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LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. today announced the completion of the third 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. This is the first Phase 3 trial to be conducted for the indication of endocarditis in almost 20 years.
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 review of data from more than 100 treated patients, the DMC has recommended continuation of the trial.
Patients with blood cultures positive for the presence of S. aureus are currently being enrolled at sites in the U.S. and certain Western European countries. The study has recently been expanded to include patients with left-sided endocarditis. Previously the protocol included patients with right-sided endocarditis and complicated or uncomplicated bacteremia. 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. Cubist continues to expect data from the trial to be available in the first half of 2005.
Cubicin is indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of certain Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cubicin, it should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to Cubicin.
Source: Cubist Pharmaceuticals, Inc.