This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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

Phase I Data Evaluating Safety, Tolerability And Pharmacokinetics Of Multiple Weekly Doses Of Dalbavancin Presented At The 23rd Annual ECCMID Meeting

CHICAGO, April 29, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced data from a Phase 1 study of its lead product candidate, dalbavancin, under investigation for the treatment of susceptible gram positive bacterial infections including MRSA. The data, presented at the 23 rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), demonstrate that dalbavancin, when administered to healthy subjects as an IV infusion weekly for a total of up to 8 weeks, was well tolerated.

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Weekly Doses of Intravenous Dalbavancin in Healthy Subjects Authors: M. Dunne, C. Sprenger, S. Moriarty (Branford, US) Poster #: P910

Study conclusions: Dalbavancin was well-tolerated when administered IV as a loading dose of 1000 mg followed by 500 mg weekly for a total of up to 8 weeks. With a loading dose of 1000mg on Day 1, the 500 mg weekly dose achieves steady-state by Day 8 with no observable accumulation. This dosing regimen of dalbavancin should be considered for further study in clinical indications which require longer duration of therapy, such as osteomylelitis.

Further Study Details

This was a single center, open-label, multiple-dose, safety, tolerability, and PK study of increasing dosing durations. The total sample size for this study was 18 subjects, divided into 3 dosing cohorts of 6 subjects each. All subjects were asymptomatic, non-smoking adult volunteers between the ages of 18 and 55. All subjects received 1000 mg IV on Day 1. Cohort 1 received subsequent 500 mg IV doses on Days 8, 15 and 22; Cohorts 2 received additional 500 mg IV doses on Days 29 and 36; and Cohort 3 received additional 500 mg doses on Days 43 and 50. Drug was administered over 30 minutes. Standard safety parameters were monitored throughout the study.

For the dalbavancin 500 mg IV dose given on the last day of dosing, the AUC (µg·h/mL) was 10202.82, 12992.79 and 12173.30 and the C-max was 160.00, 187.00 and 179.67 in Cohorts I, II and III respectively. The calculated elimination curve reflected the beta (β) T-1/2 of Dalbavancin of 99 to 109 hours. Steady state was achieved by Day 9 with no observable accumulation. No serious AEs were reported over the course of this study. The most common treatment emergent AE reported was mild pain in the extremity, reported by 2 subjects, without evidence of thrombophlebitis. No subject withdrew or was discontinued from the study. No laboratory abnormality was attributed to Dalbavancin.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
SYM TRADE IT LAST %CHG

Markets

DOW 17,678.23 -40.31 -0.23%
S&P 500 2,056.15 -4.90 -0.24%
NASDAQ 4,863.3620 -13.1570 -0.27%

Partners Compare Online Brokers

Free Reports

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