Collaboration to Support Clinical Study of Bryostatin-1 in Leukemia and B-cell Lymphoma
Bryostatin-1 Upregulation of CD22 Offers Potential to Enhance CD22 Targeted Therapies, Including CAR-T cell therapy
Company Also Announces Completion of Safety Evaluation of Confirmatory, Phase 2, Placebo-Controlled Trial Evaluating Bryostatin-1 in Moderate to Severe Alzheimer's Disease
NEW YORK, Feb. 4, 2019 /PRNewswire/ -- Neurotrope Inc. (NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the research and clinical development of Bryostatin-1. Under the CRADA, Neurotrope will collaborate with the NCI's Center for Cancer Research, Pediatric Oncology Branch (POB) to develop a Phase I clinical trial testing the safety and toxicity of Bryostatin-1 in children and young adults with CD22 + leukemia and B-cell lymphoma. In the growing era of highly effective immunotherapies targeting cell-surface antigens (e.g., CAR-T cell therapy), and the recognition that antigen modulation plays a critical role in evasion of response to immunotherapy, the ability for Bryostatin-1 to upregulate CD22 may serve a synergistic role in enhancing the response to a host of CD22 targeted therapies.
Nirali N. Shah, M.D. of the NCI's POB will be Principal Investigator for the study, and Daniel Alkon, M.D., President and Chief Scientific Officer of Neurotrope, will serve as Co- Principal Investigator.
"We believe that this collaboration with the NCI's Center for Cancer Research provides further validation of the potential for Bryostatin-1 to affect disease pathways across a broad spectrum of indications," said Dr. Alkon. "In oncology, Bryostatin's potential capability to increase CD22 expression may enhance the development of newer and more effective therapies for children and young adults suffering with CD22-positive leukemia and B-cell lymphoma. The enthusiasm for this collaboration stems from the POB's long vested interest and experience targeting CD22, and we look forward to leveraging the expertise of Dr. Shah and her team to enhance our ongoing efforts to identify the most promising potential applications for Bryostatin-1."
Bryostatin-1 is a macrocytic lactone shown to increase CD22 expression in chronic lymphocytic leukemia. Under the CRADA, Bryostatin-1 is expected to be tested in the clinic to evaluate its ability to modulate CD22 in patients with relapsed/refractory CD22+ disease, while evaluating safety, toxicity and overall response.
"The initiation of our oncology collaboration with the NCI, coupled with the recent positive safety evaluation of our confirmatory Phase 2 AD trial, both demonstrate Bryostatin's broad potential," stated Dr. Charles Ryan, Chief Executive Officer of Neurotrope. "We enter 2019 with strong momentum clinically as well as operationally, with the successful completion of a financing in December 2018. We expect that 2019 will be a transformational year for Neurotrope as we move toward data in our AD program in the second half of the year, and seek out additional collaborations to fully explore the platform potential of Bryostatin-1."
Neurotrope also announced today the completion of the first safety evaluation of the Company's ongoing, placebo-controlled confirmatory Phase 2 trial evaluating Bryostatin-1 (20 µg) in 100 moderate to severe Alzheimer's disease patients not on memantine. The study's data safety and monitoring board found no safety concerns and recommended continuation of the trial as designed. Enrollment in the study, which was initiated in July 2018, is proceeding as planned, with data expected during the second half of 2019.
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 FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X. 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 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. 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, and on Form 10-Q for the quarter ended September 30, 2018. The Company does not undertake to update these forward-looking statements.
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Sam Martin and Ryan Baker