Vistagen receives notice of allowance for AV-101 Canadian patent

Vistagen announced that the Canadian Intellectual Property Office (CIPO) issued a Notice of Allowance for a patent related to the use of AV-101 for reduction of dyskinesia (sudden uncontrolled movements) induced by the administration of levodopa (L-Dopa), the most commonly prescribed medication for treatment of Parkinson’s disease (PD). AV-101 is the Company’s oral prodrug antagonist at the NMDAR (N-methyl-D-aspartate receptor) glycine site. The patent, once granted, will not expire until at least 2034. The U.S. Patent and Trademark Office (USPTO) granted a related U.S. patent for Vistagen’s AV-101 and similar patents have been granted or are pending in several additional major pharmaceutical markets. Preclinical data previously published in the international, peer-reviewed journal, Cells, demonstrate the effects of AV-101 in a widely-used MPTP non-human primate model for reproducing motor complications of PD, including dyskinesia observed in many PD patients treated with L-Dopa. In this study, AV-101’s efficacy against L-Dopa induced dyskinesia (LID) was measured through behavioral scores on a dyskinesia scale, and a Parkinsonian disability scale was used to measure L-Dopa antiparkinsonian efficacy. The study demonstrated that AV-101 significantly (p = 0.01) reduced LID without affecting the timing, extent, or duration of the therapeutic benefits of L-Dopa. No adverse events attributable to the drug were observed during the study. The preclinical study was conducted by Dr. Therese Di Paolo, Emeritus Professor in the Faculty of Pharmacy at Laval University in Canada and among the world’s leading researchers focused on PD and LID, pursuant to Vistagen’s research agreement with CHU de Quebec – Universite Laval Research Center in Quebec, Canada.