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Press Release Source: Versicor Inc.
Versicor Announces Positive Phase 2 Study Results With Dalbavancin For Skin and Soft Tissue Infections
Company Plans to Begin Phase 3 Studies by End of 2002
Thursday September 5, 7:30 am ET
FREMONT, Calif., Sept. 5 /PRNewswire-FirstCall/ -- Versicor Inc. (Nasdaq: VERS - News) today announced positive Phase 2 clinical trial results with the Company's novel investigational antibiotic, dalbavancin, for the treatment of skin and soft tissue infections (SSTIs).
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The randomized, controlled study showed that dalbavancin given once a week for two weeks had higher clinical and microbiological response rates than a variety of standard care regimens, including vancomycin, given for a mean duration of 15 days for the treatment of SSTIs. As in all other clinical studies to date, dalbavancin was also shown to be very well tolerated. Dalbavancin is being developed as the first once-weekly injectable hospital-based antibiotic for Staphylococcal (Staph) and other serious Gram-positive hospital infections.
"This study was designed to demonstrate proof of concept of once-weekly dosing and help us select an optimum dose and duration for our Phase 3 trials in SSTIs," said Timothy J. Henkel, M.D., Ph.D., Versicor's executive vice president and chief medical officer. "We are very excited about these results that highlight the potential clinical benefits of once-weekly dalbavancin and give us confidence that this regimen warrants further evaluation in Phase 3 trials, which we plan to begin by the end of this year."
The trial enrolled 62 hospitalized patients with SSTIs involving deep skin structures or requiring surgical intervention, such as abscesses, infected ulcers, burns and cellulitis. Patients were treated with one of two dalbavancin-dosing regimens or a standard of care agent, which was specified by the investigator prior to randomization. Patients were examined for clinical and microbiological responses at the conclusion of therapy and two weeks following therapy. The primary endpoint was clinical response at follow up in evaluable patients. Adverse events and lab safety were also assessed. The most common pathogen was Staphylococcus aureus. The mean duration of treatment in the standard of care arm was 15 days. Outcomes in evaluable patients demonstrated a 94.1% clinical success rate (16/17 patients) with two doses of dalbavancin given one week apart (at day one and day 8), compared with 76.2% (16/21 patients) for the standard care arm (given daily for 7 - 21 days) and 61.5% (8/13 patients) for the single dose dalbavancin arm (given day one). Microbiological success was 72.7% (8/11 evaluable patients) with two weekly doses of dalbavancin compared with 64.3% (9/14 patients) for standard of care and 27.3% (3/11 patients) for the single dose dalbavancin arm.
Dalbavancin was well tolerated and adverse events were infrequent and similar across the study arms. There were no trends in any lab abnormalities in patients receiving dalbavancin.
"These results support a major competitive advantage for dalbavancin," said George F. Horner III, Versicor's president and chief executive officer. "Once-weekly dosing represents a significant clinical advance in the treatment of Gram-positive infections, because it may prevent the need for the continued presence of intravenous lines in some patients, which could mean fewer local infections and bloodstream infections with shorter hospital stays."
Dalbavancin is also being evaluated in a Phase 2 study for the treatment of bloodstream infections that are catheter-related. The Company plans to file a New Drug Application with the U.S. Food and Drug Administration in the second half of 2004.
According to the U.S. Centers for Disease Control and Prevention, nearly two million hospital-borne infections occur in the United States each year. Gram-positive bacteria, particularly Staph, are a significant cause of these infections.
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 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. Versicor is developing dalbavancin for commercialization in the United States and Canada under a licensing agreement with Biosearch Italia. Biosearch Italia is commercializing the compound in the rest of the world. |
