VistaGen Therapeutics, Inc., a stem cell technology company focused on drug discovery and development, today announced the successful completion of its initial Phase 1 safety study of AV-101, the Company’s novel orally available prodrug candidate for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. Shawn K. Singh, JD, VistaGen’s Chief Executive Officer said, “This successful initial human safety study is an important first step towards our goal of developing AV-101 for several large market neurological diseases and disorders, including not only neuropathic pain but also epilepsy, Huntington’s disease and Parkinson’s disease. We are grateful for the substantial financial support we have received for our AV-101 program from the U.S. National Institutes of Health, as well as the world class regulatory and development assistance we have received from Cato Research Ltd. With that ongoing support and assistance, we now expect to complete our second AV-101 Phase 1 safety study during the first quarter of 2011.
About the Study
VistaGen’s initial AV-101 Phase 1 clinical trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and pharmacokinetics of single doses of AV-101 in two cohorts of healthy volunteers. AV-101 was well-tolerated by all subjects, had good bioavailability and did not cause any serious adverse events.
Aimed at the multi-billion dollar neurological disease and disorders market, AV-101, also known as “L-4-chlorokynurenine” and “4-Cl-KYN”, is a novel, orally available prodrug that is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-CI-KYNA), which regulates an important neurotransmitter in the brain called the N-methyl-D-aspartate (or NMDA) receptor. 7-CI-KYNA is a synthetic analogue of kynurenic acid, which is a naturally occurring neural regulatory compound and one of the most potent and selective blockers of the regulatory GlyB-site of the NMDA receptor.
VistaGen’s current AV-101 IND application covers clinical development for neuropathic pain. VistaGen expects its AV-101 Phase I clinical program for neuropathic pain to support the development of the drug candidate for neurological disorders, such as epilepsy, and neurodegenerative diseases, such as Huntington’s and Parkinson’s.