Northfield Laboratories to continue phase 3 PolyHeme study without changes

By Jennifer Chiou

New York, Nov. 15 - Northfield Laboratories Inc. announced the Independent Data Monitoring Committee has recommended its phase 3 trial with PolyHeme continue without modification.

In the fourth planned interim analysis of the study, the committee reviewed blinded data on mortality in the first 500 patients enrolled in the study.

"This is a key milestone for Northfield and our development of PolyHeme," chairman and chief executive officer Steven A. Gould said in a news release.

"We are extremely pleased with this fourth recommendation. Northfield has made sustained progress in the trial this year and we are looking forward to completing enrollment early next year."

Northfield's study evaluates the safety and efficacy of PolyHeme, a human hemoglobin-based oxygen- carrying resuscitative fluid that is administered to patients in hemorrhagic shock following traumatic injury.

Evanston, Ill.-based Northfield Laboratories develops treatments for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings.

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