Northfield Laboratories Inc announced that the independent data monitoring committee (IDMC) has recommended that the Company's pivotal phase III trial with PolyHeme continue without modification following the second planned interim analysis of the study.

The IDMC stated, "There are no concerns to alter the protocol" after a review of blinded data on mortality and serious adverse events in the first 120 patients enrolled in the study. This is the first time a blood substitute has successfully passed this patient evaluation milestone in a phase III clinical trial in the high-risk trauma population, Northfield Laboratories said in a release.

The pivotal phase III study is designed to evaluate the safety and efficacy of PolyHeme, Northfield's human haemoglobin-based oxygen carrier, when administered to patients in hemorrhagic shock following traumatic injury. It is the first study in the US in which treatment with a blood substitute begins at the scene of injury. Patients are currently being enrolled at Level I trauma centres throughout the United States, with a target enrolment of 720 patients. The primary endpoint is survival at 30 days.

"Northfield has reached another significant milestone in this pivotal trial," said Steven A Gould, chairman and CEO. "We are encouraged by this second positive recommendation of the IDMC, which once again confirms the attention to patient safety that characterizes the efforts of all involved in this complex study. This trial is an important step towards achieving our goal of bringing PolyHeme to market as the first blood substitute approved for use in urgent, life-threatening haemorrhage. We look forward to providing additional updates as the trial progresses," he added.

The IDMC is a group of experts responsible for periodically evaluating the safety data from the study and making recommendations relating to the continuation or modification of the study to minimize any identified risks to patients.

Northfield Laboratories Inc is a leader in developing an oxygen-carrying blood substitute, PolyHeme, for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings. PolyHeme is a solution of chemically modified human haemoglobin that requires no cross matching and is therefore compatible with all blood types. It has a shelf life of over 12 months, the company says.