- Sanjay Mathew, M.D., expert in the psychopharmacological management of depressive and anxiety disorders, appointed as Board member -
- Thomas Laughren, M.D., expert in the safety and efficacy of psychiatric drugs with nearly 30 years of experience at the FDA, appointed as Board member -
- Maurizio Fava, M.D., existing member and world renowned expert in depressive disorders and psychopharmacology, appointed as Chairman -
VistaGen Therapeutics Inc. (OTCQB: VSTA) (VistaGen or the Company), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative product candidates for patients with diseases and disorders involving the central nervous system (CNS), today announced that it has appointed Sanjay Mathew, M.D. and Thomas Laughren M.D. to the Company's Clinical and Regulatory Advisory Board to join its existing members, Gerard Sanacora, M.D., Ph.D. and Maurizio Fava, M.D. The Company also announced today the appointment of Dr. Fava as Chairman of this Board.
"We are thrilled to have
attracted a number of the world's leading experts to VistaGen,
especially as we continue to explore the clinical benefits of AV-101 for
what we believe is potentially a transformative therapeutic advancement
for the treatment for individuals with major depressive disorder. These
key appointments occur as we prepare for the most important year ahead
for VistaGen, with numerous expected clinical and regulatory milestones
and key data readouts," commented Shawn Singh, Chief Executive Officer of the Company.
The Clinical and Regulatory Advisory Board
is working closely with VistaGen as it continues its ongoing
NIH-sponsored Phase 2a clinical study of AV-101, its lead oral prodrug
candidate for the treatment of major depressive disorder (MDD), which is
expected to report topline data in the first quarter of 2017, and as it
prepares to advance AV-101 into a Phase 2b MDD study in the fourth
quarter of this year.
"The standard antidepressants
and atypical antipsychotics that are available to treat depression
today are not effective in two out of three patients," commented Dr.
Fava. "This represents a tremendous unmet medical need for continued
research to find solutions for individuals and their families living
with depression. Given this climate of urgency, there is a great need to
advance clinical development programs in order to catalyze a paradigm
shift in therapeutic treatment options."
Dr. Fava is acknowledged as a
world renowned expert in depressive disorders and
psychopharmacology. He is currently Director of the Division of Clinical
Research of the Massachusetts General
Hospital (MGH) Research Institute, Executive Vice Chair, Department of
Psychiatry at MGH, and Executive Director of the MGH Clinical Trials
Network and Institute, as well as Slater Family Professor of Psychiatry
at Harvard Medical School. For more information on Dr. Fava, please click here.
Dr. Mathew is a leading
expert in the psychopharmacological management of adult patients with
difficult-to-treat depressive and anxiety disorders and is currently an
Associate Professor of Psychiatry and Behavioral Sciences at Baylor College of Medicine in Houston, Texas.
He is the Johnson Family Chair for Research in Psychiatry, Associate
Professor with Tenure in the Menninger Department of Psychiatry and
Behavioral Sciences, and director of the Mood & Anxiety Disorders
Research Program. For more information on Dr. Matthew, please click here.
Dr. Laughren is the former
Division Director for the Division of Psychiatry Products, Center for
Drug Evaluation and Research at the FDA. Prior to joining the FDA in
September, 1983, Dr. Laughren was affiliated with the VA Medical Center
in Providence and was on the faculty of the Brown University Program in Medicine. For more information on Dr. Laughren, please click here.
Dr. Sanacora is a Professor of Psychiatry at Yale University,
the Director of the Yale Depression Research Program, and the
Scientific Director of the Yale-New Haven Hospital Interventional
Psychiatry Service. Dr. Sanacora is recognized as a leading
translational neuroscientist in the area of mood disorders research. For
more information on Dr. Sanacora, please click here.
About AV-101 AV-101
(L-4-chlorokyurenine or 4-CI-KYN) is an orally-available prodrug
candidate, currently in Phase 2 development, initially for the
adjunctive treatment of MDD in patients with an inadequate response to
standard antidepressants. AV-101 has broad potential utility in other
diseases and disorders involving the CNS, including chronic neuropathic
pain and epilepsy and neurodegenerative diseases, such as Parkinson's
disease and Huntington's
disease. After crossing the blood-brain barrier and reaching brain
astrocytes, AV-101 is rapidly and enzymatically converted into
7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized, potent and
selective antagonist of N-methyl-D-aspartate (NMDA) receptors, acting by
blocking the glycine-binding co-agonist site of the NMDA receptor.
About VistaGen VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
dedicated to developing and commercializing innovative product
candidates for patients with diseases and disorders involving the CNS.
Our lead product candidate, AV-101, is a next generation, orally
available prodrug candidate in Phase 2 development, initially for the
adjunctive treatment of MDD in patients with an inadequate response to
standard antidepressants. AV-101 is currently being evaluated in an
ongoing Phase 2a clinical study being conducted by Principal
Investigator, Dr. Carlos Zarate,
Chief, Section on the Neurobiology and Treatment of Mood Disorders and
Chief of Experimental Therapeutics and Pathophysiology Branch at the
National Institute of Mental Health, and Clinical Professor of
Psychiatry and Behavioral Sciences, at The George Washington University and fully funded by the U.S. National Institutes of Mental Health.
For more information, please visit www.vistagen.com and connect with the Company on Twitter, LinkedIn and Facebook.
No comments:
Post a Comment