FREMONT, Calif., Dec. 17 /PRNewswire-FirstCall/ -- Versicor Inc. (Nasdaq: VERS - News) today announced the start of two Phase III clinical trials of its leading antibiotic product candidate, dalbavancin, for the treatment of skin and soft tissue infections (SSTIs). Dalbavancin is being developed as the first once-weekly injectable hospital-based antibiotic for Staphylococcal (Staph) and other serious Gram-positive infections. Each of the two randomized, double-blind studies will evaluate the efficacy and safety of dalbavancin versus current standard of care antibiotics.
"These clinical trials are designed to evaluate once-weekly dalbavancin compared to existing therapies for SSTIs," said Timothy J. Henkel, M.D., Ph.D., Versicor's executive vice president and chief medical officer. "Current therapies may require multiple doses daily over the treatment course and, in some cases, the continued presence of intravenous lines, which can create a prolonged infection risk. Once-weekly dosing with dalbavancin may reduce the need for IV lines in some patients, which could lead to fewer local and bloodstream infections and shorter hospital stays."
Versicor expects to complete these studies in the first half of 2004, and plans to file a New Drug Application for dalbavancin with the U.S. Food and Drug Administration in the second half of 2004. Previously reported Phase II clinical trial results in SSTIs showed that once-weekly dalbavancin produced higher clinical and microbiological response rates than a variety of standard care regimens, including vancomycin, and was also well tolerated. A Phase II study of dalbavancin for the treatment of patients with catheter-related bloodstream infections due to a Gram-positive organism is also underway.
"Dalbavancin's excellent in vitro activity against key Gram-positive pathogens and side effect profile to date, in addition to the potential for convenient once-weekly dosing, may give it a major competitive advantage for the treatment of these serious and increasingly prevalent infections," said George F. Horner, III, president and chief executive officer of Versicor. "We now have two Phase III clinical programs underway and, upon consummation of our merger with Biosearch Italia, we will have three Phase III products, putting us in a rare position in the industry with multiple near-term commercial opportunities."
Study Details
Each randomized, controlled, double-blind study will enroll approximately 550 hospitalized patients who will be examined for overall clinical and microbiological responses at the conclusion of therapy. In the first trial, patients with complicated skin and soft tissue infections (cSSTIs) will receive either a one gram intravenous dose of dalbavancin on study day one followed by a 500 mg dose on study day eight or approved doses of linezolid for 14 days.
In the second study, patients with uncomplicated skin and soft tissue infections (uSSTIs) will receive either a one gram intravenous dose of dalbavancin on study day one, with the option of adding a 500 mg dose on study day eight, or intravenous cefazolin, followed by oral cephalexin. On day eight, the investigator will decide the duration of study medication therapy (seven or 14 days) based on the clinical status of the patient.
About Dalbavancin
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 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 also bactericidal (i.e. kills bacteria rather than merely inhibiting their growth). The potency, tissue penetration, and long half-life of dalbavancin may allow more flexible and convenient dosing regimens than for vancomycin. In preclinical studies, dalbavancin appears to be one of the most potent antibiotics in its class against MRSA and MRSE. In phase I and II clinical studies to date, dalbavancin has been well-tolerated. Versicor is currently developing dalbavancin for commercialization in the United States and Canada under a licensing agreement with Biosearch Italia, which has rights for the compound for the rest of the world. Upon consummation of Versicor's merger with Biosearch Italia, the combined company will have worldwide rights for dalbavancin.... |
