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VSTA Embarking on Key Stage 2 Clinical Trial of Potential Breakthrough Major Depression Therapy
With the very public suicide of actor/comedian Robin Williams recently, the battle with major depressive disorder, or MDD, has moved even more into the public light. VistaGen Therapeutics, Inc. (OTCQB: VSTA) has become one of a small group of companies developing a new generation of antidepressant drugs to combat depression where current antidepressants and other therapies have come up short.
VistaGen is slated early in the New Year to begin a Phase 2 clinical trial of its AV-101 with the National Institute for Mental Health (NIMH), the mental health arm of the National Institutes of Health (NIH), builing on encouraging signs of safety and the drug’s potential to better combat major depression without the lag in onset of therapeutic benefits and some of the serious side effects often associated with currently-available anti-depression therapies and treatments.
With nearly $9 million of prior support from the NIH, VistaGen has been working diligently to develop AV-101 for various diseases and conditions of the central nervous system (CNS), including depression, chronic pain and other CNS disorders, and AV-101 is reportedly showing the notable potential for success in combating one of the most prominent disorders in the world – one which is estimated to affect about 1 in 20 people globally and indirectly impacts families and friends of those sufferers. That potential has now caught the attention of the NIMH, which is expected to collaborate with the company and sponsor its upcoming Phase 2 clinical study of AV0-101 in major depression.
In its NIH-funded Phase 1 clinical trials in healthy volunteers, AV-101 was safe, with no adverse side effects. In those studies, multiple subjects on AV-101 (none on placebo) expressed positive feelings of well-being similar to ketamine’s rapid-onset antidepressant effects, without any of ketamine’s serious side effects. There were no reports of hallucinations, sedation or any schizophrenia-like effects which have been reported with drugs such as ketamine and similar treatments that have produced what are called rapid-onset antidepressant results.
This Phase 2 trial is due to be both started and completed in 2015, offering hope for a potential safe and effective breakthrough treatment for major depression, something that has eluded patients and healthcare professionals for decades.
For more information, visit www.vistagen.com
