isozymes ε and α by bryostatin, a natural product, which can result in enhancement of existing synapses, reduction of toxic amyloid generation, promotion of synaptogenesis, and enhancement of memory and learning, thus having the potential to improve cognitive function in Alzheimer's disease.
Neurotrope is also conducting preclinical studies of bryostatin as a treatment for Fragile X Syndrome and Niemann-Pick Type C disease, two rare genetic diseases for which only symptomatic treatments are currently available. The Food and Drug Administration has granted Orphan Drug Designation to Neurotrope for bryostatin as a treatment for Fragile X Syndrome.
NTRP has exclusively licensed technology from the Blanchette Rockefeller Neurosciences Institute for Alzheimer's disease and Fragile X Syndrome, has a world-wide, exclusive license with the Icahn School of Medicine at Mt. Sinai for Niemann-Pick Type C disease and is partnered with Stanford University to synthesize and find the next generation bryostatin – called bryologs.
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 proposed study and timing of initiation, and continued development of use of bryostatin for Alzheimer's disease and other cognitive diseases, and the Company's ability to list its common shares on a major stock exchange. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. 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. 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, the Company's inability to meet listing requirements for major stock exchanges, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2015. The Company does not undertake to update these forward-looking statements.
Please visit www.neurotropebioscience.com for further information.
For additional information, please contact:
The Ruth Group for Neurotrope Bioscience:
Lee Roth (Investors) / Kirsten Thomas (Media)
646-536-7012 / 508-280-6592
Source: Neurotrope BioScience