12:00 AM
Dec 07, 2009
 |  BioCentury  |  Product Development

Ecallantide Flip Side

A mere two days after Dyax Corp. received FDA approval for its ecallantide to treat hereditary angioedema, partner Cubist Pharmaceuticals Inc. had to stop enrollment in two Phase II trials of the molecule to reduce bleeding during on-pump cardiac surgery.

The news halved the price bump Dyax shares got from approval of Kalbitor ecallantide and cut by one-third the amount of data Cubist will get from the CONSERV-1 and -2 studies(see Ebb & Flow, A16). But Cubist still believes in the rationale for the compound in the surgery indication, and said that it will have enough data from the truncated trials to make a decision about what to do next.

Cubist decided to close enrollment early in both trials after a DSMB noted more deaths in the treatment arm of CONSERV-2. On a conference call, the company said eight deaths were observed in the ecallantide arm versus one death in the tranexamic acid...

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