Theravance, Inc. Announces Additional Results From Successful Phase 3 Telavancin Complicated Skin And Skin Structure Program

October 10, 2006 -- Theravance, Inc. today announced additional results from its ATLAS 1 and ATLAS 2 studies assessing the safety and efficacy of telavancin, a rapidly bactericidal injectable antibiotic with multiple mechanisms of action, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. The data will be presented today at the Third International Symposium on Resistant Gram-Positive Infections in Niagara-on-the-Lake, Ontario.

ATLAS 1 and ATLAS 2 were two large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies that enrolled and treated 1,867 patients in total, 719 of whom were infected with methicillin-resistant Staphylococcus aureus (MRSA).

In the combined ATLAS 1 and ATLAS 2 studies, patients with cSSSI were randomized (1:1) to receive either telavancin 10 mg/kg IV once daily or vancomycin 1 gm IV q 12hr (dosages adjusted per site specific guidelines) for 7-14 days. Evaluations of efficacy were performed at a follow-up visit that occurred 7-14 days following the end of treatment. Of the patients enrolled and treated, approximately 80% were clinically evaluable and approximately 70% were microbiologically evaluable. Mean age of the patients was approximately 49 years, 25% were diabetic, and 12% had moderate to severe renal insufficiency at baseline. Approximately 80% of the patients had a major abscess or deep, extensive cellulitis. Staphylococcus aureus was the most common baseline pathogen with the majority of the isolates being methicillin-resistant strains.

More about what Telavancin is: First what it treats: Cellulitis--> means that is an acute infection of the dermal layer of the skin.
The emergence and spread of bacterial resistance to vancomycin, an important antibiotic used to treat serious infections caused by gram-positive bacteria, has prompted active research to discover new glycopeptides and semisynthetic analogs with improved antimicrobial properties. Vancomycin and related glycopeptide antibiotics inhibit cell wall synthesis in susceptible bacteria by binding with high specificity to peptidoglycan precursors containing specific amino acids.

Telavancin, a semisynthetic derivative of vancomycin possessing an appended side chain that binds to specific areas of bacterial cell walls, is in late-stage clinical development for the treatment of serious gram-positive infections. Telavancin and other lipoglycopeptides exhibit superior in vitro activity compared to vancomycin including rapid, concentration-dependent bactericidal [killing]activity against glycopeptide-susceptible organisms as well as glycopeptide-intermediate susceptible Staphylococcus aureus and vancomycin-resistant S. aureus.

Theravance is traded on the NASDAQ (THRX) and is up 0.5% in afternoon trading to 28.65 in moderate trading. If this holds and the data continues to be positive, I will get in before the end of the year.