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!

Cell Therapeutics' Upcoming FDA Worries

Stocks in this article: CTIC GENZ ALTH

SEATTLE ( TheStreet) -- Can Cell Therapeutics (CTIC) and its lymphoma drug pixantrone withstand the withering scrutiny of U.S. drug regulators?

The answer comes Feb. 10, when Cell Therapeutics travels to suburban Washington D.C. to make its case for pixantrone's approval to a panel of cancer experts convened by the U.S Food and Drug Administration.

The FDA's advisory panel will be reviewing data from a phase III study of pixantrone in patients with advanced, aggressive non-Hodgkin's lymphoma. The "EXTEND" study was conducted under a Special Protocol Assessment from the FDA, and the results, as presented by Cell Therapeutics to date, appear to be positive.

Of course, clinical data from "positive" phase III trials always looks great when pitched by the company developing the drug. The truth about a drug's efficacy is often something different and far less robust, especially after FDA reviewers finish picking apart the data line by line.

If the pixantrone data closet does have skeletons -- and let's face it, no drug skates through an FDA review unscathed -- here's where they might be found:

1. Missing patients?

Cell Therapeutics designed the pixantrone EXTEND study in 2003 - 2004 with the intention of enrolling 320 patients. In March 2008, however, Cell Therapeutics announced that it halted enrollment at 140 patients.

Will FDA accept the results from this study, given that only 40% of the planned patients actually enrolled? How does the drastically smaller number of patients effect the statistical powering of the study? And given the fact that the study is open label -- meaning doctors and patients know who's getting pixantrone and who's getting a comparator drug -- what amended rules were put in place to say that 140 patients were sufficient to prove pixantrone's efficacy?

1 of 5

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 17,815.80 +37.65 0.21%
S&P 500 2,066.60 +5.37 0.26%
NASDAQ 4,752.8210 +4.4250 0.09%

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