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Northfield Laboratories Reports Results of Pivotal Phase III Trauma,Study

The incidence of cardiac AEs was 35% (123 patients) in the PolyHeme group and 29% (105 patients) in the control group (pgreater than0.05). The incidence of cardiac SAEs was 7% (23 patients) in the PolyHeme group and 4% (16 patients) in control (pgreater than0.05). The overall incidence of MI in the study as reported by investigators was 2%: eleven PolyHeme patients and three control patients (p(less than or =)0.05). Three PolyHeme patients and one control patient died.

The medical literature documents the difficulty of making an accurate diagnosis of MI in trauma patients for multiple reasons, including direct trauma to the chest. Myocardial infarction and myocardial ischemia are traditionally assessed by EKGs and the cardiac enzymes Troponin I and CK-MB, both of which can be altered by direct trauma. Approximately 75% of the patients in this study had abnormal EKGs or elevated cardiac enzymes. Because of the disparity between the low number of reported MIs and the high incidence of abnormal EKGs and elevated cardiac enzymes, Northfield has established an independent panel of cardiac experts to review the cardiac profiles of all 720 randomized patients in a blinded fashion to categorize MIs in the study.

Summary

"This was a seminal study. This summary represents our initial opportunity to explore the data on safety and efficacy in detail. We continue to believe there is a potential benefit to using PolyHeme in patients with delayed access to blood, whose expected mortality without oxygen-carrying replacement would be considerably greater," said Dr. Gould.

As the data have not been submitted to FDA, Northfield is preparing a detailed summary of the study data for submission to FDA for review.

About the Study

This randomized, controlled open-label, multi-center, active control pivotal Phase III study of 720 patients was designed to evaluate the safety and efficacy of PolyHeme when used to treat patients in hemorrhagic shoc
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