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Phase I Data Evaluating Safety, Tolerability And Pharmacokinetics Of Multiple Weekly Doses Of Dalbavancin Presented At The 23rd Annual ECCMID Meeting

Stock quotes in this article: DRTX

CHICAGO, April 29, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced data from a Phase 1 study of its lead product candidate, dalbavancin, under investigation for the treatment of susceptible gram positive bacterial infections including MRSA. The data, presented at the 23 rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), demonstrate that dalbavancin, when administered to healthy subjects as an IV infusion weekly for a total of up to 8 weeks, was well tolerated.

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Weekly Doses of Intravenous Dalbavancin in Healthy Subjects Authors: M. Dunne, C. Sprenger, S. Moriarty (Branford, US) Poster #: P910

Study conclusions: Dalbavancin was well-tolerated when administered IV as a loading dose of 1000 mg followed by 500 mg weekly for a total of up to 8 weeks. With a loading dose of 1000mg on Day 1, the 500 mg weekly dose achieves steady-state by Day 8 with no observable accumulation. This dosing regimen of dalbavancin should be considered for further study in clinical indications which require longer duration of therapy, such as osteomylelitis.

Further Study Details

This was a single center, open-label, multiple-dose, safety, tolerability, and PK study of increasing dosing durations. The total sample size for this study was 18 subjects, divided into 3 dosing cohorts of 6 subjects each. All subjects were asymptomatic, non-smoking adult volunteers between the ages of 18 and 55. All subjects received 1000 mg IV on Day 1. Cohort 1 received subsequent 500 mg IV doses on Days 8, 15 and 22; Cohorts 2 received additional 500 mg IV doses on Days 29 and 36; and Cohort 3 received additional 500 mg doses on Days 43 and 50. Drug was administered over 30 minutes. Standard safety parameters were monitored throughout the study.

For the dalbavancin 500 mg IV dose given on the last day of dosing, the AUC (µg·h/mL) was 10202.82, 12992.79 and 12173.30 and the C-max was 160.00, 187.00 and 179.67 in Cohorts I, II and III respectively. The calculated elimination curve reflected the beta (β) T-1/2 of Dalbavancin of 99 to 109 hours. Steady state was achieved by Day 9 with no observable accumulation. No serious AEs were reported over the course of this study. The most common treatment emergent AE reported was mild pain in the extremity, reported by 2 subjects, without evidence of thrombophlebitis. No subject withdrew or was discontinued from the study. No laboratory abnormality was attributed to Dalbavancin.

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