DYAX ANNOUNCES POSITIVE INTERIM RESULTS FROM EDEMA2 TRIAL OF DX-88 IN HEREDITARY ANGIOEDEMA
Dyax has announced positive interim results from its Phase II, open-label, dose-ranging, repeat-dosing clinical trial of DX-88 in hereditary angioedema (HAE), referred to as EDEMA2 (Evaluating DX-88's Effects on Mitigating Angioedema).
The interim EDEMA2 results, based on 61 HAE attacks, highlight that DX-88 is well-tolerated and can elicit rapid clinical responses, with a median time to clinical response of 35 minutes.
In addition to the Phase II results, Dyax announced that it plans to initiate a Phase III trial of DX-88 in HAE, referred to as EDEMA3, during the first half of 2005. The company expects EDEMA3 to be a controlled, multicenter, international trial of approximately the same size as its successfully completed 48-patient EDEMA1 trial.
The DX-88 development program for HAE is in a joint venture with Genzyme. Pending a positive outcome of EDEMA3, Dyax expects to file a biologics license application during 2006 for marketing approval of DX-88 for the treatment of HAE in the U.S. The company also intends to file an equivalent marketing authorization application for approval of the drug in Europe.
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