This Day On The Street
Continue to site
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

Gentium Encouraged By Late-stage Defibrotide Trial

The Associated Press

Italian biopharmaceutical company Gentium SpA said Wednesday results from a late-stage study of its drug Defibrotide failed to show a level of statistical significance required for proof of efficacy.

But the results did show "strong trends in favor of the Defibrotide-treated patients for complete response and survival," the company said in a statement.

The company is studying the drug as a treatment for veno-occlusive disease in stem-cell transplant patients, a common complication occurring soon after bone marrow transplants.

The study's primary endpoint was complete response at 100 days after a stem cell transplant, and its secondary endpoints included survival rate at 100 days and six months after stem-cell transplants.

Gentium Chief Financial Officer Gary Gemignani said in the statement the company expected that reaching "the required statistical threshold for a single trial would be difficult."

"We are pleased that the data are compelling and believe the results place us in a strong position to continue discussions with the FDA and others regarding next steps toward a regulatory filing," he said.

The study's clinical director, Dr. Paul Richardson, said in the statement he was encouraged by the results, "especially given the extremely sick patient population that was enrolled."

Gentium's shares were off 17 cents, or 5 percent, at $3.23 in early Nasdaq trading Wednesday.

Copyright 2009 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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
Only $9.95
14-Days Free
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
GENT $55.26 -0.88%
AAPL $130.28 0.00%
FB $81.53 0.00%
GOOG $565.06 0.00%
TSLA $218.42 0.00%

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs