NEW YORK, May 7, 2018 /PRNewswire/ -- Neurotrope, Inc.
(NASDAQ: NTRP), a clinical-stage biopharmaceutical company
developing novel therapies for neurodegenerative diseases,
including Alzheimer's disease (AD), is announcing that Neurotrope
Bioscience, Inc., its wholly-owned operating subsidiary (the
"Company"), has completed the study design for its confirmatory
Phase 2 clinical trial in moderate to severe Alzheimer's
disease. The study was designed in consultation with a team
of experts in the AD field who are highlighted below.
This follow-on confirmatory clinical study will include 100
patients with moderate to severe AD (defined as a Mini Mental
State Exam 2 (MMSE-2) of 4-15). The primary efficacy endpoint
is defined as the change in the SIB score between the baseline and
the average of weeks 13 and 15. Patients will be randomized
1:1 Bryostatin-1 20ug vs. placebo. Patients on memantine, an
NMDA receptor antagonist, will be excluded unless they have been
off memantine for 30 days for the reason explained below by Dr.
Daniel Alkon, President and Chief
Scientific Officer of Neurotrope.
"The reason for excluding patients taking memantine from this
upcoming trial is based upon the data from our recently completed
study, which indicates that memantine blocked
bryostatin's observed improvement in cognition.
Both memantine and bryostatin engage the NMDA receptor.
Memantine directly blocks the NMDA receptor. In the absence
of memantine, bryostatin activates PKC, causing engagement of the
NMDA receptor. We believe this convergence of memantine
and PKC on the NMDA receptor helps explain why patients who
were not taking memantine during the study exhibited a consistent
cognitive improvement as measured by the Severe Impairment Battery
(SIB)."
The Company has assembled a team of expert advisors in the areas
of neurology, statistical analysis and clinical trial management in
AD. The statistical design and analysis team includes Dr.
Lee-Jen Wei, Professor of
Biostatistics at Harvard University,
and Dr. Richard Thompson, Senior
Scientist in the Department of Biostatistics at Johns Hopkins University. Both have extensive
experience in designing and analyzing clinical trials. The clinical
study team will include Dr. Martin
Farlow, MD, Professor Emeritus in the Department of
Neurology at Indiana University and
co-director of the AD Center at Indiana University. Dr.
Farlow has authored numerous peer reviewed scientific publications
devoted to the neurosciences. The clinical study team also
includes Dr. George Perry, Dean of
the College of Sciences, Professor of Biology, and the Semmes
Foundation Distinguished University Chair in Neurobiology at The
University of Texas at San
Antonio. Dr. Perry is the editor for numerous journals
including Editor-in-Chief for the Journal of Alzheimer's
Disease and a member of the Company's Board of Directors.
The Company has selected Worldwide Clinical Trials (Worldwide)
to conduct this confirmatory Phase 2 clinical
trial. Worldwide is a leading global clinical research
organization and the Company was very pleased with the way they
conducted enrollment and performed other duties in the recently
completed Phase 2 study. Neurotrope will recruit
approximately 30 US sites for participation in the upcoming
trial.
Dr. Alan Tuchman MD is serving as
Acting Chief Medical Officer for the Company and will oversee the
upcoming clinical trial. Dr. Tuchman was previously Chief Medical
Officer of Oncolytics Biotech Inc. He received his MD from the
University of Cincinnati, trained in
Neurology at The Mt Sinai School of Medicine in New York and completed a Fellowship in
Multiple Sclerosis at The Albert Einstein College of Medicine. He
is currently Clinical Professor of Neurology at New York Medical College. He received an MBA from
Columbia University School of Business
and has published and lectured extensively.
The Company's Chief Executive Officer Charles Ryan stated, "We are delighted the
confirmatory clinical study design is complete and the company is
preparing to initiate this important study with the direct
involvement of our clinical experts. The Company has the
capital on hand to complete this trial without the need to raise
additional funds. After completing a thorough analysis of the first
Phase 2 clinical study, we are very encouraged by the consistency
in the data. Bryostatin's unique mechanism of action
represents a potential pathway to treat many of the pathologic
consequences of Alzheimer's disease."
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,600 professionals
around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to
advancing medical science, Worldwide's goal is to change how
the world experiences CROs – in the best possible way. From early
phase and bioanalytical sciences through late phase, post-approval
and real-world evidence, Worldwide provides world-class,
full-service drug development services. With infrastructure and
talent spanning 60 countries, Worldwide executes
predictable, successful studies with operational excellence across
a range of therapeutic areas, including central nervous system,
cardiovascular, metabolic, immune-mediated inflammatory disorders
(IMID), oncology and rare diseases. For more information, visit
http://www.worldwide.com.
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 as a potential treatment for Fragile X Syndrome, Stroke,
Traumatic Brain Injury, and Niemann-Pick Type C disease and Rett
Syndrome—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 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 in
AD.
Please visit www.neurotropebioscience.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. These statements are subject
to the risk that further analyses of the Phase 2 data may lead to
different interpretations of the data than the analyses conducted
to date and/or may identify important implications of the Phase 2
data that are not reflected in these statements. Clinical trial
data are subject to differing interpretations, and regulatory
agencies, medical and scientific experts and others may not share
the Company's views of the Phase 2 data. 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. The Company does not undertake to
update these forward-looking statements.
Contact information:
Investors and Media
Jeffrey Benison, Director of Corporate Communications
Neurotrope Bioscience, Inc.
516.286.6099 (C) or 212.334.8709 (O)
jbenison@neurotropebioscience.com
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SOURCE Neurotrope, Inc.