NEW YORK, Feb. 4, 2019 /PRNewswire/ -- Neurotrope Inc.
(NASDAQ: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.
About Neurotrope
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.
Forward-Looking Statements
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.
Contact information:
Investors and Media
Sam Martin and Ryan Baker
Argot Partners
212-600-1902
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SOURCE Neurotrope Inc.