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VistaGen Therapeutics (OTC QB: VSTA) Completes P1

A P1 Safety Study of AV-101 for Chronic Neuropathic Pain

VSTA completed its final P1 safety study of AV-101, a novel orally available pro-drug candidate being developed for treatment of multiple conditions involving chronic neuropathic pain. The study results indicate that AV-101 is safe and well tolerated, with favorable bioavailability and pharmacokinetics.

With $8.8 M of funding from the NIH and regulatory support from Cato Research. Recent data from the NIH suggest that the same neural pathway modified by AV-101 may be useful for treating depression.

AV-101 P1 safety study was a randomized, double-blind, placebo-controlled, dose-escalation clinical trial conducted at the University of California, San Diego (UCSD). The study involved 3 cohorts of healthy volunteers, each receiving multiple daily treatments of one of 3 dose levels of orally administered AV-101 over a 14-day period. The primary objectives of the study were to evaluate the safety, tolerability and pharmacokinetics (NYSE:PK) of three different daily doses of AV-101 compared to placebo controls. A total of 46 healthy volunteers completed the study. The oral administration of AV-101 was safe and well tolerated by all subjects at all 3 dose levels tested. In addition, the PK of AV-101 was fully characterized across the range of 3 dose levels in the study. The data indicate that AV-101 had good bioavailability and a favorable PK profile.

The Bottom Line: The primary safety and tolerability endpoints of the P1 program were met. Let's see how the P2 study progresses for the treatment of pain. VSTA's AV-101 IND application covered clinical development for neuropathic pain. Aimed at neurological disease and disorders and depression markets, AV-101, also known as "L-4-chlorokynurenine"(4-Cl-KYN), is a novel, orally available pro-drug that is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), which regulates an important neurotransmitter in the brain called the N-methyl-D-aspartate (or NMDA) receptor. A synthetic analogue of kynurenic acid, a naturally occurring neural regulatory compound, 7-Cl-KYNA is a potent and selective blocker of the regulatory GlyB-site of the NMDA receptor.

VSTA closed at $0.79 on 1/22/13 with increasing volume of 13.5 K shares from the past days of 0. Look for VSTA to open up for the day!

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.