SAN FRANCISCO, Sept. 29 /PRNewswire/ -- Ceftaroline, a next-generation, broad-spectrum injectable cephalosporin, was highly efficacious in the treatment of complicated skin and skin structure infections (cSSSI) compared to standard therapy, according to Phase 2 clinical trial results presented today by Cerexa Inc. at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
In a randomized, observer-blinded, multi-center trial of 100 patients with local and systemic signs of cSSSI, the clinical cure rate in the clinically evaluable population was 96.7% for patients treated with Ceftaroline and 88.9% for those treated with a gold-standard comparator regimen of vancomycin, with or without adjunctive aztreonam. The microbiological response rate in the microbiologically evaluable population was 95.2% for the Ceftaroline group and 85.7% for the standard therapy group. Ceftaroline also demonstrated excellent in vitro activity against gram-positive and gram-negative organisms isolated from patients in the study, including 100% of methicillin-resistant Staphylococcus aureus (MRSA) isolates inhibited at 0.5 mg/L or less.
"The results clearly validate Ceftaroline's potential as a breakthrough first-line therapy for the treatment of serious and increasingly resistant bacterial infections," said Dennis Podlesak, Chief Executive Officer of Cerexa. "With today's limited treatment options, we look forward to advancing Ceftaroline into Phase 3 trials before year-end."
At ICAAC, which runs through tomorrow, Cerexa is providing clinical and preclinical data in multiple presentations that show the activity, safety and efficacy of Ceftaroline.
In March 2006 the U.S. Food and Drug Administration granted Ceftaroline Fast Track designation for the treatment of cSSSI caused by MRSA. In granting this designation, the FDA noted that Ceftaroline has the potential to address an unmet medical need due to its ability to benefit patients who are unresponsive to existing therapies or who are unable to tolerate existing therapies due to serious toxicities that are present in such therapies.
"Ceftaroline was highly efficacious and very well tolerated in these ill patients," said Dr. George H. Talbot, Cerexa's Chief Medical Officer. "We are committed to developing Ceftaroline as rapidly as possible to provide patients and physicians with an important new treatment for complicated skin and other community- and hospital-acquired infections."
In the Phase 2 trial, the most common adverse event observed in the Ceftaroline group was mild headache. No drug-related serious adverse events were observed for Ceftaroline. In both the Phase 2 trial and earlier Phase 1 trials, Ceftaroline displayed a favorable adverse event profile consistent with the established safety profile of the cephalosporin class, with the vast majority of side effects being mild in nature. Adverse events typically associated with vancomycin were observed in the Phase 2 comparator group, including interstitial nephritis-related renal failure and "Red Man" syndrome.
About Ceftaroline
Ceftaroline acetate is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In preclinical studies and clinical trials to date, Ceftaroline demonstrated a favorable safety profile, similar to that of existing cephalosporins. Unlike marketed cephalosporins, Ceftaroline exhibits bactericidal activity against the most resistant strains of gram-positive bacteria, including MRSA. Ceftaroline has also demonstrated bactericidal activity against penicillin- resistant Streptococcus pneumoniae and common gram-negative bacteria. Cerexa licensed from Takeda Pharmaceutical Company Limited the exclusive right to develop and commercialize Ceftaroline in all countries worldwide except Japan.
About Cerexa
Cerexa Inc. is an innovation-driven biopharmaceutical company based in Alameda, Calif., that is focused on discovering, developing and commercializing a growing portfolio of novel anti-infective therapies for the treatment of serious, antibiotic-resistant infections. For more information, visit www.cerexa.com.
Contacts: Cerexa Inc. Stan Abel (510) 747-3911 seabel@cerexa.com David Schull Noonan Russo (858) 546-4810 david.schull@eurorscg.com
Cerexa Inc.CONTACT: Stan Abel of Cerexa Inc., +1-510-747-3911, seabel@cerexa.com; orDavid Schull of Noonan Russo, +1-858-546-4810, david.schull@eurorscg.com,for Cerexa Inc.
Web site: http://www.cerexa.com/
