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KING OF PRUSSIA, Pa. -- Vicuron Pharmaceuticals Inc. today announced the initiation of a Phase III clinical trial to evaluate the safety and efficacy of the company's semi-synthetic glycopeptide antibiotic, dalbavancin, vs. vancomycin, one of the current standards of care for the treatment of skin and soft tissue infections (SSTIs).
Two pivotal Phase III clinical trials of dalbavancin for the treatment of SSTIs are ongoing. This trial provides a comparator study versus one of the current standards of care. The company expects to complete all of these Phase III trials by the end of the first half of 2004 and to file a New Drug Application with the U.S. Food and Drug Administration (FDA) in the second half of 2004.
"In addition to planning the launch of our lead product candidate, anidlafungin, in the first half of next year, we continue to make steady progress on dalbavancin," said George F. Horner III, president and CEO of Vicuron. "Dalbavancin, which belongs to the same well established antibiotic class as vancomycin, presents notable market advantages, particularly once-weekly dosing. This dosing regimen allows for cost-effective administration, and a reduced need for intravenous lines that can prolong the risk of local and bloodstream infection which may translate into shorter hospital stays for some patients."
This Phase III randomized, controlled, multicenter open-label study is designed to evaluate the clinical efficacy of dalbavancin versus vancomycin for the treatment of adult patients with SSTIs suspected or confirmed to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Patients will be randomized to receive either two doses of intravenous dalbavancin the first dose on day one followed by a further dose on day eight or twice daily doses of intravenous vancomycin for 14 days.
The study will enroll up to 150 patients suffering from complicated or uncomplicated SSTIs with suspected or confirmed MRSA infection. The primary efficacy endpoint will be the assessment of clinical response at the time of follow-up visit.
"Treatment with vancomycin requires daily intravenous therapy and dose adjustments," said Timothy J. Henkel, MD, PhD, Vicuron's chief medical officer. "This is a non-inferiority study designed to demonstrate the efficacy and safety of dalbavancin vs. vancomycin and explore potential benefits of a once-weekly dosing regimen."
Source: Vicuron Pharmaceuticals Inc.