Peninsula Pharmaceuticals, Inc. Begins Phase III Clinical Trial of Doripenem for the Treatment of Hospital-Acquired Pneumonia

Article

ALAMEDA, Calif. -- Peninsula Pharmaceuticals, Inc. announces that patient

enrollment has begun in the fifth pivotal phase III trial of its lead product

candidate, doripenem for injection, in patients with hospital-acquired

pneumonia. Doripenem, a broad-spectrum antibiotic, is a new member of the

carbapenem class of beta-lactam antibiotics.

This phase III trial will compare the safety and efficacy of doripenem for

injection with that of intravenous piperacillin/tazobactam in the treatment of

hospital-acquired pneumonia. In accordance with FDA guidelines, the primary

endpoint of the trial is clinical response at the test of cure visit (seven to

fourteen days following completion of therapy) in those patients who have been

enrolled in the study with a confirmed bacterial pathogen. Patients will be

enrolled in various countries around the world.

According to the U.S. Centers for Disease Control, hospital-acquired

pneumonia (HAP) is the second most common nosocomial infection in the United

States, accounting for approximately 15 percent of all hospital-associated

infections, and is associated with significant morbidity and mortality and

increased hospitalization costs. For patients with HAP, attributable

mortality rates of 20 percent to 33 percent have been reported. HAP can also prolong ICU

stays by an average of four to six days and hospitalization by four to nine days,

resulting in increased utilization of medical resources and healthcare costs.

The pathogens most frequently associated with HAP are gram-negative bacteria

such as Pseudomonas aeruginosa, and Staphylococcus aureus.

"We are pleased to be moving doripenem forward in another important

indication," said Matthew A. Wikler, MD, FIDSA, chief medical officer and

executive vice president at Peninsula. "We believe that doripenem will prove

to be a valuable antibiotic for the treatment of life-threatening infections

in hospitalized patients. We are encouraged by the data that has been

generated to date with doripenem and are committed to advancing it further for

numerous indications."

Doripenem has demonstrated in vitro activity against many aerobic and

anaerobic Gram-positive and Gram-negative bacteria, including

Enterobacteriaceae strains (including Escherichia coli and other extended

spectrum beta-lactamase-producing strains) and Pseudomonas aeruginosa.

Peninsula is also developing an inhaled version of doripenem to manage

pulmonary infections in cystic fibrosis patients.

Source: Peninsula Pharmaceuticals, Inc.

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