Northfield completes Ph II PolyHeme enrollment

Illinois, USA-based Northfield Laboratories says that patient enrollment is complete in its pivotal Phase III trauma study with PolyHeme, its human hemoglobin-based oxygen-carrying red blood cell substitute.

"We are pleased to have completed enrollment in this complex Phase III study - another key milestone in our progress toward bringing PolyHeme to market," said Steven Gould, chief executive, adding: "we are eager to begin the data analysis, and look forward to reporting top-line results from the study in the fall."

The PolyHeme trial is the first study in the USA designed to evaluate the safety and efficacy of an oxygen-carrying red blood cell substitute beginning at the scene of injury and continuing during transport and in the early hospital period. The study had a planned enrollment of 720 and was conducted at major Level I trauma centers throughout the USA. The primary endpoint is survival at 30 days.