Cubist begins Phase 2 dosing of DX-88 in surgical use

By Mass High Tech staff

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FDA wants more data from Dyax over DX-88 [March 27, 2009]

Cubist Pharmaceuticals Inc. has started dosing in a 300-patient Phase 2 clinical trial for ecallantide, intended to cut down on blood loss associated with on-pump cardiothoracic surgery (CTS), the Lexington company announced.

Ecallantide, discovered by Cambridge-based Dyax Corp. and licensed by Cubist (Nasdaq: CBST), is a small protein that attracts and inhibits an enzyme, plasma kallikrein, associated with blood loss from on-pump CTS.

According to the Cubist website, Dyax discovered ecallantide (DX-88) with its phage display technology; in April 2008. Cubist then licensed the intravenous formula of ecallantide for surgical use.

In the meantime, the U.S. Food and Drug Administration is requesting more information from Dyax for the approval of DX-88.

Cubist researches and develops drugs to treat “unmet medical needs in the acute care environment,” a release by the company reports.

In addition to Cubist’s clinical trial, dubbed “Conserv-1,” the company is also conducting Phase 1 trials addressing Clostridium difficile-associated diarrhea (CDAD) and multi-drug resistant (MDR) Gram-negative infections.

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