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VistaGen Therapeutics Receives FDA Clearance of IND for Phase 2 Clinical Study of AV-101 as a Potential Treatment of Dyskinesia in Parkinson's Disease Patients
Company also Receives a Notice of Allowance from the USPTO for a New AV-101 U.S. Patent for Treatment of Dyskinesia Induced by Levodopa Therapy SOUTH SAN
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"Company also Receives a Notice of Allowance from the USPTO for a New AV-101 U.S. Patent for Treatment of Dyskinesia Induced by Levodopa Therapy\n\n\nSOUTH SAN FRANCISCO, Calif., Jan. 30, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet medical need, today announced that its Investigational New Drug (IND) application for AV-101, the Company's oral NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist, as a potential treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy has been cleared by the U.S. Food and Drug Administration (FDA). The FDA's IND clearance permits VistaGen to proceed with Phase 2 clinical development of AV-101 in this indication. The Company also announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 16/003,816 related to therapeutic use of AV-101 for treatment of dyskinesia induced by the administration of levodopa. The patent, once issued, will be in effect until at least 2034. \n\n \n \n\n \n\"Current drug treatment options for levodopa-induced dyskinesia, or LID, may cause serious side effects, including hallucinations and sedation. In all clinical studies to date, AV-101 has not been associated with any psychotomimetic side effects or drug-related serious adverse events. With its exceptional safety profile, recently successful preclinical studies in the leading primate model for LID, and the successful Phase 1b NMDAR target engagement clinical study conducted by Baylor College of Medicine in healthy volunteer U.S. military Veterans, we are excited by AV-101's potential as a novel therapy for LID,\" said Shawn Singh, Chief Executive Officer of VistaGen. \"These are important milestones for our AV-101 program, both a key regulatory advance and expanded commercial protection for AV-101 in the U.S. market.\" \nAV-101 Preclinical Data in LIDIn November 2019, at the 7th International Conference on Parkinson's and Movement Disorders in London, Dr. Thérèse Di Paolo, Professor in the Faculty of Pharmacy at Laval University and among the world's leading researchers focused on Parkinson's disease and LID, presented preclinical data involving AV-101 ...