Dalbavancin Study Results to be Presented in Three Posters at the 53rd Annual ICAAC Meeting
September 03 2013 - 3:03PM
Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that data
from two Phase 3 clinical trials of the company's lead product
candidate, dalbavancin, will be presented in two posters at the
53rd Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) in Denver, September 10-13, 2013. The trials
were conducted via a Special Protocol Assessment based on the FDA's
Draft Guidance for Developing Drugs for the Treatment of Acute
Bacterial Skin and Skin Structure Infections (ABSSSI). Dalbavancin
is under investigation for the treatment of ABSSSI caused by
susceptible Gram-positive microorganisms. These data will be used
to support the company's anticipated submission of a New Drug
Application to the U.S. Food and Drug Administration at the end of
September 2013.
In addition, R.M. Alden Research Lab will present in vitro data
regarding the activity of dalbavancin against isolates obtained
from osteomyelitis infections. This research was supported by a
grant from Durata Therapeutics.
The following posters will be presented:
Tuesday, September 10,
2013 |
12 p.m. - 2 p.m. |
Title: DISCOVER 1: A Randomized,
Double-blind Study of Dalbavancin (DAL) compared to Vancomycin (V)
(with an option to switch to Linezolid (L)) in Treatment of Acute
Bacterial Skin and Skin Structure Infections (ABSSSI) |
Authors: H. W. Boucher1, M. Wilcox2, G. H.
Talbot3, A. Das4, S. Puttagunta5, M. Dunne5 (1Tufts Med. Ctr.,
Boston, MA, 2Leeds Teaching Hosp., Leeds, UNITED
KINGDOM, 3Talbot Advisors, LLC, Anna Maria, FL, 4InClin,
San Mateo, CA, 5Durata Therapeutics, Branford, CT) |
Poster #: L-201 |
|
Tuesday, September 10,
2013 |
12 p.m. – 2 p.m. |
Title: DISCOVER 2: A Randomized,
Double-Blind Study of Dalbavancin (DAL) compared to Vancomycin (V)
(with an option to switch to Linezolid (L)) in Treatment of Acute
Bacterial Skin and Skin Structure Infections (ABSSSI) |
Authors: M. Wilcox1, H. W. Boucher2, G. H.
Talbot3, A. F. Das4, S. Puttagunta5, M. Dunne5 (1Leeds
Teaching Hosp., Leeds, UNITED KINGDOM, 2Tufts Med. Ctr.,
Boston, MA, 3Talbot Advisors, LLC, Anna Maria,
FL, 4InClin, San Mateo, CA, 5Durata Therapeutics,
Branford, CT) |
Poster #: L-202 |
|
Tuesday, September 10,
2013 |
12 p.m. – 2 p.m. |
Title: In Vitro Activity of
Dalbavancin Against Consecutive Isolates of Staphylococcus Species
Recovered from Osteomyelitis Infections |
Authors: D. M. Citron, E. J. Goldstein (R.M.
Alden Res. Lab., Culver City, CA) |
Poster #: E-140 |
The abstracts are currently available on the ICAAC website at
www.icaac.org and copies of the posters will be available following
the ICAAC meeting at www.duratatherapeutics.com.
About Dalbavancin
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, Inc.
Durata Therapeutics is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for
patients with infectious diseases and acute illnesses. Durata has
completed two global Phase 3 clinical trials with its lead product
candidate, dalbavancin, under investigation for the treatment of
patients with acute bacterial skin and skin structure infections
caused by susceptible gram-positive bacteria.
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CONTACT: Investor Relations and Public Affairs Contact
Allison Wey
Durata Therapeutics
Vice President, Investor Relations and Public Affairs
(312) 219-7017
awey@duratatherapeutics.com
Media Relations Contact
Geoff Curtis
DJE Science
(312) 233-1253
geoff.curtis@djescience.com
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