VistaGen Therapeutics, Inc. (VSTA) Welcomes Dr. Ge
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Posted On: 02/05/2015 7:05:31 PM
VistaGen Therapeutics, Inc. (VSTA) Welcomes Dr. Gerard Sanacora to Clinical and Scientific Advisory Board
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
Please read full disclaimers at http://disclaimer.missionir.com
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
Please read full disclaimers at http://disclaimer.missionir.com
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