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Phase III Trial of Doripenem in Patients With Complicated Urinary Tract Infection Launched
ALAMEDA, Calif., Dec. 23 /PRNewswire/ -- Peninsula Pharmaceuticals, Inc., a privately-held biopharmaceutical company, announced today that patient enrollment has begun in a phase III trial of its lead product, doripenem (also known as S-4661), a broad-spectrum carbapenem antibiotic.
The multicenter, double-blind, randomized, phase III trial will evaluate the safety and efficacy of intravenous doripenem in patients with complicated lower urinary tract infections or pyelonephritis. Approximately 450 patients will be enrolled in more than 50 centers in the United States, Europe and South America. The primary endpoint of the study is microbiological response in the microbiologically evaluable population at the test of cure visit, which occurs five to nine days after the completion of therapy.
"We are pleased to be enrolling patients in our first phase III trial soon after completion of our phase II program with doripenem," said Matthew A. Wikler, M.D., FIDSA, Chief Medical Officer and Executive Vice President at Peninsula. "The increasing incidence of resistance of gram-negative bacteria to numerous antibiotics, including fluoroquinolones, requires new drugs to treat hospital-based infections. Doripenem may prove to be an important therapy for infections caused by such resistant bacteria." Shionogi & Co., Ltd., the inventor of doripenem, has filed a New Drug Application for doripenem in Japan with the Japanese Ministry of Health, Labor, and Welfare.
Doripenem is a new member of the carbapenem class of antibacterials. Discovered by Shionogi & Co. Ltd., doripenem has demonstrated in vitro activity against many Gram-positive and Gram-negative bacteria, including penicillin-resistant Streptococcus pneumoniae, extended spectrum beta-lactamase-producing strains (bacteria that produce enzymes which reduce the activity of beta-lactam antibiotics), Pseudomonas aeruginosa and Klebsiella pneumoniae. Peninsula believes that current in vitro and in vivo data support its clinical development as a therapeutic agent for a number of serious bacterial infections.
Source: Peninsula Pharmaceuticals, Inc.