Cubist Pharmaceuticals, Inc. announced the completion of the second planned safety review of patients enrolled in Cubist's ongoing international Phase 3 clinical trial examining the safety and efficacy of Cubicin (daptomycin for injection) in the treatment of infective endocarditis and bacteremia caused by Staphylococcus aureus.
Due to the high mortality rate associated with endocarditis, blinded clinical data from patients enrolled in the study are provided to an independent data monitoring committee (DMC) at pre-determined intervals to identify any safety-related issues. Based upon this second review of the data, the DMC has recommended continuation of the trial.
Patients with blood cultures positive for the presence S. aureus are currently being enrolled at sites in the U.S. and certain Western European countries. In the study, patients receive either Cubicin at 6 mg/kg once daily or the current standards of care, vancomycin in patients with confirmed methicillin-resistant S. aureus (MRSA) infection or a semi-synthetic penicillin if susceptible S. aureus is confirmed. This is the first Phase 3 trial to be conducted for the indication of endocarditis in almost 20 years. Cubist continues to expect data from the trial to be available in the first half of 2005.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cubicin, Cubicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to Cubicin.