Press Release Source: InterMune, Inc.
Intermune Completes Enrollment for Second Phase III Trial of Oritavancin For Bacterial Skin Infections
Thursday October 24, 8:04 am ET
Results Expected in First Quarter Next Year to Support NDA Filing By End of 2003
BRISBANE, Calif., Oct. 24 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that the company has completed patient enrollment in a second multi-center global Phase III randomized double-blind controlled trial of oritavancin for the treatment of complicated skin and skin structure infections (CSSIs). Oritavancin is InterMune's second-generation glycopeptide antibiotic to treat Gram-positive bacterial infections.
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This second Phase III study is testing the hypothesis that oritavancin has clinical efficacy at least equivalent to that of vancomycin/cephalexin in the treatment of patients with complicated Gram-positive bacterial skin infections. This trial will also evaluate the safety profile of oritavancin as compared to vancomycin and cephalexin.
Results are expected to be reported in the first quarter of next year. If favorable, they will be combined with previously reported positive Phase III results in this indication to form the basis of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by the end of next year.
Results of the first Phase III clinical trial were presented at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) last year and demonstrated that oritavancin cut treatment time in half for CSSIs versus current standard therapy of vancomycin plus cephalexin, with a similar adverse event profile.
"We look forward to confirming these findings in the second Phase III trial," said James Pennington, M.D., Executive Vice President of Medical and Scientific Affairs at InterMune. "This benefit could translate into reduced rates of non-compliance with oral therapy and subsequent relapse, thereby reducing health care costs associated with CSSIs. These advantages, combined with oritavancin's other positive characteristics, make it a strong candidate to become a new standard of care for serious Gram-positive infections, including strains resistant to many antibiotics."
This double-blind, active-control, multi-center study enrolled 1,252 patients with CSSIs with presumed or proven Gram-posy/y0e pathogens. Patients receive treatment with either 200 mg of oritavancin via intravenous infusion for 3-7 days followed by oral placebo, or twice-daily intravenous vancomycin for 3-7 days followed by oral cephalexin twice daily, for a total therapy course of 10-14 days.
"We are extremely pleased with the rapid progress we are making with oritavancin, which is another of our multiple ongoing development programs that address significant unmet medical needs and market opportunities," said Scott Harkonen, President and CEO of InterMune. "2003 will be the pivotal year for this program as we report results of this Phase III trial; complete the manufacturing scale-up for oritavancin; and file an NDA with the FDA."
About Oritavancin
Oritavancin, a second-generation glycopeptide antibiotic, is being developed by InterMune as a new treatment for Gram-positive infections. Oritavancin has the unique ability to kill harmful and resistant strains of Gram-positive bacteria, unlike many other agents that merely suppress them. Based on compelling clinical and preclinical data that suggest oritavancin could be effective in treating Gram-positive infections, InterMune is conducting numerous studies to prove efficacy and safety in these indications.
About InterMune
InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and cancer. For additional information about InterMune, please visit www.intermune.com.
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