CORTEX MOVES TOWARD LIFT OF CLINICAL HOLD ON CX717

Cortex Pharmaceuticals has completed the in-life phase of both the one-week acute primate study and the two-week acute rat toxicology studies with its ampakine compound CX717. The tissue samples are now being prepared for histopathology assessments. These studies were part of the toxicology assessments requested by the FDA and are essential for a decision to lift the clinical hold.

Furthermore, the original tissue slides from the 13-week primate study have been assessed and a written consensus report has been prepared. At present Cortex is on schedule for meeting its target date for submission of its complete response to the FDA by the beginning of September 2006. The agency has committed to a 30-day review of this data upon such a submission.