Thursday, February 05, 2015 11:13:44 AM
VistaGen Therapeutics, a clinical-stage biopharmaceutical company developing innovative medicine for depression and conditions involving the central nervous system, has expanded its Clinical and Scientific Advisory Board with the addition of Gerard Sanacora PhD, MD, professor of psychiatry at the Yale School of Medicine and director of the Yale Depression Research Program.
“Dr. Sanacora and his colleagues at Yale Depression Research Program are among the global leaders in the discovery and elucidation of ketamine’s mechanism of action in depression,” Shawn Singh, CEO of VistaGen, stated in the news release. “His extensive research and recent clinical experience with the use of ketamine for treating [major depressive disorder] will be highly valuable as we advance AV-101 into late-stage development for depression and other [central nervous system] indications.”
Dr. Sanacora will focus on phase 2 and phase 3 clinical development of AV-101, VistaGen’s orally active NMDA receptor modulator for treating major depressive disorder (MDD). AV-101 is a unique prodrug candidate that produces, in the brain, 7-chlorokynurenic acid (7 Cl KYNA), one of the most potent and selective antagonists of the required glycine-binding site of the NMDA receptor, which results in down-regulation of NMDA signaling.
Previous MDD clinical studies of ketamine conducted by the NIH, Yale and others demonstrated rapid relief of depressive symptoms in treatment-resistant MDD patients, providing compelling clinical evidence of the key role of NMDA receptor modulators in a new MDD treatment paradigm. The studies also support AV-101’s potential as a novel rapid onset treatment for MDD.
“The relatively recent discovery of ketamine’s rapid onset antidepressant effects revolutionized our thinking about antidepressant medicine, ushering in development of a new generation of drug candidates with a fundamentally novel mechanism of action compared to the agents that form the mainstay of current depression treatment,” Dr. Sanacora stated. “VistaGen’s AV-101 is among the new generation of antidepressants that modulate the NMDA receptor and may act to normalize glutamate signaling to achieve the rapid and sustained antidepressant benefits of ketamine without ketamine’s significant negative side effects.”
In two randomized phase 1 safety studies funded by the National Institutes of Health (NIH), AV-101 was well tolerated without any serious adverse events or signs of sedation, hallucinations or the schizophrenia-like side effects often associated with ketamine.
VistaGen has signed a Letter of Intent with the National Institute of Mental Health (NIMH) to enter into a Cooperative Research and Development Agreement (CRADA) to collaborate with Dr. Carlos Zarate and his colleagues at the NIMH on an NIH-sponsored phase 2 clinical study of AV-101 in MDD. Under the proposed CRADA, Dr. Zarate, who serves as chief of the Section on the Neurobiology and Treatment of Mood Disorders and chief of the Experimental Therapeutics and Pathophysiology Branch at the NIMH, will be the principal investigator for the study.
For more information visit www.vistagen.com
Recent VTGN News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/23/2024 12:49:48 PM
- Vistagen Initiates PALISADE-4 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder • Business Wire • 09/23/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 09:00:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 09:00:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 09:00:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 09:00:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/28/2024 08:07:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 08:53:06 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 08:49:59 PM
- Vistagen Reports Fiscal Year 2025 First Quarter Financial Results and Corporate Update • Business Wire • 08/13/2024 08:21:00 PM
- Vistagen to Report Fiscal Year 2025 First Quarter Results and Host Corporate Update Conference Call on August 13, 2024 • Business Wire • 08/06/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/12/2024 08:27:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/10/2024 08:34:14 PM
- Vistagen Broadens PH80 Global Intellectual Property Portfolio with New Patents for the Treatment of Migraine • Business Wire • 07/09/2024 12:30:00 PM
- Vistagen Awarded Mental Health America’s Platinum Bell Seal for Workplace Mental Health for the Second Consecutive Year • Business Wire • 06/27/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/11/2024 08:27:53 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 06/11/2024 08:27:09 PM
- Vistagen Reports Fiscal Year 2024 Financial Results and Provides Corporate Update • Business Wire • 06/11/2024 08:20:00 PM
- U.S. Index Futures Fall Ahead of Federal Reserve Policy Meeting, Crude Oil Prices Decline • IH Market News • 06/11/2024 11:07:13 AM
- Vistagen to Report Fiscal Year 2024 Financial Results and Host Corporate Update Conference Call on June 11, 2024 • Business Wire • 06/07/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 08:10:11 PM
- Vistagen to Present at the Jefferies Global Healthcare Conference • Business Wire • 05/29/2024 12:30:00 PM
- Vistagen to Present at the 2024 American Society of Clinical Psychopharmacology (ASCP) Conference • Business Wire • 05/23/2024 12:30:00 PM
- Vistagen to Present at the 2024 RBC Capital Markets Global Healthcare Conference • Business Wire • 05/07/2024 12:30:00 PM
- Vistagen Announces Positive Results from Phase 2A Pilot Study of PH15 for Improvement of Psychomotor Impairment Caused by Mental Fatigue • Business Wire • 04/25/2024 12:30:00 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM