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Phase II Trial of Doripenem in Urinary Tract Infection Meets Primary Endpoints
In this Phase 2 trial, doripenem was well tolerated by patients, and met the primary endpoints of the trial in patients with complicated urinary tract infections. The Phase 2 trial, initiated earlier this year, investigated doripenem in hospitalized patients with complicated urinary tract infections, including pyelonephritis. Endpoints for this historically controlled study were microbiological efficacy, clinical efficacy and safety of the compound.
"Our experience with doripenem suggests that it may prove to be a useful antibiotic for the treatment of infections in hospitalized patients," commented Kurt G. Nabor, M.D., Professor of Medicine, Elisabeth Hospital in Germany. "There is a need for new antibiotics to treat the more difficult infections seen today; and based on the data to date, the profile of doripenem may meet this need."
"We anticipate that this data, in addition to our existing clinical data developed to date, will enable us to initiate multiple Phase 3 trials in the first half of 2004, with the ultimate goal of filing a new drug application for doripenem in North America," said Matthew A. Wikler, M.D., FIDSA, Chief Medical Officer and Executive Vice President at Peninsula. 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.
A total of 121 patients were enrolled in the study at 12 sites in Europe, South America, and the United States. Patients were randomized to receive three doses daily of either 250mg or 500mg of doripenem intravenously.
Doripenem is a new member of the carbapenem class of antibacterials. Discovered by Shionogi & Co. Ltd., doripenem has demonstrated potent 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), and P. aeruginosa. 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.