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| |  IDSA: Investigational Antibiotic, Cidecin (Daptomycin), Effective in Bacterial Skin/Soft Tissue Infections LEXINGTON, MA -- October 26, 2001 -- Cubist Pharmaceuticals, Inc. announced that it is presenting data today from its second pivotal Phase III clinical trial examining the safety and efficacy of its investigational antibiotic Cidecin® (daptomycin for injection) in the treatment of complicated skin and soft tissue infections (cSST) caused by Gram-positive bacteria. Two adequate, well-controlled trials are necessary to seek marketing approval for the cSST indication with the U.S. Food & Drug Administration (FDA). The data are being presented at the annual meeting of the Infectious Diseases Society of America (IDSA). In summary, the data showed that Cidecin achieved the required endpoint of statistical equivalence to the comparator agents based on criteria set forth in the protocol previously reviewed by the FDA. The comparator agents used are currently considered optimal antibiotic standards of care for these types of infections. The data revealed that in all study populations analyzed, the clinical success rates ranged from 65 percent to 75 percent in the Cidecin arm, versus 64 percent to 75 percent in the comparator arm (Table 1). Combining the data from Study 9801 with the data from the first Phase III cSST clinical trial (Study 9901; data presented in April 2001) revealed that the clinical success rates in the overall cSST program ranged from 74 percent to 85 percent in the Cidecin arm versus 73 percent to 84 percent in the comparator arm (Table 4). In Study 9801, clinically successful patients receiving Cidecin required fewer days of intravenous (IV) therapy than patients receiving the comparator agents by a two to one ratio, mirroring the results seen in Study 9901 (Table 2). As with Study 9901, the incidence of total adverse events in Study 9801 was similar in both arms of the trial. "These data presented today confirm what was seen in the first Cidecin Phase III trial," said Scott M. Rocklage, Ph.D., Chairman and Chief Executive Officer of Cubist, "and also form the basis for the first indication sought in our initial U.S. regulatory filing, anticipated to be completed in mid-2002. We are pleased that both Phase III cSST trials have reached the mandated statistical equivalence in clinical success rates, and also that fewer days of IV therapy were required using Cidecin in both studies. We are looking forward to announcing clinical results from our first Phase III Cidecin pivotal trial in the treatment of patients with hospitalized community-acquired pneumonia in the first quarter of 2002." Study 9801 enrolled patients predominantly in the U.S. and was a multi-center, randomized, double blinded (evaluator-blinded) study. The study enrolled 517 patients, aged 18-85 years, with complicated skin and soft tissue infections (cSST) caused by Gram-positive bacteria. "Complicated" infections are those requiring hospitalization and parenteral (intravenous) antimicrobial therapy. Infections included major abscesses, wound infections and infected skin ulcers. Patients were scheduled to be treated for seven to 14 days and randomized to Cidecin, 4 mg/kg once daily, or to comparator, where investigators had the choice of vancomycin, given twice daily, or a semi-synthetic penicillin (usually oxacillin) given four times daily. Patient outcomes were determined using the following criteria: * Clinical Success: evaluator-blinded assessment of clinical resolution or improvement with no further antibiotic therapy required. * Clinical Failure: evaluator-blinded assessment of worsening or inadequately improving clinical condition during therapy, up to and including one week post-treatment. Study populations were described as follows: * Intent-to-Treat (ITT): patients received at least one dose of study medication. * Modified Intent-to-Treat (MITT): Gram-positive pathogen at baseline culture * Clinically Evaluable (CE): patients fulfilled all protocol criteria (inclusion/exclusion criteria, duration of therapy & evaluations). * Microbiologically Evaluable (ME): clinically evaluable with Gram-positive pathogen(s) While the designs of clinical studies 9801 and 9901 were identical, patients in Study 9801 generally had more debilitating underlying disease than those in Study 9901, with a greater number of diabetic patients in the population and more patients with diabetic foot ulcers, with peripheral vascular disease and with infections caused by Methicillin-resistant Staphylococcus aureus (MRSA). SOURCE: Cubist Pharmaceuticals, Inc.
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