May 29, 2007 — Northfield Laboratories Inc. has reported results of its pivotal Phase III trauma trial with PolyHeme, a human hemoglobin-based, oxygen-carrying red blood cell substitute.
The trial was designed to seek an indication for use in the treatment of life-threatening red blood cell loss when transfusion is required and red blood cells are not available, not for use interchangeably with blood. This indication addresses a critical, unmet medical need.
According to a report by Associated Press, safety results fell short in the study and included more heart attacks and deaths than patients in the control group that received blood and saline. The study followed 720 patients.
The primary efficacy endpoint of the study was a dual superiority-noninferiority assessment of mortality at 30 days after injury. The margin to assess noninferiority, using the upper limit of the confidence interval, was set at 7 percent more than control. In the primary Modified Intent to Treat population, the upper limit was 7.65 percent. In the As Treated population, the upper limit was 7.06 percent. In the Per Protocol population, the upper limit was 6.29 percent.
Day 30 mortality was also a primary safety endpoint. Further analysis of the mortality data indicates that 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.
"The results of this study are best understood in the context of bleeding patients who do not have early access to blood transfusion," said Steven A. Gould, M.D., chairman and chief executive officer. "Forty-seven million Americans live more than an hour away from a trauma center where blood is available. Mortality rates in that scenario would be considerably higher than those observed in the control patients in the urban setting of this trial, where transit times were relatively short. We believe that when our data are extrapolated to patients who need an oxygen carrier and have delayed access to blood, PolyHeme can play an important role in saving lives."
For more information, visit www.northfieldlabs.com.