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Synaptogenix Announces Changes to Scientific Advisory Board in Preparation for Phase 2 Data

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Synaptogenix (Nasdaq: SNPX) announced changes to its Scientific Advisory Board (SAB) ahead of the Phase 2b clinical trial data for Bryostatin-1 in advanced Alzheimer's patients. The SAB includes experts such as Dr. George Perry and Dr. Marwan Sabbagh, who will guide the company's therapeutic developments. CEO Alan Tuchman emphasized the critical expertise of the SAB in preparing for the upcoming data. The company has also received Orphan Drug Designation for Bryostatin-1 targeting Fragile X syndrome, enhancing its research credentials.

Positive
  • Formation of a highly qualified Scientific Advisory Board to guide clinical development.
  • Upcoming Phase 2b data could provide critical insights into Bryostatin-1's efficacy.
  • Orphan Drug Designation for Bryostatin-1 for Fragile X syndrome supports its development viability.
Negative
  • None.

Conference Call to be held Tuesday, July 26th at 4:30pm ET

NEW YORK, July 26, 2022 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("the Company"), a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced changes to its Scientific Advisory Board (SAB) in preparation for Phase 2 data from its Phase 2b clinical trial of Bryostatin-1 for patients suffering from advanced and moderately severe Alzheimer's disease (AD).  The SAB is comprised of industry and academic leaders in science and drug development and will be instrumental in the further development of the Company's regenerative therapies across AD, Fragile X syndrome, and multiple sclerosis (MS).

The SAB will be chaired by Dr. George Perry, who will serve along with Dr. Marwan Sabbagh, Dr. Paul Coleman, Professor Robert Howard, and Dr. Zaven Khachaturian.

"We are extremely pleased to have assembled this world class Scientific Advisory Board. The expertise and experience within this group will be invaluable as we prepare for Phase 2 data later this year, as well as the next steps we will take to advance the development of our regenerative therapies," stated Dr. Alan Tuchman, Chief Executive Officer.  

"Each of these distinguished leaders in AD research brings pioneering expertise in diverse scientific disciplines, including molecular mechanisms of neurodegeneration and regeneration, clinical trials of AD therapeutics, and interacting biochemical pathways of aging, synaptic loss, and neuronal loss," stated Dr. Daniel Alkon, President and Chief Scientific Officer.

Scientific Advisory Board members include:

Dr. George Perry, former Dean of the College of Sciences, Semmes Distinguished University Chair in Neurobiology, Professor of Biology and Chemistry at the University of Texas at San Antonio. Dr. Perry is recognized in the field of Alzheimer's disease research particularly for his work on oxidative stress. His research is primarily focused on the mechanisms and pathophysiological consequences of the cytopathology of Alzheimer disease.  Dr. Perry is the current and founding editor-in-chief for the Journal of Alzheimer's Disease, an international multidisciplinary journal that specializes in Alzheimer's disease.

Dr. Marwan Sabbagh, a leader in the field of Alzheimer's disease and related disorders, is professor of Neurology in the Alzheimer's and Memory Disorders Division at the Barrow Neurological Institute in Phoenix, Arizona. Previously, Dr. Sabbagh served as the Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. Dr. Sabbagh has published over 400 scientific and medical research articles on Alzheimer's disease and remains a prominent investigator and key opinion leader in nationally recognized Alzheimer's prevention and treatment trials.

Dr. Paul Coleman, several decades as a Full Professor at the University of Rochester School of Medicine during which time he was Director of the University of Rochester Medical Center Alzheimer's Disease Center and Director of an NIH Training Program in Neurobiology of Aging. In 2015, he moved his laboratory to the Neurodegenerative Disease Research Center at the Bio-design Institute, Arizona State University.  Dr. Coleman's work has focused on differentiating changes in the brain in Alzheimer's disease from changes related to normal, non-demented ageing.  Most recently, Dr. Coleman's work has expanded into the realm of epigenetics.  Dr. Coleman has received a number of awards for his work, including a Leadership and Excellence in Alzheimer's Disease Award from the National Institutes of Health (one of 12 ever awarded) and a Pioneer Award from the National Alzheimer's Association.

Professor Robert Howard, Professor of Old Age Psychiatry at University College London, and Mental Health Lead of the University College London Hospitals' Biomedical Research Centre.  He and his colleagues investigate ways in which mental health symptoms in older people can be treated most effectively and safely through development of new psychological therapy approaches, optimizing the use of existing medications and of novel and repurposed agents. Their trials have shown the cognitive, functional, and independent living benefits of continuing dementia drugs until the late stages of Alzheimer's disease.

Dr. Zaven Khachaturian is the President of the Campaign to Prevent Alzheimer Disease (PAD2020.org). He is the former Director, Office of Alzheimer's Disease at the National Institutes of Health (NIH), which was responsible for coordinating all Alzheimer's disease related activities NIH-wide. He also serves as the Associate Director, Neuroscience & Neuropsychology of Aging Program at the National Institution on Aging NIA / NIH. He is widely recognized as the Chief Architect of NIH-funded programs of research on brain aging and dementia-Alzheimer syndrome.

As a reminder, Synaptogenix will hold a corporate update conference call this afternoon for investors. The call will take place at 4:30pm ET and will be hosted by the Company's Chief Executive Officer, Dr. Alan Tuchman, and its President and Chief Scientific Officer, Dr. Daniel Alkon. Drs. Tuchman and Alkon will also take live Q&A following their prepared remarks. The U.S. toll free dial-in for the conference call is (877) 407-8293, and the international dial-in number is 1-(201) 689-8349.

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, 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. These forward-looking statements include statements regarding the anticipated initiation of a clinical trial to treat Multiple Sclerosis with Bryostatin and continued development of use of Bryostatin-1 for Alzheimer's disease, Fragile X 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

800-811-5591
ir@synaptogen.com

Robert Weinstein
Chief Financial Officer
Synaptogenix, Inc.
rweinstein@synaptogen.com

Cision View original content:https://www.prnewswire.com/news-releases/synaptogenix-announces-changes-to-scientific-advisory-board-in-preparation-for-phase-2-data-301593226.html

SOURCE Synaptogenix, Inc.

FAQ

What is the significance of the changes to the Scientific Advisory Board at Synaptogenix?

The changes enhance the company's capacity to develop therapies for Alzheimer's and other neurodegenerative diseases, leveraging the expertise of prominent researchers.

When will Synaptogenix announce the Phase 2 data for Bryostatin-1?

The Phase 2 data is expected to be announced later this year, following the current preparations.

What conditions is Bryostatin-1 being developed to treat?

Bryostatin-1 is being developed for advanced Alzheimer's disease and has also received Orphan Drug Designation for treating Fragile X syndrome.

Who are the key members of the newly formed Scientific Advisory Board?

Key members include Dr. George Perry, Dr. Marwan Sabbagh, Dr. Paul Coleman, Professor Robert Howard, and Dr. Zaven Khachaturian, all recognized for their expertise in neurodegenerative diseases.

How does the Orphan Drug Designation affect Bryostatin-1?

The Orphan Drug Designation provides Synaptogenix with certain benefits for the development of Bryostatin-1, including tax incentives and market exclusivity upon approval.

Synaptogenix, Inc.

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