SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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.
“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,” said Shawn K. Singh, JD, VistaGen’s Chief Executive Officer. “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.
To date, the U.S. National Institutes of Health (NIH) has awarded VistaGen over $8.75 million for development of AV-101.
About VistaGen Therapeutics
VistaGen Therapeutics is a biotechnology company focused on using proprietary pluripotent stem cell technology to discover, rescue and develop novel drug candidates for a broad range of diseases and conditions. VistaGen’s integrated stem cell technology platform, Human Clinical Trials in a Test Tube™, is based on the differentiation of human pluripotent stem cells into multiple types of mature cells which can then be used in new generation assay systems for predictive toxicology, as well as drug discovery, rescue and development. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates long before they are ever tested in humans. VistaGen’s drug rescue activities are directed at creating new chemical variants of promising drug candidates that pharmaceutical companies have put on the shelf (discontinued in development) due to toxicity concerns, despite positive efficacy data demonstrating their potential therapeutic benefits. VistaGen’s goal is to develop a broad pipeline of drug rescue variants (proprietary new small molecule drug candidates) that will be as effective as the original drug candidates discontinued in development by others due to toxicity concerns but without the toxicity that caused them to be put on the shelf. VistaGen expects its pluripotent stem cell-based biological assays and screening systems to help discover, validate, prioritize, rescue and develop novel drug candidates with greater flexibility, speed and efficiency compared to traditional techniques currently used in the pharmaceutical industry.