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Article: Pivotal PolyHeme Trial Fails To Hit Endpoints, Hurting Northfield.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
Shares in Northfield Laboratories Inc. lost about half their value after further pivotal study analyses showed that the oxygen-carrying red blood cell substitute PolyHeme missed its dual primary efficacy endpoints of superiority and non-inferiority a month after injury, as well as its primary safety endpoint.
"The difference in mortality at 30 days between patients who received PolyHeme beginning at the scene and continuing for up to 12 hours following injury and control patients who received the standard of care, including early blood, was not statistically significant," Chairman and CEO Steven Gould said of the safety analysis during ...