Monday, November 17, 2014 9:49:56 AM
VistaGen signed a Letter of Intent to enter into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), to collaborate on a NIMH-sponsored Phase 2 clinical study of VistaGen’s lead drug candidate, AV-101, in Major Depressive Disorder. The disorder is one of the most common in the U.S.
Both VistaGen and NIMH look to complete the CRADA next month and both commencing and completing the Phase 2 depression study in 2015.
AV-101, an oral, non-sedating, non-hallucinogenic, NMDA receptor (NMDAR) glycineB-site antagonist, is a new generation of fast-acting, glutamatergic antidepressants with potential to treat millions of depression patients who are ineffectively served by classic antidepressants. Published NIH placebo-controlled clinical trials show evidence that ketamine, a classic NMDAR channel blocker, produces rapid-onset antidepressant effects. However, intravenously administered clinical utility of ketamine and other NMDAR channel blockers has been badly limited by their potential for abuse and dissociative side effects. By regulating as opposed to blocking NMDAR, AV-101 potentially can achieve the rapid-onset antidepressant effects of ketamine and other classic NMDAR channel blockers – all without causing their serious side effects.
Dr. Carlos Zarate, Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the NIH’s National Institute of Mental Health, is expected to be the Principal Investigator of the AV-101 Phase 2 depression study under the proposed Cooperative Research and Development Agreement.
VistaGen CEO, Shawn K. Singh noted, “Depression is a global public health concern, affecting over 350 million people worldwide, including millions in the U.S. We are pleased to be on a specific path headed toward extending our long-standing relationship with the NIH. Collaborating under the new CRADA will provide us and the NIMH with an important near term opportunity to make a major difference in the battle against depression.”
VistaGen is a clinical-stage biopharmaceutical company developing innovative medicine for depression, cancer and diseases and conditions involving the central nervous system. VistaGen’s lead drug candidate, AV-101, is a novel, potent, oral NMDAR glycineB-site antagonist entering Phase 2 clinical development focused on depression.
For additional information, visit the company’s website at www.vistagen.com
Recent VTGN News
- 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
- Vistagen to Present at the 2024 Anxiety and Depression Association (ADAA) Conference • Business Wire • 04/09/2024 12:30:00 PM
- Vistagen Initiates PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder Following Positive Results of PALISADE-2 • Business Wire • 04/01/2024 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