-Analysis in Journal, Trends in Pharmacological Sciences, Outlines Bryostatin's Transformative Potential in Combating Alzheimer's Disease-
NEW YORK, Aug. 13, 2019 /PRNewswire/ -- Neurotrope, Inc. (NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that an article highlighting the synaptic deficiency hypothesis was published online in Trends in Pharmacological Sciences. This article presents an overview of the previous nonpharmacological interventions and pharmacological agents, including Bryostatin, that target synaptic functions in order to improve cognitive functions against AD-related memory impairment. The publication emphasizes that restoring synaptic functions should be considered as one of the major therapeutic goals in the treatment of AD patients.
"Alzheimer's disease, the leading disorder of memory impairment in our aging population, is increasing at an alarming rate and clinical trials targeting neurotoxic amyloid beta have consistently failed to produce therapeutic effects on memory function in AD patients," said Dr. Daniel Alkon, Neurotrope's Chief Scientific Officer. "Leveraging decades of work on the protein kinase C (PKC) - BDNF pathway in memory storage at NIH and other leading institutions, bryostatin (not a statin for lowering cholesterol) uses a novel mechanism of action to generate new, mature synaptic connections and prevent neuronal death in AD models."
"Our confirmatory Phase 2 trial is based on clinical data from our previous exploratory Phase 2 trial, which showed significant improvements in Severe Impairment Battery (SIB) scores for patients in the 20µg Bryostatin-1 dose group not on memantine," Dr. Alkon continued. "We look forward to reporting top-line data from this confirmatory Phase 2 study during the third quarter of 2019, which could be a critical point of validation for the regenerative potential of bryostatin as a treatment for patients with moderate to severe AD."
The article, entitled Neuro-regeneration Therapeutic for Alzheimer's Dementia: Perspectives on Neurotrophic Activity, explores the synaptic deficiency hypothesis and therapeutic strategies that have potential to restore synaptic numbers reduced by neurodegeneration. Brain-derived neurotrophic factor (BDNF) plays essential roles in cell proliferation, neurogenesis, cognition, and synaptic integrity. The BDNF signaling pathways in the brain are regulated by specific protein kinase C (PKC) isoforms. The PKC-BDNF signaling pathways play essential roles in maintaining synaptic functions and structures and a variety of memory tasks. PKC ε activation with Bryostatin-1 promotes BDNF expression and secretion, and synaptogenesis, and provides protective effects against a variety of neurotoxic factors such as amyloidosis, tauopathy, apoptosis, neuroinflammation, and oxidants.
Neurotrope is currently evaluating Bryostatin-1 (20 µg) in 108 moderate to severe AD patients not on memantine in a confirmatory, randomized, double-blind, placebo-controlled Phase 2 clinical trial. In March 2019, the Company announced dosing of the final patient in the study and, in July 2019, the Company concluded data collection. Top-line data from this study are expected during the third quarter of 2019.
Full Article Available Online
The complete publication in the Trends in Pharmacological Sciences: CellPress Reviews can be accessed here: https://www.cell.com/trends/pharmacological-sciences/fulltext/S0165-6147(19)30145-2 (through a paywall), or the publication with open access will be posted on Neurotrope's corporate website when available.
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-1 as a potential treatment for rare diseases and brain injury, including Fragile X syndrome, multiple sclerosis, stroke, Niemann-Pick Type C disease, Rett syndrome, and traumatic brain injury. The U.S. Food and Drug Administration 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.
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 AD 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. 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 Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2018, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. The Company does not undertake to update these forward-looking statements.
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