FDA LIFTS CLINICAL HOLD ON CORTEX'S AMPAKINE

Cortex Pharmaceuticals announced it has received notification from the FDA that the clinical hold placed on its Ampakine CX717 in March has been lifted. The company may now resume the clinical trials that were under way at the time the clinical hold was put into effect. A formal letter from the FDA is expected to follow within 10 days.

The clinical hold was related to concerns over some preclinical animal data. In agreeing to the lifting of the hold, Cortex committed to an FDA-specified dose range for CX717. The company expects to have further toxicological information available toward the end of this year, after completion of three-month toxicology trials in both monkeys and rats. The company will then share those results with the FDA and mutually determine if the new information supports clinical investigations at higher dosage levels for CX717.

"The release from clinical hold is an important step for Cortex and the CX717 clinical program. It is fortunate that the company had the foresight to initiate the three-month toxicology trials early this summer, so that we can have further information from these studies available before year end 2006," Roger Stoll, CEO of Cortex, said.

The company's Ampakine drugs are being developed for a variety of neurological disorders, according to the company's website.