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
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.