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news.VistaGen Therapeutics has completed its initial Phase 1 safety study of AV-101, the company's novel orally available prodrug candidate for treatment of neuropathic pain.
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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.
The company claims that in the trial AV-101 was well-tolerated by all subjects, had good bioavailability and did not cause any serious adverse events.
VistaGen CEO Shawn Singh said that this successful initial human safety study is an important first step towards their 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 US National Institutes of Health, as well as the world class regulatory and development assistance we have received from Cato Research Ltd," Singh said.
"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."