This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Gentium Announces Completion Of Preclinical And Clinical Studies For Defibrotide

VILLA GUARDIA, Italy, Feb. 8, 2011 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that ongoing preclinical and clinical studies on Defibrotide have been completed and confirmed its plan to file for regulatory approval of Defibrotide with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) by the end of the second quarter of 2011.

In the preclinical studies conducted, Defibrotide showed no inhibitory effects in human liver microsomes, indicating that Defibrotide is expected to have a low potential for drug-drug interaction.

In a reproductive toxicity study in rats and rabbits, Defibrotide given by 2-hour infusion showed maternal toxicity with effects on pregnancy and intrauterine development of the progeny, while effects on embryofetal development could not be determined. Defibrotide is being developed for the prevention and treatment of Veno-Occlusive Disease (VOD) in stem cell transplant recipients. Given the disease status and pre-transplant and chemo-inductive therapy regimens, pregnant females are unlikely to be included in the Defibrotide population.

A hERG tail current study with Defibrotide showed no inhibition of the hERG channel at any of the doses tested.

In line with these findings, a thorough ECG study demonstrated that Defibrotide did not prolong QT/QTc interval in healthy human volunteers at either the therapeutic dose (6.25 mg/kg) or at the supra-therapeutic dose (15 mg/kg), and showed no effects on other ECG parameters. The expected effect on the QT/QTc interval was observed with moxifloxacin as a positive control.

Also in line with previous studies, plasma pharmacokinetics in these healthy volunteers typically showed that Defibrotide had short half-life dose-dependent increase in Cmax and AUC and dose-independent clearance.

"No serious adverse events were reported in any of the 52 healthy subjects enrolled in our studies," said Dr. Massimo Iacobelli, Scientific Director of Gentium S.p.A. "A total of 30 mild adverse events were reported in 13 subjects: 5 in the Defibrotide therapeutic dose arm, 3 in the Defibrotide supra-therapeutic dose arm, 9 in the placebo arm, and 13 in the moxifloxacin arm. These results indicate that both the therapeutic dose and supra-therapeutic dose of Defibrotide were well tolerated in healthy volunteers."

1 of 2

Select the service that is right for you!

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 17,778.15 +421.28 2.43%
S&P 500 2,061.23 +48.34 2.40%
NASDAQ 4,748.3960 +104.0840 2.24%

Brokerage Partners

Rates from

  • 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