Northfield Laboratories releases extended summary from PolyHeme trial

By Elaine Rigoli

Tampa, Fla., March 21 - Northfield Laboratories, Inc. announced Tuesday that in light of heightened interest in its phase 3 elective surgery trial with PolyHeme conducted in the late 1990s, the company would provide an extended summary of the major observations immediately.

In a company news release, Northfield described the objectives of the study, the study design, the procedure of acute-normovolemic hemodilution (ANH), the population studied and the major safety and efficacy observations.

Key points about the study and summary observations include the following:

• The study was designed to assess whether the use of PolyHeme would allow an increase in the volume of autologous blood collected during ANH and therefore avoid transfusion of donated blood;

• The study demonstrated that a greater volume of the patient's blood could be collected during ANH with the use of PolyHeme;

• The study did not achieve its objective of avoiding transfusion of donated blood;

• The algorithm in the protocol resulted in multiple treatment differences between the two groups in the study;

• Ten patients in the treatment group experienced myocardial infarction versus none in the control group;

• Two of these patients died, at seven and 32 days.

The cardiovascular events noted differed from past trauma experience in which PolyHeme was given in doses up to 20 units and was well-tolerated, the release said.

The company said it cannot be determined whether the cardiovascular events were due to the more extensive ANH in the treatment group, to the reinfusion of more blood following surgery in the treatment group or to PolyHeme itself, according to the release.

Northfield does not believe the cardiovascular events were due to a direct pharmacologic effect of PolyHeme, but to complex fluid-management issues in these patients, the release said.

Northfield Laboratories, located in Evanston, Ill., develops oxygen-carrying resuscitative fluid, PolyHeme, for the treatment of urgent, large-volume blood loss in trauma and resultant surgical settings.

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