FDA has lifted a clinical hold placed on Cortex Pharmaceutical's Ampakine compound CX717, in development for the treatment of Alzheimer's disease and attention deficit/hyperactivity disorder, the Irvine Calif. company reported Oct. 9.

The company may now resume clinical trials that were underway before the hold was put into effect, but Cortex did not release any additional information on when the studies will resume because it is awaiting receipt of a formal letter from FDA.

Cortex said it committed to an FDA-specified dose range for CX717 and will conduct further preclinical toxicological studies. Data from a three-month toxicology trial in animals will be available toward the end of the year.

"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 firm said.

In June, Cortex announced that FDA had accepted its proposed research plan for lifting the hold (¹ Also see "Cortex’ Plan For Clinical Hold Lift Approved By FDA" - Pink Sheet, 8 June, 2006.).

Cortex said that FDA had put the trials on hold in April based on animal study data.

The firm released positive findings from a Phase IIa study of CX717 in adult patients with ADHD in March. The company has also studied the compound in Phase IIa trials for Alzheimer's disease, memory cognition and wakefulness.

The company's proprietary class of drugs called Ampakine compounds increase the strength of signals at connections between brain cells, the loss of which could be responsible for memory and behavioral problems associated with Alzheimer's disease.

-Jessica Merrill (j.merrill@elsevier.com)

Cortex’ Clinical Hold On CX717 Lifted By FDA

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