Cubist Pharmaceuticals, Inc. Closes Enrollment Early in CONSERV(TM)-1 and CONSERV-2 Ph. 2 Trials for CB-500,929 (Ecallantide), in Development as Therapy to Reduce Bleeding in On-Pump Cardiac Surgery

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LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the early closing of enrollment in its ecallantide Phase 2 program. Ecallantide, in development as therapy to reduce bleeding in on-pump cardiac surgery, is now known as CB-500,929. After a regularly scheduled review meeting, the Data Safety Monitoring Board (DSMB) contacted the company to recommend a temporary suspension in enrollment in one of the CB-500,929 trials, CONSERV-2. The CONSERV-2 trial is evaluating a high dose of CB-500,929 (~75 mg total administered dose, which is the highest of three doses administered in the CONSERV-1 dose ranging study) in higher-risk-of-bleed patients undergoing on- pump cardiac surgery. The DSMB had observed a statistical difference in mortality between the arms of the CONSERV-2 trial that it felt needed to be assessed before the trial could be resumed. While overall mortality was consistent with expected outcomes for the patient population in the CONSERV-2 trial, the data for patients treated to date shows more deaths in the CB-500,929 arm. Initial review shows mortality observed in the trial was due to a variety of causes typically expected in a high-risk-for-bleed population undergoing cardiac surgery. There was no such imbalance detected in the CONSERV-1 trial, also being monitored by the DSMB.

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