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Patient Enrollment Completed for Phase 3 Trials of Dalbavancin for Skin, Soft Tissue Infections
"Vicuron completed enrollment in this comprehensive Phase III clinical development program for dalbavancin ahead of schedule," said George F. Horner III, President and Chief Executive Officer of Vicuron. "This important milestone achievement underscores our commitment to the therapeutic category and to demonstrating the benefits of our powerful and unique antibiotic, which we believe has significant advantages over currently available agents. With our first product candidate anidulafungin, a novel anti-fungal agent, awaiting a final FDA decision soon, and a regulatory filing expected for dalbavancin later this year, we are focused on becoming a leader in the hospital market."
Phase III Program Details
-- Complicated SSTIs: Randomized, controlled, double-blind study. Patients receive either intravenous dalbavancin or linezolid for 14 days. The primary endpoint is overall clinical and microbiological response at the conclusion of therapy.
-- Uncomplicated SSTIs: Randomized, controlled, double-blind study. Patients receive either intravenous dalbavancin or intravenous cefazolin, followed by oral cephalexin. The primary endpoint is overall clinical and microbiological response at the conclusion of therapy.
-- SSTIs caused by MRSA: Randomized, controlled, open-label study of patients with SSTIs suspected or confirmed to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Patients receive either two doses of intravenous dalbavancin one week apart or twice daily doses of intravenous vancomycin for 14 days. The primary endpoint is an assessment of clinical response at the time of follow-up visit.
Dalbavancin, a novel next-generation glycopeptide agent, belongs to the same class as vancomycin, the most widely-used and one of the few treatments available to patients infected with the most difficult-to- treat strains of Staphlococcus (Staph.): MRSA (methicillin-resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been specifically designed as an improved alternative to vancomycin. In vitro studies have shown that in addition to being potent against clinically important Gram-positive bacteria, it is bactericidal (i.e., kills bacteria rather than merely inhibiting their growth). The potency, tissue penetration and long half-life of dalbavancin may allow for more flexible and convenient dosing regimens than vancomycin. Dalbavancin may also help reduce the length of hospital stays by decreasing the need for intravenous lines that increase the risk of local and bloodstream infection. In preclinical and clinical studies to date, dalbavancin appears to be one of the most potent antibiotics in its class against MRSA and MRSE and has not shown significant dose-limiting side effects.
Source: Vicuron Pharmaceuticals Inc