CHICAGO, April 24, 2014 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that it has initiated enrollment of a Phase 3b clinical trial to evaluate the efficacy and safety of its investigational product, Dalvance™ (dalbavancin) for injection, in a single 1500 milligram dose infused over 30 minutes in adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria.
"Our pharmacokinetic studies have indicated that there may be clinical efficacy in dosing Dalvance as a single 1500 mg infusion over 30 minutes to treat ABSSSI," said Michael Dunne, MD, Chief Medical Officer of Durata Therapeutics. "We are committed to advancing the care of patients with ABSSSI and potentially offering health care professionals an opportunity to choose the most appropriate dosing regimen based on patient and clinical needs."
Durata Therapeutics submitted a New Drug Application (NDA) in September 2013 seeking approval of Dalvance for the treatment of ABSSSI with a once-weekly dosage regimen of 1000 mg on Day 1 and 500 mg on Day 8, each administered over 30 minutes. The NDA was accepted for priority review by the FDA in November 2013 with an action date of May 26, 2014.
SINGLE DOSE STUDY DESIGN
The Phase 3b, multicenter, double-blind, randomized, controlled study compares a single dose of Dalvance with the once-weekly dosage regimen of Dalvance in adult patients with ABSSSI known or suspected to be caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Approximately 410 adult patients will be randomized to receive either one 1500 mg single dose of Dalvance on Day 1 or two doses of Dalvance with 1000 mg on Day 1 followed by 500 mg on Day 8. All doses will be administered over 30 minutes through a peripheral IV. For presumed Gram-negative pathogens, only IV aztreonam may be administered at randomization; for suspected anaerobic pathogens, oral or IV metronidazole may be used. Other antibiotics are prohibited. The primary outcome measure for efficacy evaluation will be the percentage of patients in each treatment group who demonstrate a clinical response at 48-72 hours after the initiation of therapy with study medication. The study was designed to meet the new standards required by regulatory authorities for antibiotic development in the United States.
ABOUT ABSSSI
For the six-month period of January to June 2010, a projected 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17 percent of the diagnostic category presentations were for skin and skin structure infections (SSSI). Of these presentations for SSSI, approximately 74 percent were disease types included in ABSSSI. This category of infection increased by 176 percent from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59 percent of these infections are estimated to be caused by MRSA in the U.S. Effective early treatment of ABSSSI is critical to prevent wound expansion and to avoid lengthy and costly hospital stays. Failure to successfully treat ABSSSI may result in hospital readmissions.
ABOUT DALVANCE
Dalvance is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. If approved, Dalvance would be the first drug for ABSSSI requiring only two once-weekly 30-minute intravenous doses (1000 mg on Day 1 and 500 mg on Day 8). Dalvance demonstrates bactericidal activity in vitro against a broad range of bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
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.
DALVANCE is a trademark of Durata Therapeutics Holding C.V.
FORWARD-LOOKING STATEMENTS
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 FDA's review and approval status of Dalvance and the potential impact of Dalvance's dosing schedule on patient care. 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 report on Form 10-K, 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.