NEW YORK, Aug. 13, 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 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.
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 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.
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 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.
Contact information:
Investors and Media
Sam Martin and Ryan Baker
Argot Partners
212-600-1902
Public Relations
Susan Roberts
sr@roberts-communications.com
202-779-0929
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SOURCE Neurotrope, Inc.