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Phase 3 Studies Initiated for Telavancin in Hospital Acquired Pneumonia

January 26, 2005 -- Theravance, Inc. announced today that it has enrolled the first patient in a Phase 3 clinical study (Assessment of Telavancin for Treatment of MRSA Pneumonia -- ATTAIN) of its investigational antibiotic, telavancin, in patients with hospital acquired pneumonia (HAP). ATTAIN is a multinational, multicenter, double-blind, active control study designed to assess the efficacy and safety of telavancin compared to vancomycin in the treatment of hospital acquired pneumonia caused by Gram-positive organisms such as Staphylococcus aureus and Streptococcus pneumoniae. Notably, the study is designed with co-primary clinical cure endpoints versus the vancomycin arm: the standard endpoint of non-inferiority overall and a superiority endpoint of clinical cure among those patients with methicillin-resistant S. aureus (MRSA) infections.

Telavancin, a rapidly bactericidal injectable antibiotic with multiple mechanisms of action, is a novel lipoglycopeptide that was discovered by Theravance through the application of multivalent drug design in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (including multi-drug resistant strains) and other Gram- positive pathogens. In addition to hospital acquired pneumonia, telavancin is currently in Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI).

Previously presented data have demonstrated that the bactericidal activity of telavancin against S. aureus is mediated by multiple mechanisms. This antibacterial activity results from interaction with D-Ala-D-Ala-containing peptidoglycan intermediates that leads, at submicromolar concentrations, to inhibition of the transglycosylation step of peptidoglycan synthesis during cell wall synthesis. Also, at higher, clinically-achievable concentrations, direct effects on bacterial membrane function, such as dissipation of membrane and increased permeability, are observed.

Source: Theravance, Inc.

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