AtheroGenics Nixes Max Dose in Diabetes Study
AtheroGenics (AGIX) has discontinued the highest dose of AGI-1067 in a planned dosing-range study for the diabetes treatment candidate.
The drugmaker, which announced the study change after Friday's market close, came to the decision to stop offering the 300-milligram dose after discussions with the Food and Drug Administration and review of the risk/benefit profile (namely abnormal liver function) in an earlier phase III trial.
Earlier this year the company
Though AGI-1067 was a no-go in heart disease, AtheroGenics said the 300-mg dose achieved significant results in diabetes endpoints and reduced the number of study subjects who developed diabetes for the first time. Based on those findings the company commenced the ANDES phase III trial to determine optimal dosing for glycemic control.But, after discussions with the FDA and a review of rare adverse effects on the liver with the 300-mg dose in the earlier ARISE trial, the company said it would discontinue the high dose. AtheroGenics said it's still continuing enrollment of the ANDES phase III trial with the 75-mg and 150-mg doses, expecting enrollment to be completed before the end of 2007, with the interim analysis planned for the second quarter of 2008. Shares of micro-cap AtheroGenics were down 28 cents, or 20%, at $1.12 in recent trading Monday.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV