CHICAGO, May 13, 2014 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that data from two clinical trials of the company's lead product candidate, dalbavancin, was presented in six posters at the 24th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), which took place in Barcelona, Spain from May 10-13, 2014.
The following posters were presented:
May 10-13, 2014
Title: Treatment of acute bacterial skin and skin structure infection (ABSSSI) with dalbavancin in an outpatient setting Authors: M. Dunne, S. Puttagunta, M. Wilcox, H. Boucher, G.Talbot
Poster #: eP408
Conclusions: Outpatient treatment was almost exclusively performed in North America in this program. Those treated in the outpatient setting had substantial rates of fever, leukocytosis and SIRS criteria. Outcome rates at 48-72 hours, EOT and SFU were similar between dalbavancin and vancomycin/linezolid treated patients.
Title: Dalbavancin for the treatment of complicated skin and soft tissue infections in patients with and without diabetes mellitus in the DISCOVER studies Authors: M. Dunne, S. Puttagunta
Poster #: eP409
Conclusions: Assessment of diabetes based only on history would significantly underrepresent the actual incidence of diabetes mellitus in this population as elevated glucose, even in the setting of acute infection, may be a sign of underlying diabetes. The proportion of patients achieving > 20% reduction in lesion size at 48-72 hours and clinical success rates at the end of treatment and two weeks post treatment were lower in patients with a history of diabetes compared to non-diabetic patients. Comparable success rates were seen for patients treated with dalbavancin versus comparator antibiotics.
Saturday, May 10, 2014
Title: Are Staphylococcus aureus PVL toxin-positive isolates causing acute bacterial skin and skin structure infections (ABSSSI) associated with more severe presentation or worse outcome Authors: S. Puttagunta, H. Boucher, M. Wilcox, G.Talbot, M. Dunne
Poster #: P0193
Conclusions: PVL toxin-positive S. aureus isolated are not associated with greater areas of erythema at baseline in patients with ABSSSI. Patients with a PVL toxin-positive isolate had lower rates of fever than those with a PVL toxin-negative isolate but had a higher frequency of leukocytosis. Early clinical response rates were lower for patients with a PVL toxin-positive strain. However, similar proportions of patients in the two groups achieve ≥ 20% reduction in lesion size at 48-72 hours. Patients with an ABSSSI due to a PVL toxin-positive S. aureus may have slower resolution of fever than those with a PVL toxin-negative strain. Additional work is needed to understand the effect of PVL toxin production on the clinical presentation and outcomes of ABSSSI.
Tuesday, May 13, 2014
Title: Geographic differences in the presentation and outcomes of acute bacterial skin and skin structure infections (ABSSSI) in the DISCOVER program Authors: S. Puttagunta, G.Talbot, M. Wilcox, H. Boucher, M. Dunne
Poster #: P1818
Conclusions: Baseline demographic and many other important characteristics differed significantly between patients enrolled in North America and those enrolled in Europe/Asia. Nevertheless, early response rates and clinical success rates at EOT were comparable in both regions. Outcomes were similar for patients treated with either dalbavancin or the comparator.
Title: Clinical presentation and outcomes by subtype of infection in patients with acute bacterial skin and skin structure infections (ABSSSI) in the DISCOVER program Authors: S. Puttagunta, G.Talbot, M. Wilcox, H. Boucher, M. Dunne
Poster #: P1819
Conclusions: Patients with cellulits were older, had larger lesions and a slower reduction in lesion size relative to other infections. Major abscesses appear to respond to treatment most quickly. Dalbavancin treated patients had similar outcomes to comparator treated patients within each subtype of infection.
Title: Clinical presentation of acute bacterial skin and skin structure infections (ABSSSI) by baseline pathogen in the DISCOVER program Authors: S. Puttagunta, G.Talbot, M. Wilcox, H. Boucher, M. Dunne
Poster #: P1820
Conclusions: In the DISCOVER ABSSSI trials, a streptococcal etiology was more common in Europe/Asia than in North America, presumably due to more cellulitis in Europe. As compared with staphylococcal infection, streptococcal infection was associated with larger skin lesions; was more likely to be accompanied by leukocytosis, left shift, elevation of ASO/DNase titres; and had lower early response rates. Similar clinical success rates for the treatment of staphylococcal and streptococcal ABSSSI were seen with dalbavancin and comparators at 48-72 hours, end of treatment and short-term follow-up.
Copies of these posters are available on Durata's website: www.duratatx.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 new therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, Dalvance, under investigation for the treatment of patients with acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria. For more information about the company, visit www.duratatx.com.
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