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Durata Therapeutics Presents New Pivotal Phase 3 Clinical Results And New In Vitro Data On Dalbavancin At ICAAC

DENVER, Sept. 10, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today presented clinical trial results from its two Phase 3 DISCOVER (" Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") 1 and 2 studies and new in vitro data of dalbavancin, further characterizing the effect of the investigational treatment against Gram-positive bacteria. In the two randomized, double-blind clinical studies, dalbavancin was shown to be non-inferior to the comparator regimen, vancomycin with an option to switch to oral linezolid, in treating acute bacterial skin and skin structure infections (ABSSSI). i, ii In both studies, dalbavancin met its primary and secondary endpoints. Further, recipients in the dalbavancin arms of the studies had fewer treatment emergent adverse events than those in the comparator arms. i, ii The in vitro data showed activity against Staphylococcus aureus strains, including methicillin-resistant strains (MRSA), recovered from patients with osteomyelitis-related wounds. iii The data were presented in three separate posters at the 53 rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, CO.

Dalbavancin is a novel antibacterial under investigation for the treatment of ABSSSI caused by susceptible Gram-positive microorganisms, such as Staphylococcus aureus (including MRSA and other multi-drug resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. Dalbavancin is bactericidal against Gram-positive bacteria and is administered with a once-weekly dosage regimen of 1000 mg on Day 1 and 500 mg on Day 8, over 30 minutes by intravenous infusion.

The specific infections in the DISCOVER 1 and 2 studies included cellulitis, major abscess and wound infection (approximately 50%, 30% and 20% across treatment groups, respectively). i, ii The median lesion size at baseline was >300 cm 2. i, ii In addition to local signs and symptoms of infection, patients were also required to have at least one systemic sign of disease at baseline, defined as temperature >38 C, white blood cell count >12,000 cells/mm 3 or ≥10% band forms on white blood cell differential (approximately 85%, 40% and 23% across treatment groups, respectively). i, ii Approximately 50% of patients met the criteria for Systemic Inflammatory Response Syndrome (SIRS). i, ii In DISCOVER 1, approximately 20% of patients were treated in the outpatient setting, i while in DISCOVER 2, approximately 27% were similarly treated. ii

"Dalbavancin appears to bring us results comparable to a standard regimen. This is especially impressive because the patients in these studies had more severe ABSSSI than seen in recent registrational studies, including very large skin lesions and high frequencies of fever and systemic inflammatory response syndrome (SIRS). With once-weekly dosing, this opens up the prospect of treating some patients outside of the most expensive clinical setting—the hospital," said Mark Wilcox, M.D., Head of Microbiology, Leeds Teaching Hospitals and Professor of Medical Microbiology at the University of Leeds, UK and an advisor to the DISCOVER program.

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