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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Deaths Mar Trial of Celgene Drug

Updated from 11:24 a.m. EST

Nearly a dozen patient deaths have been recorded in an ongoing clinical trial of Celgene's (CELG) experimental drug Revlimid, TheStreet.com has learned. If confirmed and attributable to the drug, the deaths could delay, or derail, Revlimid's chances for U.S. approval, which would force investors and analysts to reduce forecasts for the company's near-term earnings and sales growth.

Dr. Alan List of the H. Lee Moffitt Cancer Center in Tampa, Fla., and the lead investigator in Celgene's Revlimid MDS study, confirmed there were patient deaths. But he would not disclose a precise number because he is bound to a Celgene confidentiality agreement. List is a paid consultant to Celgene.

"There were some deaths in the study but very few were treatment related," says List. "Remember, we have a patient enrolled in this study who is 96, and the median age of patients is in the 70s, so the expectation for survival for one year is not high." The clinical trial in which the deaths occurred is testing Revlimid as a treatment for patients with a low-grade, low-risk form of myelodysplastic syndrome, or MDS, a cancer-like bone marrow disease.

Celgene shares fell on the news. They were recently down $1.67, or 5.7%, to $27.69 on eight times normal volume. The stock hit a three-year high of $32.58 on Nov. 11, adjusted for a 2-for-1 stock split in October.

There are 148 patients enrolled in the Revlimid study, which would put the death rate at just over 7% if the reports of 11 deaths are accurate.

Celgene's chief spokesman Brian Gill, asked to confirm or deny the patient deaths in the Revlimid study, said, "I, Brian Gill, am not aware of any deaths. I'm not saying there are or aren't any deaths." Gill declined to offer a formal Celgene response.

Gill added that a data safety monitoring board is charged with overseeing the safety of this Revlimid study in MDS patients. All serious adverse events, including patient deaths, in the study are supposed to be reported to the safety board, which is then charged with determining whether or not these adverse events are related to Revlimid.

"If the data safety monitoring board finds a correlation between deaths and the drug, then the study would be stopped," said Gill, adding that none of the ongoing Revlimid studies have been stopped.

But List acknowledged that the data safety monitoring board is being run by Celgene and several investigators involved in the study, including himself. There is no external, independent body making a determination of Revlimid's safety in the MDS study, which is not atypical for a phase II study.

Celgene has told investors that it expects to use data from this phase II study to seek marketing approval for Revlimid from the Food and Drug Administration during the first quarter of 2005. But this plan could be in jeopardy because 11 patients in this low-grade MDS study, all of whom took Revlimid, have died, according to a fund manager who learned of the deaths after speaking with a clinical investigator participating in the study. (The fund manager, who requested anonymity, has a short position in Celgene.)

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
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!

Markets

DOW 18,053.71 +23.50 0.13%
S&P 500 2,088.77 +6.89 0.33%
NASDAQ 4,806.8590 +33.3870 0.70%

Brokerage Partners

Rates from Bankrate.com

  • 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