Northfield Laboratories completes enrollment in pivotal phase III PolyHeme® Trial
Northfield Laboratories Inc. (NASDAQ: NFLD) announced that patient enrollment is complete in its pivotal Phase III trauma study with PolyHeme®, the Company’s human hemoglobin-based oxygen-carrying red blood cell substitute.
Methodist Hospital, Clarian Health Partners and Wishard Memorial Hospital, Wishard Health Services in Indianapolis, Indiana, in partnership with the Indiana University School of Medicine, were among 32 sites conducting a study testing PolyHeme®, a solution of chemically modified human hemoglobin in trauma patients who are suffering from massive blood loss.
“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 A. Gould, M.D., Chairman and Chief Executive Officer. “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 U.S. 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 United States. The primary endpoint is survival at 30 days.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. PolyHeme® is a solution of chemically modified human hemoglobin that requires no cross matching and is therefore compatible with all blood types. It has a shelf life in excess of 12 months. For further information, visit www.northfieldlabs.com.