Neurotrope Completes Licensing Agreement for Accelerated Synthesis of Alzheimer’s Drug Bryostatin-1
Creates potential for an economical and commercially viable supply of Bryostatin-1
NEW YORK, Jan 30, 2017 /PRNewswire/ — Neurotrope, Inc. (OTCQB: NTRPD), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer’s disease, announced today that it has signed a licensing agreement with Stanford University for an accelerated synthesis of bryostatin-1. Prior to this synthetic route, bryostastin-1 had to be isolated from tons of natural sources to obtain grams of the drug.
Bryostatin-1 is a complex marine natural product with 11 chiral centers, which made the development of a synthetic method especially difficult. Animal studies have shown that bryostatin crosses the blood brain barrier. Neurotrope has based its Phase 2a, expanded access program, and its ongoing Phase 2 Alzheimer’s disease (AD) clinical trials, (top-line data anticipated to be announced in April, 2017), on extensive pre-clinical pharmacology and efficacy studies, led by Dr. Daniel Alkon, President and Chief Scientific Officer. These animal studies have demonstrated bryostatin-1 efficacy for restorative synaptogenesis, prevention of neuronal death, and anti-amyloid, anti-tau metabolism via the activation of PKC epsilon pathways via bryostatin-1 activation.
The restorative therapeutic potential of bryostatin-1 and bryostatin- like activators, may be fundamental to a number of neuro-degenerative pathways and neurologic indications including AD, Fragile X syndrome (FXS), stroke, traumatic brain injury (TBI), and depression. Consequently, the need for an economical, commercial supply has increased.
Stanford University chemists, Drs. Paul Wender and Barry Trost, together with Dr. Garry Keck of the University of Utah, developed the initial routes to total synthesis of bryostatin-1.
The drug that Neurotrope has licensed has many potential benefits, including cost, time and manufacturing risk reduction.
“Having access to a highly efficient synthesis of bryostatin-1 is taking the next step to making it commercially available,” stated Dr. Susanne Wilke, Chief Executive Officer of Neurotrope.
“We are delighted to further pursue this important synergy between world-class chemistry and what we believe to be pioneering basic and clinical neuroscience,” stated Dr. Alkon, Neurotrope’s President and Chief Scientific Officer. “Neurotrope can now plan for bryostatin-1 availability based upon the work of Dr. Wender, who has also developed a number of bryostatin derivatives called Bryologues that we have previously licensed.”
Previously, bryostatin-1 was produced via a lengthy purification process. The National Cancer Institute (NCI) has, nevertheless, generously supplied bryostatin-1 for all of Neurotrope’s clinical trials to date. The NCI had extracted bryostatin-1 from Bugula Neritina, a sea sponge that houses the bacteria that excrete the natural product. From tons of the Bugula Neritina collected at that time, the NCI was able to extract 18 grams of bryostatin-1. The NCI also initially investigated bryostatin-1 in a number of cancer indications, creating a large safety database for bryostatin-1 of over 1,500 patients who received the drug in those clinical trials.
Neurotrope is at the forefront of developing a novel therapy to treat and potentially reverse moderate to severe Alzheimer’s disease and other neurodegenerative diseases. The Company’s world-class science is a paradigm shifting approach that treats some of the underlying causes of 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 in mouse Alzheimer’s disease models was demonstrated to result in repair of damaged synapses as well as synaptogenesis, the induction of new neuronal networks, reduction of toxic beta-amyloid generation, prevention of neuronal death, and enhancement of memory and learning, thus having the potential to improve cognition and behavior in Alzheimer’s disease.
Neurotrope is conducting a Phase 2 trial of bryostatin in the treatment of moderate to severe Alzheimer’s disease, as well as preclinical studies of bryostatin-1 as a treatment for Fragile X Syndrome, Niemann-Pick Type C disease and Rett Sydrome, three 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 undergone testing in over 1,500 people establishing a large safety database.
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 Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. The Company does not undertake to update these forward-looking statements.
Please visit www.neurotropebioscience.com for further information.
For additional information, please contact:
Neurotrope Bioscience, Inc.
Jeffrey Benison, Director of Corporate Communications
212.334.8709 or 516.286.6099