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Positive Study Results for Ceftaroline Phase III Clinical Study for the Treatment of Complicated Skin and Skin Structure Infections Presented at ICAAC / IDSA
Date:10/27/2008

signed to achieve a non-inferiority margin of 10% for ceftaroline versus the comparator regimen for the above endpoints. The most common infections included deep, extensive cellulitis and major abscesses. The percent of patients with diabetes and peripheral vascular disease in the ceftaroline arm was 17.7% and 13.4%, respectively.(1) 30% of patients with a confirmed pathogen had a MRSA infection.

The most common pathogens isolated were S. aureus (MSSA and MRSA), Streptococcus pyogenes, Streptococcus agalactiae, Enterococcus faecalis, E. coli and P. aeruginosa. A comprehensive microbiological investigation was completed and ceftaroline demonstrated activity against a broad range of gram-positive pathogens and gram-negative pathogens. Microbiological eradication rates for ceftaroline alone were similar to those of the combination of vancomycin plus aztreonam (91.8% vs. 92.5%). MRSA eradication rates were also similar in the microbiologically evaluable patients in the ceftaroline and combination arms (94.9% vs. 91.8%).

"These new data add to the growing scientific evidence that support ceftaroline as a potential novel treatment for cSSSIs, including those caused by MRSA," said G. Ralph Corey, MD, Director, Infectious Diseases, Duke Clinical Research Institute. "These results are important because we see a growing number of infections, including many with difficult-to-treat organisms. Clearly new options are needed to optimize our current treatment capabilities."

The results of CANVAS I also demonstrate that ceftaroline was well tolerated. The majority of adverse events reported were mild and judged to be not treatment related. The percentage of patients who experienced an adverse event was similar in both treatment groups. The most common adverse events observed in the ceftaroline vs. vancomycin-plus-aztreonam arms were nausea (5.7% vs. 4.6%), headache (5.1% vs. 3.7%) and pruritis (3.1% vs. 8.4%).(1)

The data presented from CANVAS I demonstr
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SOURCE Forest Laboratories, Inc.
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