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Article: Osiris Setback in Phase III - Analyst Blog
- Article from:
- Zacks Investment Research - Analyst Blog
- Article date:
- March 27, 2009
- Author:
CopyrightCopyright 2009 Zacks Investment Research. (Hide copyright information)
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Osiris Setback in Phase III - Analyst Blog
Highlights include Osiris Therapeutics, Inc. (
OSIR
) and Genzyme Corp. (
GENZ
).
Management Halts Phase III Crohn's Trial Due to Design Flaw
On March 27, 2009,
Osiris Therapeutics
(
OSIR
) announced it was stopping its phase III clinical trial program testing Prochymal for the treatment of acute Crohn's disease (CD) due to a design flaw in the trial that was allowing for significantly higher-than-expected placebo response rates.
The decision was made after the trial's final scheduled interim analysis showed that 1 of the 2 Prochymal dose arms had crossed a futility boundary (would not achieve
statistical significance).
As a reminder, Osiris' phase III CD ...