Durata Therapeutics Presents Results from Skin Lesion Measurement Study at IDWeek 2012
Study Results Support Company's Planned NDA for Dalbavancin
SAN DIEGO--(BUSINESS WIRE)-- Durata Therapeutics (NAS: DRTX) today announced data from a multicenter, observational study related to the clinical development program of its lead product candidate, dalbavancin. The results demonstrate the reliability of the measurement tools deployed by Durata Therapeutics in its two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.
The data are being presented at the Novel Antimicrobial Agents session of IDWeek in San Diego. IDWeek is the first-ever combined meeting of four prestigious societies: the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
A Study to Assess Skin Lesion Measurement Techniques Related to Acute Bacterial Skin and Skin Structure Infections (Dunne, et al). Poster Number 1624.
The U.S. Food and Drug Administration (FDA) issued Draft Guidance in August 2010 that redefines the primary endpoint to be used in clinical trials to support an indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The endpoint requires documentation of both cessation of spread of any cellulitis (skin infection) associated with the infection, as well as resolution of fever. This study was designed to provide evidence of reproducibility of the measurements of the erythema (skin redness) associated with these lesions.
In this study, 42 patients meeting criteria for an ABSSSI were enrolled and 39 were evaluated. Overall, both the repeated (intra-) observer and between (inter-) observer ruler measurements showed almost perfect reliability with ICC's >0.9 for area, length and width. The percent differences in ruler measurements between different observers were slightly larger than between repeated measurements by the same individual (17.4% vs. 4.1%, respectively). Variability was higher in smaller lesions.
There was almost perfect intra-observer reliability (ICC>0.9) comparing the longest and shortest lesion measurements by ruler compared to measurements derived programmatically from a computer-assisted planimetry assessment of lesions taken from the transparency grid. Lesions measured by digital camera and transparency were 35% and 31% smaller than the ruler, respectively.
"Study investigators concluded that measurement of the erythema associated with an ABSSSI can be reliably performed using a ruler," said the study's lead author and Durata Chief Medical Officer Michael Dunne, M.D. "These results validate the technique we are using to measure the primary endpoint in our Phase 3 clinical trials. We intend to submit this information with the New Drug Application (NDA) for dalbavancin in the first half of 2013."
Durata will display data from this and another dalbavancin-related trial (Poster Number 1622) in San Diego Convention Center Halls F-H from Thursday, October 18 at 9:30 a.m. until Saturday, October 20 at 6:00 p.m. Dr. Dunne will be at the poster for discussion on Saturday, October 20, 12:30 - 2:00 p.m. PT.
For more information on the two studies presented at IDWeek 2012, visit www.duratatherapeutics.com/media-center/publications.
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient's hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is currently enrolling and dosing patients in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
Statements contained in this press release contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements about the technique we are using to measure the primary endpoint in our Phase 3 clinical trials and the related New Drug Application that we plan to file with the U.S. Food and Drug Administration. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the "Risk Factors" section of our most recent quarterly report on Form 10-Q, which is on file with the SEC and is also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
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