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VistaGen Therapeutics Advances New-Generation Antidepressant Approved by European Patent Office

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In a milestone for South San Francisco-based VistaGen Therapeutics, the European Patent Office (EPO) has issued a Notice of Intention to grant the company patents for its antidepressant prodrug, AV-101.

VistaGen Therapeutics Inc.'s (VTGN:NASDAQ) central nervous system (CNS) formula AV-101 orally treats a variety of neurogenerative disorders. AV-101 is currently working through the Phase 2 development stage of a National Institute of Mental Health clinical study for treating major depressive disorder (MDD).

"We are extremely pleased to receive the EPO's notice of intention to grant significant CNS-related patent claims for AV-101. This is another substantial step forward in our plan to secure a broad spectrum of intellectual property protection for AV-101 covering multiple CNS indications," stated Shawn Singh, chief executive officer of VistaGen.

In the United States, more than 11 million people are prescribed antidepressant drugs, including a variety of serotonin and norepinehrine reuptake inhibiter products. But not all antidepressant drugs are created equal; effectiveness depends upon how well an individual's brain chemistry interacts with how a drug targets certain receptors. When a particular product fails to provide relief, people switch to other drugs, searching for the best effect. However, it can take months for an antidepressant to demonstrate its healing power, and meanwhile, the patients continue to suffer symptoms of depression. Adjunctive therapy with atypical or off-label drugs that target the NMDA receptor, such as Abilify or Ketamine, can incrementally bridge the relief gap, but they exhibit serious side effects.

This is where AV-101 comes of age.

AV-101 is part of an emerging class of antidepressant drugs targeting the NMDA receptor that may be shown to relieve depressive symptoms in days, not months. VistaGen Therapeutics is following the methodological playbook of Alkermes Plc's (ALKS:NASDAQ) pivotal study of its k-opioid receptor antagonist, ALKS-5461. VistaGen Therapeutics is preparing to advance AV-101 into a 180-patient, U.S. multicenter, Phase 2 adjunctive treatment study. The focus is on MDD patients with an inadequate response to standard FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University is principal investigator.

VistaGen reports, "AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including chronic neuropathic pain, epilepsy, Parkinson's disease and Huntington's disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit."

VistaGen Therapeutics' focus goes beyond treating depression. The company's mission is "applying human pluripotent stem cell technology, internally and with collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells."

In December 2016, VistaGen exclusively sublicensed rights to certain proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease to BlueRock Therapeutics LP, a next-generation regenerative medicine company established by Bayer AG (BAYRY:OTCMKTS; BAYN:XETRA) and Versant Ventures.

Maxim Group is bullish on VistaGen Therapeutics, issuing a 12-month $4 target price on the stock.

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