A live webcast of the presentation will be available by accessing the IR Calendar in the Investors section of VistaGen's website (www.vistagen.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.
AV-101 (4-CI-KYN) is an orally available CNS prodrug candidate, currently in Phase 2 development, initially for the adjunctive treatment of MDD in patients with an inadequate response to standard FDA-approved antidepressants. AV-101 also has broad potential utility in other CNS disorders, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases, such as Parkinson's disease and Huntington's disease.
AV-101's mechanism of action is fundamentally differentiated from all FDA-approved antidepressants, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. Unlike standard antidepressants which act on serotonin and related neurotransmitter pathways in the brain, AV-101 works through an entirely different mechanism, mobilizing glutamate pathways to enhance neuronal plasticity and improve the communication between neuronal cells. Dysfunction in these activities is increasingly recognized by scientists as an important contributor to depression and other serious CNS disorders.
AV-101 is currently being evaluated in a Phase 2a monotherapy study in MDD. This study is being fully funded by the U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH). The Principal Investigator of the study is Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH.
VistaGen is preparing to advance AV-101 into a 280-patient, U.S. multi-center, Phase 2b adjunctive treatment study in MDD in the first half of 2017, prior to the completion of the NIMH-sponsored AV-101 Phase 2a monotherapy study. The Principal Investigator of the Phase 2b adjunctive treatment study will be Dr. Maurizio Fava of Harvard University.
VistaGen Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation therapies for depression and other CNS disorders. VistaGen's lead CNS product candidate, AV-101, is a new generation, orally available prodrug in Phase 2 development, initially for the adjunctive treatment of MDD in patients with inadequate response to standard FDA-approved antidepressants. AV-101 is currently being evaluated in an NIMH-sponsored Phase 2a monotherapy study in MDD being conducted by Principal Investigator, Dr. Carlos Zarate Jr., of the NIMH. VistaGen is preparing to initiate an AV-101 Phase 2b adjunctive treatment study, in MDD patients with an inadequate response to standard FDA-approved antidepressants, in the first half of 2017.
For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the results of Phase 2a and Phase 2b clinical studies of AV-101 for treatment of MDD and other CNS diseases and disorders, protection of its intellectual property, and availability of substantial additional capital to support its operations, including the clinical development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
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SOURCE VistaGen Therapeutics, Inc.