Countervail Corporation


Preclinical Toxicology Study Shows Excellent Results On Countervail’s Lead Antidote Candidate

A recent preclinical toxicology study of Countervail’s lead organophosphate antidote was completed by SRI (an independent contract research organization in Menlo Park, CA) with support funding provided by the NIH/NINDS CounterACT program.  The objectives of this study were to evaluate the potential toxic effects, identify target organs of toxicity, and to estimate the no observed adverse effect level (NOAEL), the maximum tolerated dose (MTD) and toxicokinetic parameters of galantamine after a single intramuscular (im) administration to adult male and female Sprague Dawley rats.  In accordance with FDA guidance on Body Surface Area (BSA) species to species dose conversion, these galantamine im doses in the rat translate to an estimated im Human Equivalent Dose (HED) in a 60 kg human at a NOAEL of 14.6 mg and a maximum tolerated dose of 58.3 mg.  These data support that a galantamine dose previously demonstrated in other studies to be efficacious for improved survival against a supra lethal exposure to nerve agents should be well tolerated in humans.