Northfield Announces Results of Third Interim Analysis of PolyHeme Study

An independent data monitoring committee (IDMC) has recommended that Northfield Laboratories' pivotal Phase III trial with PolyHeme continue without modification following the third planned interim analysis of the study data.

The IDMC reviewed blinded data on mortality in the first 250 patients enrolled in the study. This is the first time a hemoglobin-based oxygen-carrying resuscitative fluid has successfully passed this patient evaluation milestone in a Phase III clinical trial in the high-risk trauma population.

The IDMC also conducted an adaptive sample size determination as specified in the trial protocol. A blinded power analysis was performed to determine if any increase in the sample size of the study was necessary. The assessment was based on a comparison between the mortality rate predicted in the protocol and the observed mortality rate in the trial to date. The IDMC has concluded that no adjustment in the number of patients to be enrolled in the study is required. Therefore, trial enrollment remains at a total of 720 patients.

The pivotal Phase III study is designed to evaluate the safety and efficacy of PolyHeme, Northfield's human hemoglobin-based oxygen-carrying resuscitative fluid, when administered to patients in hemorrhagic shock following traumatic injury. It is the first study in the United States in which treatment with an oxygen-carrying resuscitative fluid begins at the scene of injury. Patients are currently being enrolled at Level I trauma centers throughout the United States. The primary endpoint is survival at 30 days.