Positive Study Results for Ceftaroline Phase III Clinical Study for the Treatment of Complicated Skin and Skin Structure Infections Presented at ICAAC / IDSA
November 10th, 2008
2008 NOV 10 -- Forest Laboratories, Inc. (NYSE:FRX) presented a detailed analysis of CANVAS I, a globally conducted, multi-center, Phase III clinical trial, at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy / Infectious Diseases Society of America 46th Annual Meeting (ICAAC / IDSA) in Washington, DC. The results of this 702 patient study demonstrated that ceftaroline monotherapy achieved its primary endpoint of non-inferiority versus the combination of vancomycin and aztreonam in the treatment of complicated skin and skin structure infections (cSSSI).(1)
Forest also presented eighteen abstracts on data from preclinical studies that demonstrate the activity of ceftaroline against methicillin-resistant Staphylococcus aureus (MRSA), multi-drug resistant Streptococcus pneumoniae (MDRSP) and many gram-negative pathogens in both in vitro and in vivo models of infection.
Results of the CANVAS I study presented on Sunday show that ceftaroline-treated patients had a clinical cure rate of 91.1% compared to a vancomycin-plus-aztreonam clinical cure rate of 93.3% at the test of cure (TOC) visit in the clinically evaluable population (CE). In the modified-intent-to-treat (MITT) population, ceftaroline-treated patients had a clinical cure rate of 86.6% compared to a vancomycin-plus-aztreonam clinical cure rate of 85.6%. The study was designed 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 demonstrate that ceftaroline, as monotherapy, is highly efficacious and well tolerated in treating cSSSIs. Ceftaroline demonstrated efficacy in a variety of monomicrobial and polymicrobial infections including those with challenging pathogens and drug-resistant phenotypes. The full results from this study demonstrate that ceftaroline's efficacy as monotherapy is similar to combination therapy with vancomycin and aztreonam.
"We're very pleased with the data presented which corroborate ceftaroline's potential use for the treatment of complicated skin infections, including those caused by MRSA - a common yet highly serious and growing problem faced by hospitalized patients today," Marco Taglietti, Chief Medical Officer of the Forest Research Institute, explained. "We are committed to investing in highly effective therapies, such as ceftaroline, to treat the growing number of multi-drug resistant infections. Along with this commitment, it is our intent to build a novel and robust antimicrobial franchise."
