Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Versicor (VERS) -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (49)	5/12/2003 2:42:45 PM
From: tuck	Read Replies (2) \| Respond to of 83

Company says data is positive, but the stock dropped a bit after release of this PR (a few minutes after noon) on dalbavancin PII: >>GLASGOW, Scotland and KING OF PRUSSIA, Pa., May 12 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals (Nasdaq: MICU; Nuovo Mercato) today announced positive results from a Phase II trial of its lead antibiotic product candidate, dalbavancin, for skin and soft tissue infections (SSTIs) were presented in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). In the Phase II trial, the top-line results of which were previously reported, dalbavancin, a new semi-synthetic glycopeptide antibiotic, given once a week for two weeks, was shown to be effective in treating deep SSTIs and to be well tolerated. The once-weekly regimen produced higher clinical and microbiological response rates than a variety of standard care regimens. "Potential advantages of once-weekly dosing of intravenous dalbavancin compared with existing therapies are convenient administration, a reduced need for intravenous lines that can prolong the risk of local and bloodstream infection and resultant shorter hospital stays," said Timothy J. Henkel, M.D., Ph.D., chief medical officer of Vicuron and one of the co-authors of the oral presentation. "Studies of dalbavancin to date have shown that our antibiotic has potent in vivo and in vitro activity against key Gram-positive bacteria, excellent tissue penetration and a favorable side effect profile." Currently, once-weekly administration of dalbavancin is being studied in randomized, controlled, double-blinded Phase III clinical trials of complicated and uncomplicated SSTIs. Also underway is a Phase II study of dalbavancin for the treatment of patients with catheter-related bloodstream infections. Vicuron expects to complete Phase III trials in the first half of 2004 and to file a New Drug Application for dalbavancin with the U.S. Food and Drug Administration in the second half of 2004. "Dalbavancin is being developed as the first once-weekly injectable hospital-based antibiotic for serious Gram-positive infections, including the most resistant strains of Staph. No other marketed or investigational product offers this type of dosing convenience," said George F. Horner III, president and CEO of Vicuron. "The need for innovative antibiotics to treat serious and often deadly hospital-based bacterial infections is becoming more critical due to increasing rates of such infections and the rise in bacterial resistance, creating a large market opportunity for novel agents like dalbavancin." Details of Phase II Study A randomized, controlled study of the safety and efficacy of IV dalbavancin was conducted in 62 adult patients with complicated SSTIs. In the trial, the most common pathogen observed was Staphylococcus aureus (38% methicillin-resistant S. aureus; MRSA). Two experimental arms of the trial were compared: a single dose of 1100 mg of dalbavancin versus two doses of dalbavancin (1000 mg on day 1, followed by 500 mg on day 8). The control arm consisted of 7 to 21 days (mean = 15 days) of investigator-specified standard of care (comparator), which commonly involved treatment with one of the antibiotics, clindamycin, ceftriaxone, vancomycin, or cefazolin. Dalbavancin was well tolerated. No trends in laboratory abnormalities were observed in dalbavancin-treated patients. Adverse events were infrequent and similar in the three study arms. The primary and secondary efficacy endpoints were clinical and microbiological responses, respectively, at follow-up. Dosing of dalbavancin for two weeks resulted in numerically higher clinical (94.1% success) and microbiological (72.7% success) response rates of deep SSTIs than did either a single dose of dalbavancin (61.5% clinical success; 27.3% microbiological success) or comparator (76.2% clinical success; 64.3% microbiological success). No difference in outcomes for MRSA versus methicillin-sensitive S. aureus (MSSA) was seen. Also, favorable clinical biodistribution, pharmacokinetic, and dosing findings and results on preclinical microbiology studies with dalbavancin were presented by scientists in three poster sessions at ECCMID. Based on the results of in vitro studies discussed in one of the poster sessions, the development of staphylococcal mutations to dalbavancin occurred at a lower frequency than with other glycopeptide antibiotics. 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.<< snip Cheers, Tuck