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news.Californian neuroscience company Cortex said that the clinical hold placed on its memory-enhancing drug CX717 in March this year by the US Food and Drug Administration has been lifted.
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The company plans to resume the clinical trials that were underway at the time the clinical hold was put into effect. The FDA put the trials on hold in March after raising concerns over some preclinical data in animals.
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.
Roger Stoll, CEO of Cortex, said: “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.”