NEWARK, N.J., Nov. 20, 2014 /PRNewswire/ -- Neurotrope, Inc. (OTCQB: NTRP) announced today that the last patient has been dosed in its Phase 2a clinical trial of Bryostatin-1 for the treatment of patients with Alzheimer's disease (AD). The trial is being conducted under an Investigational New Drug (IND) application filed by the Company's licensor, the Blanchette Rockefeller Neuroscience Institute (BRNI).
Bryostatin is a potent modulator of the enzyme protein kinase C epsilon (PKCe). In preclinical in vivo models, this effect has been shown to play an important role in slowing or reversing AD and restoring cognition, memory and motor skills.
As previously reported, Neurotrope's Phase 2a study was initiated in late July 2014. The primary objective of the study is to assess safety and tolerability of a single dose of Bryostatin-1. Secondary objectives include the preliminary assessment of efficacy using a variety of clinical measures, including an assessment of improvements in cognition. Management expects final results of the study to be available in January 2015.
Commenting on today's news, Charles S. Ramat, Chief Executive Officer and President of Neurotrope, stated, "Dosing of the last patient in this Phase 2a study marks an important milestone for patients with Alzheimer's disease and our company." Paul Freiman, Chairman of the Company, added, "Given the millions of patients and families affected by this debilitating condition and the overwhelming need for new, novel therapies that may be able to arrest the progression of the disease, we are as committed as ever to pushing forward with the development of Bryostatin-1."
Management notes that it is currently developing a randomized, double-blind placebo controlled, multiple-dose clinical trial to further assess efficacy and safety of Bryostatin-1 in the treatment of AD.
Bryostatin is a natural product produced by a marine invertebrate organism called Bugula neritina and is isolated from organic matter harvested from the ocean. Several variations of this complex product have been achieved in recent years in various academic chemistry laboratories, including bryostatin derivatives being developed through an exclusive license with Stanford University and the existing license agreement with BRNI. These approaches may represent alternative sources of drug supply.
Neurotrope Bioscience Inc, the operating subsidiary of Neurotrope, Inc., was formed in October 2012 principally to license, develop and commercialize various novel therapeutic and diagnostic technologies from BRNI. Neurotrope's pipeline, under its license from BRNI, includes the drug candidate, bryostatin, for the treatment of Alzheimer's disease, and a minimally invasive, diagnostic biomarker analysis system which would assess the presence of Alzheimer's in patients. In addition, Neurotrope has a world-wide, exclusive license agreement with the Icahn School of Medicine at Mount Sinai to utilize its proprietary information and data package for the use of Bryostatin-1 in the treatment of Niemann-Pick Type C Disease, a rare disease, mostly of children who are afflicted with Alzheimer-like symptoms. Also, the Company, under its BRNI license, has the rights to pursue treatments for a number of orphan diseases, including Fragile X Syndrome. The Company's preclinical and clinical efforts are focused on the development of conventional small molecules that are extraordinarily potent in the activation of the enzyme PKCe, which has been shown to play a central role in the regrowth or repair of nervous tissues, cells or cell products.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements include statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of commercially viable pharmaceuticals, Such forward- looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of 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 contribute to the inaccuracy of the forward-looking statements 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 inability to expand the Company's business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, volatility in the price of the Company's raw materials, existing or increased competition, results of arbitration and litigation, 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 fiscal year ended December 31, 2013 and Quarterly Report on Form 10-Q for the fiscal nine months ended September 30, 2014. The Company does not undertake to update these forward-looking statements.
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SOURCE Neurotrope, Inc.