This Day On The Street
Continue to site
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

Athersys Announces FDA Authorization Of Phase II Clinical Trial For Inflammatory Bowel Disease With Pfizer Regenerative Medicine

CLEVELAND, Nov. 8, 2010 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) announced today that the U.S. Food and Drug Administration (FDA) has authorized commencement of a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem ®, Athersys' allogeneic investigational cell therapy product, for the potential treatment of ulcerative colitis. This Phase II clinical trial is expected to begin enrolling patients before the end of 2010 and is part of a collaboration between Athersys and Pfizer that the companies formed in December 2009 to develop MultiStem for the treatment of inflammatory bowel disease (IBD). 

The Phase II study will be a randomized, double-blind, placebo-controlled, multi-center study to investigate the safety and efficacy of MultiStem in subjects with moderate to severe ulcerative colitis. The trial is designed to include approximately 126 patients. Patients participating in the study will receive multiple doses of either MultiStem or placebo, administered over eight weeks. Clinical efficacy endpoints will be examined through week 16 with follow-up of patients for 12 months. The study will be conducted at clinical centers in North America and Europe. 

This is the fourth clinical study of MultiStem authorized by the FDA and the first in the autoimmune disease area. "This announcement demonstrates exciting progress, achieved within a year of launching the collaboration, and reflects the tremendous effort on the part of the teams at both organizations that are working together to advance this program in a focused and efficient manner," said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer of Athersys. 

"This is a very exciting day as we celebrate this milestone achieved with our collaborator Athersys," said Ruth McKernan, Senior Vice President and Pfizer Regenerative Medicine Chief Scientific Officer.  "The speed at which this has occurred is an indicator of the depth of the collaboration between the Pfizer Regenerative Medicine and Athersys teams.  We look forward to continuing to work together on this program."

1 of 2

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
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 16,749.20 -27.23 -0.16%
S&P 500 1,975.78 -11.27 -0.57%
NASDAQ 4,725.1930 -56.0710 -1.17%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs