Axsome Therapeutics Appoints World Leading Experts to Depression Scientific Advisory Board

NEW YORK, March 19, 2015 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the treatment of pain and other central nervous system (CNS) disorders, today announced the formation of its Depression Scientific Advisory Board ("Depression SAB") comprised of leading experts in the areas of depression, U.S. Food and Drug Administration (FDA) regulations, and clinical trial design. These experts will provide key scientific, clinical, and strategic guidance concerning Axsome's development programs in depression and other CNS disorders.

The following members have been appointed to Axsome's Depression SAB:

• Maurizio Fava, M.D., Director of the Clinical Research Program, Executive Vice Chair of the Department of Psychiatry, at Massachusetts General Hospital (MGH); Slater Family Professor of Psychiatry, at Harvard Medical School.  
• Thomas Laughren, M.D., Division Director (retired) for the Division of Psychiatry Products, at the U.S. Food and Drug Administration (FDA).  
• Dan Iosifescu, M.D., Director of the Mood and Anxiety Disorders Program, Associate Professor of Psychiatry and Neuroscience, at the Icahn School of Medicine at Mount Sinai; Consultant in Psychiatry at Massachusetts General Hospital (MGH).

"We are honored that Drs. Fava, Laughren, and Iosifescu have accepted our invitation to join Axsome's Depression Scientific Advisory Board," said Herriot Tabuteau, M.D., Axsome's Chief Executive Officer. "We welcome their unparalleled clinical, research and regulatory knowledge, and look forward to continuing to work with them as we advance our product candidates."

Axsome Depression Scientific Advisory Board Member Biographies:

Maurizio Fava, M.D.

Dr. Maurizio Fava is the Director of the Clinical Research Program, Executive Vice Chair of the Department of Psychiatry, and Executive Director of the Clinical Trials Network and Institute, at Massachusetts General Hospital (MGH); and the Slater Family Professor of Psychiatry at Harvard Medical School. Dr. Fava is a world leader in the field of depression. He has authored or co-authored more than 600 original articles published in medical journals with international circulation, edited eight books, and published more than 50 chapters and over 500 abstracts. Dr. Fava obtained his medical degree from the University of Padova School of Medicine and completed residency training in endocrinology at the same university. He then moved to the United States and completed residency training in psychiatry at the MGH. He founded and was Director of the hospital's Depression Clinical and Research Program from 1990 until 2014. In 2007, he also founded and is now the Executive Director of the MGH Psychiatry Clinical Trials Network and Institute (CTNI), the first academic CRO specialized in the coordination of multi-center clinical trials in psychiatry. Under Dr. Fava's direction, the Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work. Dr. Fava's prominence in the field is reflected in his role as the co-principal investigator of STAR*D, the largest research study ever conducted in the area of depression, and of the RAPID Network, the NIMH-funded series of studies of novel, rapidly-acting antidepressant therapies. Dr. Fava has received several awards during his career and is on the editorial board of five international medical journals.

Thomas P. Laughren, M.D.

Dr. Thomas Laughren was Division Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at FDA until 2012. As Division Director for the Division of Psychiatry Products, Dr. Laughren oversaw the review of all psychiatric drug development activities conducted under INDs (Investigational New Drug Applications) and the review of all NDAs (New Drug Applications) and supplements for new psychiatric drug claims. He has authored and co-authored numerous papers and book chapters on regulatory and methodological issues pertaining to the development of psychiatric drugs, and is a frequent speaker at professional meetings on these same topics. Prior to joining the FDA in September 1983, Dr. Laughren was affiliated with the VA Medical Center in Providence, Rhode Island, and was on the faculty of the Brown University Program in Medicine. He received his medical degree from the University of Wisconsin in Madison, Wisconsin, and also completed residency training in psychiatry at the University of Wisconsin. Dr. Laughren is board certified in general psychiatry. Dr. Laughren has received numerous awards for his regulatory accomplishments. He is currently a consultant in psychiatric drug development.

Dan V. Iosifescu, M.D.

Dr. Dan Iosifescu is the Director of the Mood and Anxiety Disorders Program and Associate Professor of Psychiatry and Neuroscience at the Icahn School of Medicine at Mount Sinai. Dr. Iosifescu's research is focused on novel pharmacological treatment modalities (such as ketamine and other glutamatergic drugs), and on biological markers of treatment outcome in mood disorders, using neuroimaging and neurophysiology techniques to investigate structural, biochemical, and functional brain abnormalities in mood disorders and their impact on clinical treatment. After receiving his M.D. from the Institute of Medicine and Pharmacy in Bucharest, Romania, Dr. Iosifescu completed his internship and psychiatry residency at Massachusetts General Hospital (MGH) and McLean Hospital, serving as chief resident in consultation-liaison psychiatry. His research training included a neuroimaging fellowship in the Neuroscience Laboratory at Harvard Medical School, a psychopharmacology fellowship in the MGH Mood and Anxiety Disorders Institute, and a fellowship in the Clinical Investigator Training Program at Harvard and MIT. In parallel Dr. Iosifescu received a Master of Medical Science degree from Harvard University. Until April 2010, he was Associate Professor of Psychiatry at Harvard Medical School and Director of Translational Neuroscience in the Depression Clinical and Research Program and Site Director of the Bipolar Trials Network, both at MGH. Dr. Iosifescu has authored more than 100 papers in peer-reviewed medical journals, 14 book chapters and more than 100 abstracts. He has received a series of prestigious awards: the NARSAD Young Investigator Award (which he received twice), the Kaplen Award and the Livingston Award from Harvard Medical School, the APA Young Investigator Award, the NCDEU New Investigator Award, and a NIMH K23 Career Development Award.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of pain and other CNS disorders. By focusing on this therapeutic area, Axsome is addressing growing markets where current treatment options are limited or inadequate. Axsome has a balanced portfolio of clinical development stage as well as research stage products. Axsome Therapeutics aims to become a fully integrated biopharmaceutical company that develops and commercializes differentiated products, which increase the armamentarium of caregivers and improve the lives of patients. While the focus of the company is on developing its internally derived product candidates, Axsome also evaluates potential in-licensing opportunities to supplement its current portfolio.

CONTACT: Axsome Contact:
         Mark Jacobson
         Senior Director of Operations
         Axsome Therapeutics, Inc.
         45 Rockefeller Plaza, 20th Floor
         New York, NY 10111
         Tel: 212-332-3243
         Email: [email protected]

Source: Axsome Therapeutics, Inc.

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