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Dyax DX-88 INDs on hold

May 25, 2004 7:00 AM UTC

The FDA placed on clinical hold the Phase II EDEMA2 trial of DYAX's DX-88 recombinant kallikrein inhibitor protein to treat hereditary angioedema (HAE), pending additional information related to preclinical studies. DYAX said the hold is related to sporadic deaths of rats in a toxicology study. However, the company said pathology reports showed the deaths did not appear to be related to the compound. DYAX CEO Henry Blair said rats in the study received 12 times the highest dose given to patients in clinical trials and 36 times the dose of DX-88 given in EDEMA2. Blair also said rats were given a one-minute bolus infusion, whereas patients are receiving 10-minute infusions. EDEMA2 is a repeat-administration extension study, in which 12 HAE attacks have been treated to date, with three patients having been treated multiple times. DYAX said it has provided FDA with related safety data and expects the issue to be resolved the next several weeks. ...