The FDA has determined that cardiovascular deaths andadverse reactions occurring among patients in Phase III trialsof ProCyte Corp.'s Iamin gel are not related to drug treatment.
The two trials included 339 diabetic patients who receivedeither placebo or one of two dosages of Iamin gel for treatmentof diabetic foot ulcer.
FDA's safety committee reviewed the Iamin trial data onThursday, within a week of asking ProCyte's to put a hold onthe trials. The agency requested that the trials be halted afterreceiving a report that seven patients had died fromcardiovascular events (CVs) and 21 others had other CVs (seeBioWorld, Dec. 14).
ProCyte immediately enlisted a biostatistician to analyze thebreakdown of the three treatment arms of the trials and foundthat the deaths and adverse reactions occurred in both theplacebo and drug regimens. The seven patients that died allhad pre-existing cardiovascular complications. That informationwas submitted to FDA on Monday.
ProCyte of Kirkland, Wash., said it plans to enrollapproximately 525 diabetics in the two concurrently runningPhase III studies. The company said it did not unblind thestudy data in determining the treatment assignments of thepatients who died or reported CVs, so the effectiveness of thedrug vs. placebo is still unknown.
Although ProCyte stock picked up $3.38 a share on Thursday toclose at $14.38, it was still down from last Friday's close of$15.50 a share. -- Brenda Sandburg
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