ALAMEDA, Calif., April 5 /PRNewswire/ -- Cerexa, Inc. (http://www.cerexa.com) today announced the completion of patient enrollment for its multinational Phase 2 clinical trial of ceftaroline acetate (formerly PPI-0903) in patients with complicated skin and skin structure infections (cSSSI). Ceftaroline is a next generation, broad spectrum, cephalosporin antibiotic that combines the advantage of an enhanced gram-positive spectrum, including bactericidal activity against methicillin-resistant Staphylococcus aureus (MRSA), with broad gram-negative activity. The U.S. Food and Drug Administration recently granted ceftaroline Fast Track designation for the treatment of cSSSI caused by MRSA.
The Phase 2 trial enrolled 100 patients with cSSSI and was conducted at more than 20 study sites worldwide. The objective of this trial was to investigate the efficacy and safety of ceftaroline versus standard therapy. Cerexa initiated the Phase 2 trial in October 2005 and plans to release top- line data in the third quarter of 2006.
“Given the urgent and unmet need for new antibiotics and the Fast Track designation recently granted ceftaroline, we are pleased to have completed this trial ahead of plan,” stated Dennis Podlesak, Chief Executive Officer of Cerexa. “We are committed to developing ceftaroline as rapidly as possible for the benefit of patients suffering from serious and increasingly resistant infections. Due to its broad spectrum of coverage, including activity against resistant gram-positive pathogens, we believe ceftaroline has the potential to benefit patients and physicians by minimizing the need for combination therapy.”
Ceftaroline is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. Ceftaroline has demonstrated a favorable safety profile, based on preclinical studies and early clinical trials, similar to that of existing cephalosporins. Unlike marketed cephalosporins, ceftaroline has demonstrated in vitro bactericidal activity against the most resistant strains of gram-positive bacteria, including MRSA. Ceftaroline has also demonstrated in vitro bactericidal activity against penicillin-resistant Streptococcus pneumoniae and common gram-negative bacteria.
About Cerexa
Cerexa, Inc., located in Alameda, California, is an innovation driven, biopharmaceutical company committed to developing and commercializing a growing portfolio of novel anti-infective therapies for the treatment of serious and life-threatening infections. Cerexa’s lead compound, ceftaroline acetate, is a next-generation cephalosporin that is currently being investigated as a potential treatment for cSSSI. Cerexa licensed from Takeda Pharmaceutical Company Limited the exclusive right to develop and commercialize ceftaroline. For additional company information, please visit http://www.cerexa.com.
Contacts: Cerexa, Inc. Noonan Russo Stan Abel Jane Petrino (510) 747-3911 (212) 845-4274 seabel@cerexa.comjane.petrino@eurorscg.com
Cerexa, Inc.
CONTACT: Stan Abel of Cerexa, Inc., +1-510-747-3911, seabel@cerexa.com; orJane Petrino of Noonan Russo, +1-212-845-4274, jane.petrino@eurorscg.com,for Cerexa, Inc.
Web site: http://www.cerexa.com/
