[The clinical hold applies to DYAX’s DX-88 drug in hereditary angiodema, which is being developed as part of a joint venture with Genzyme. Toady’s action does not affect DYAX’s program in cystic fibrosis, which is partnered with Debiopharm of Switzerland.
This morning’s DYAX CC was one of the most unusual I’ve heard. The CEO disclosed that there were an unspecified number of rat deaths in a routine tox study, but he said the cause of death wasn’t known and may be unknowable. However, the likelihood that the deaths were drug-related would seem to be high because most of the deaths occurred at the highest rat dose tested.
No deaths or unusual toxicities have been encountered in any of the DX-88 human trials. Yet this kind of drug –an “engineered” or small protein, is no doubt among the riskiest classes of drugs; spikes in the in-vivo concentrations of such molecules can evidently cause unpredictable outcomes.]
>> Dyax Reports That Pending Further Preclinical Review DX-88 Placed on Clinical Hold
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 25, 2004--Dyax Corp. (Nasdaq:DYAX) reported today that the U.S. Food and Drug Administration (FDA) has advised the company that Investigational New Drug Applications (INDs) for its recombinant protein DX-88 have been placed on clinical hold until questions related to findings in preclinical animal studies have been answered to the FDA's satisfaction. This issue is expected to be resolved in the next several weeks and are not related to results from any human clinical trials.
DX-88 is in Phase II clinical development in a joint venture with Genzyme Corporation (Nasdaq:GENZ) for the treatment of hereditary angioedema (HAE). Topline results from EDEMA1, a recently completed 48-patient double-blind placebo controlled Phase II trial in HAE patients, are still expected to be announced in June. The only active DX-88 clinical trial affected by the hold is a repeat-administration extension study, referred to as EDEMA2. In this study, 12 HAE attacks have been treated to date, and three patients have been treated multiple times, with no reportable adverse events.
Independent of its joint venture with Genzyme, Dyax is also developing DX-88 for the treatment of patients undergoing on-pump coronary artery bypass grafting surgery (CABG). There are currently no active trials of DX-88 in the CABG indication. Positive Phase I/II results from a 42-patient trial in CABG were announced by Dyax in December 2003, and Dyax remains optimistic that its planned Phase II clinical studies in CABG will commence during the second half of 2004.
Dyax and Genzyme have submitted information to the FDA to assist in their review and expect to have further discussions with the FDA to address the agency's questions and concerns in the next several weeks.
Henry E. Blair, Chairman, President and CEO of Dyax commented, "We are committed to working with the FDA to resolve this issue as rapidly as possible so that we can continue with our DX-88 clinical development programs." <<
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