This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Durata Therapeutics Meets Primary Endpoints For EMA Review In Phase 3 Clinical Trial

Stocks in this article: DRTX

CHICAGO, Jan. 4, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced additional preliminary, top-line results for its DISCOVER 1 (" Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). As reported on December 11, 2012, preliminary top-line data show that dalbavancin achieved its primary endpoint of non-inferiority at 48-72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. The subpopulation of patients with MRSA at baseline achieved similar results. The secondary endpoint of clinical success at the end of treatment, the expected primary endpoint for regulatory review in Europe, was also met. Statistical analyses of the results from this secondary endpoint are included below in the updated table of top-line data.

Researchers were comparing two intravenous (IV) doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen had an option to switch to oral linezolid after three days of vancomycin treatment. The DISCOVER 1 protocol was conducted pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI. The protocol for the trial was also designed based on scientific advice provided by the European Medicines Agency (EMA). DISCOVER 1 was a randomized, double-blind, double-dummy trial conducted in 573 patients at 92 sites in the United States, Canada, and Europe comparing dalbavancin to a regimen of vancomycin and an option for oral linezolid for the treatment of ABSSSI.

Top-line Data from the DISCOVER 1 Trial
  Endpoint Dalbavancin Vancomycin/ linezolid Difference in point estimates (95% Confidence interval)
US Primary Endpoint Early response (48-72 hours) 240/288 (83.3%) 233/285 (81.8%) 1.5% (-4.6, 7.9)
  Patients with MRSA 37/44 (84.1%) 32/39 (82.1%)  
  Endpoint Dalbavancin Vancomycin/ linezolid Difference in point estimates (95% Confidence interval)
EMA Primary Endpoint Clinical Status (End of Treatment) 214/246 (87.0%) 222/243 (91.4%) -4.4% (-9.6, 1.6)*
  Patients with MRSA 30/35 (85.7%) 30/31 (96.8%)  
  Investigator Assessment (End of Treatment) 233/246 (94.7%) 237/243 (97.5%) -2.8% (-6.7, 0.7)
*adjusted for pre-specified baseline variables.  

Additional information regarding the trial can be found on clinicaltrials.gov.

"These data are consistent with our previous phase 3 study, VER001-9, which served as the pivotal study in our prior NDA submission and confirm the activity of dalbavancin in the treatment of patients with serious skin infections," said Dr. Michael Dunne, Chief Medical Officer.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,380.41 +263.17 1.63%
S&P 500 1,886.76 +24.00 1.29%
NASDAQ 4,258.4380 +41.0480 0.97%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs