Proposed Schedule III drug classification
expected to de-risk Cannasoul's cannabis research and potential
regulatory pathways
NEW
YORK, May 7, 2024 /PRNewswire/ -- Synaptogenix,
Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging
biopharmaceutical company developing therapeutics for
neurodegenerative disorders, today applauds the reported move by
the U.S. Drug Enforcement Agency (the "DEA") to recommend
reclassifying cannabis as a Schedule III drug, and announces
potential benefits of the rescheduling to its partner Cannasoul
Analytics ("Cannasoul"), founded by the Technion-Israel Institute
of Technology, in its discovery of cannabis-based therapeutics.
As reported in the press on April 30,
2024, the DEA will move to reclassify cannabis from a
Schedule I drug to a Schedule III under the Controlled Substance
Act on recommendation by the U.S. Department of Health and Human
Services. The reclassification would be the most significant change
in cannabis policy in 50 years. The rescheduling of cannabis would
significantly de-risk drug development for cannabis and derivatives
and enable companies to utilize well-defined pathways for
non-clinical and clinical testing, without specialized license
requirements. Reclassification would also enable cannabis drug
developers to provide straightforward estimates on timing and costs
through easier access to manufacturing facilities and research
sites for animal and human testing.
"We are pleased to learn about the DEA's proposed rescheduling,
which, if adopted as a final rule pursuant to the typical
rulemaking process, we believe would bring substantial benefits for
drug discovery companies engaged in clinical development for
cannabis-based therapeutics," said Dr. Alan Tuchman, Chief
Executive Officer of Synaptogenix. "Schedule III
classification would more closely align clinical development for
such therapies with the regulatory pathways for non-controlled
drugs. As clinical development becomes more mainstream, we believe
our partnership with Cannasoul has the potential to unlock even
greater value from owned assets and intellectual property as well
as our accessibility to the resources of Cannasoul's founder, the
Technion-Israel Institute of Technology."
The partnership with Cannasoul is exploring potential targets
for cannabinoid-based therapeutics in multiple indications
including solid tumors, migraine headache, inflammatory bowel
disease, and estrogen-related diseases. Any future clinical
development program involving any such targets is expected to be
conducted in the United
States.
About the Synaptogenix/Cannasoul Partnership
Synaptogenix acquired a 25% stake in Cannasoul in November 2023 in support of research and
development cannabinoid-based therapeutics. Cannasoul is known in
the field of analytical method development for pharmaceutical and
botanical research and development, and it holds unique expertise
in the field of cannabis and psilocybin research through its
analysis of more than 100 cannabinoids and 100 terpenes. Cannasoul
is founded by the Technion Research & Development Foundation,
the commercialization arm of the Technion-Israel Institute of
Technology, Israel's largest
center of applied research and a major source of innovation driving
the Israeli economy.
About Synaptogenix
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, in Alzheimer's disease. Preclinical studies have also
demonstrated bryostatin's regenerative mechanisms of action for the
rare disease Fragile X syndrome, and for other neurodegenerative
disorders such as 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. 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 the Company 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
800-811-5591
ir@synaptogen.com
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SOURCE Synaptogenix, Inc.
