Northfield Labs completes enrollment in pivotal phase 3 trial of red blood cell substitute

By Lisa Kerner

Charlotte, N.C., July 31 - Northfield Laboratories Inc. said it completed patient enrollment in its pivotal phase 3 trauma study with PolyHeme, the company's human hemoglobin-based oxygen-carrying red blood cell substitute.

The PolyHeme trial, the first of its kind in the United States, will evaluate the safety and efficacy of an oxygen-carrying red blood cell substitute from surgery through the early hospital stay.

Northfield said it had a planned enrollment of 720 patients.

The primary endpoint of the trial is survival at 30 days.

"We are pleased to have completed enrollment in this complex phase 3 study - another key milestone in our progress toward bringing PolyHeme to market," chairman and chief executive officer Steven A. Gould said in a news release.

"We are eager to begin the data analysis, and look forward to reporting top-line results from the study in the fall."

Located in Evanston, Ill., Northfield is developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss.

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