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BRISBANE, Calif. -- InterMune, Inc. announces positive top-line results of a confirmatory pivotal Phase III clinical trial of the company's intravenous investigational antibiotic, oritavancin, for the treatment of complicated skin/skin-structure infections (cSSSI) caused by gram-positive bacteria.
This 1,267-patient trial achieved its primary efficacy endpoint and demonstrated that oritavancin was as effective as the comparator regimen of vancomycin followed by cephalexin, even when administered for approximately half the number of days. In addition, oritavancin was significantly better tolerated than the comparator regimen. The Company will submit these data for presentation at the next appropriate medical meeting.
"This is the second large clinical trial to demonstrate the excellent efficacy and safety profile of oritavancin," said James E. Pennington, MD, executive vice president of medical and scientific affairs at InterMune. "The evidence suggests a combination of superior tolerability and a reduction in the duration of treatment with this agent, which could represent a significant improvement over traditional therapy for patients with cSSSI."
Oritavancin is a second-generation glycopeptide antibiotic that has bactericidal activity against a broad spectrum of gram-positive bacteria, including those resistant to vancomycin.
The double-blind, active comparator, non-inferiority Phase III study was designed to assess the clinical and bacteriological efficacy of intravenous therapy with oritavancin alone versus the traditional approach of intravenous therapy with vancomycin followed by oral therapy with cephalexin. The study enrolled 1,267 patients with cSSSI caused by gram-positive pathogens at 103 sites in 22 countries. Patients were randomized to receive oritavancin once daily for three to seven days followed by oral placebo, or vancomycin for three to seven days followed by oral cephalexin, for a total course of 10 to14 days in both treatment arms. The primary efficacy endpoint of clinical cure of infection, as well as the secondary measure of bacteriological eradication, was met, demonstrating oritavancin was as effective as the comparator agents despite being administered for an average of only 5.3 days compared to 10.9 days for the vancomycin/cephalexin group.
Furthermore, oritavancin showed a significantly improved safety profile with a 19.2 percent relative reduction in the overall incidence of adverse events versus vancomycin/cephalexin (p<0.001).
"This is a positive and robust study that represents an important first step in positioning oritavancin to become a new standard of care and a significant advance for the more than two million patients with gram-positive infections treated with vancomycin each year," said Scott Harkonen, president and CEO of InterMune. "We are on track to file a New Drug Application in the first half of 2004 and to enter this rapidly growing market in 2005."
Deep soft tissue abscesses, wound infections and cellulitis are serious skin infections caused by a wide variety of bacterial pathogens. These infections require rapid and intensive antimicrobial intervention to minimize tissue damage and prevent further spread of infection. Each year, there are approximately 400,000 patients with cSSSI who require hospitalization in the United States. As drug resistance in hospitals and the community increases, the frequency of cSSSI that require hospitalization is likely to increase.
Oritavancin is a second-generation glycopeptide antibiotic that has demonstrated rapid bactericidal activity against a broad spectrum of gram- positive bacteria, including those resistant to vancomycin. Oritavancin has demonstrated safety and efficacy in the treatment of gram-positive infections in two Phase III clinical trials. Recently, InterMune reported results at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID) of in vitro studies that further demonstrate oritavancin's potent activity against isolates of susceptible and resistant strains of staphylococcus, streptococcus and enterococcus.
Oritavancin has not yet been approved by the FDA. In general, oritavancin has been well-tolerated in clinical trials. The most commonly observed side effects in this clinical trial were headache, nausea, vomiting, constipation and dizziness, which occurred at similar rates in the two treatment arms.
Source: InterMune, Inc.