Synthetic Bryostatin Available to Expand Neurodegenerative Indication Trials
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.
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.
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