NEW YORK, Feb. 4, 2021 /PRNewswire/ -- Synaptogenix,
Inc. (OTC: SNPX) announced today that it has received its
first batch of synthetic Bryostatin. The Company has an exclusive
licensing agreement with Stanford
University ("Stanford") for
synthetic Bryostatin for all neurologic indications, as well as a
supply agreement in place with Bryologyx, Inc. as previously
announced. To date, Synaptogenix has relied upon supply of
Bryostatin, derived from natural sources, from the National Cancer
Institute of Health.
Dr. Alan J. Tuchman, CEO of
Synaptogenix, added, "Our ability to receive synthetic supply of
Bryostatin for the first time puts us in position to expand
development initiatives, notably the development of an orally
deliverable compound, which requires as much as five times the
supply. This is a milestone and building block with which we
believe can accelerate growth opportunities for the Company going
forward. The availability of increased drug supply will also enable
us to look to commence additional informative trials to supplement
the data we expect to generate from our NIH supported Phase 2 trial
in moderate to severe Alzheimer's Disease."
"Our new supply of synthetic Bryostatin allows Synaptogenix to
conduct trials to potentially treat a broad range of
neurodegenerative disorders including Multiple Sclerosis, Stroke,
Parkinson's disease, Traumatic Brain Injury, and Fragile X /
Autistic Spectrum Disorder," stated Daniel
L. Alkon, MD, President and CSO.
About Synaptogenix, Inc.
Synaptogenix is a
clinical-stage biopharmaceutical company that has historically
worked to develop novel therapies for neurodegenerative diseases.
Synaptogenix has conducted clinical and preclinical studies of its
lead therapeutic candidate, Bryostatin-1, for advanced Alzheimer's
disease, and preclinical studies for rare diseases such as Fragile
X syndrome, Niemann-Pick Type C disease, and Rett syndrome,
multiple sclerosis, stroke, and traumatic brain injury. The U.S.
Food and Drug Administration has granted Orphan Drug Designation to
Synaptogenix 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.
Additional information about Synaptogenix, Inc. may be found on
its website: www.synaptogen.com.
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, the available supply of drug product 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 its
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 its 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. The
Company does not undertake to update these forward-looking
statements.
Contact information:
Investors and Media
Neil
Cataldi
ncataldi@synaptogen.com
Robert Weinstein
Chief Financial Officer
Synaptogenix, Inc.
rweinstein@neurotrope.com
View original
content:http://www.prnewswire.com/news-releases/synthetic-bryostatin-available-to-expand-neurodegenerative-indication-trials-301222274.html
SOURCE Neurotrope, Inc.