PolyHeme May Reduce Post-injury Immune Response in Trauma Patients; Literature on Blood Substitutes Continues to Expand

EVANSTON, Ill. -- Northfield Laboratories Inc. announced today the publication of an original scientific article describing a potential benefit of PolyHeme, the company's oxygen-carrying blood substitute, in modulating the immune response in critically injured trauma patients.

The article, "Alteration of the Postinjury Hyperinflammatory Response by Means of Resuscitation with a Red Cell Substitute," was published in the January 2003 issue of The Journal of Trauma. The manuscript provides the full details of this preliminary study that was initially presented in September 2002 at the 61st annual meeting of the American Association for the Surgery of Trauma. The paper was authored by Jeffrey L. Johnson, MD, Ernest E. Moore, MD, Christopher C. Silliman, MD, PhD and colleagues at Denver Health Medical Center, the Bonfils Blood Center and the University of Colorado Health Sciences Center. Moore has been the lead investigator in Northfield's clinical trials to assess the role of PolyHeme in the treatment of trauma patients.

"This is another important piece of work by Dr. Moore and his associates, who were the first investigators to observe that early red cell transfusion was an independent risk factor for the development of multiple organ failure (MOF) in trauma patients," commented Steven A. Gould, MD, chairman and CEO of Northfield. "Since MOF is an important cause of late post-injury mortality, this is a key finding. Their ongoing studies have suggested that a hyperinflammatory response following early red cell transfusion may be a contributing factor in the genesis of MOF. The use of PolyHeme provided a unique opportunity to assess the inflammatory state of patients in whom red cell transfusion was avoided in the early post-injury period."

The results of the study confirm their prior observations that patients transfused with stored blood develop an increased inflammatory response. In contrast, the patients resuscitated with PolyHeme in lieu of red cells demonstrated a more modest postinjury immune response. Although these findings suggest that the early use of PolyHeme rather than blood might decrease the likelihood of post-injury MOF and subsequent mortality, this preliminary study of only 25 patients was too small for a meaningful assessment of a potential difference in survival.

"Northfield's prior studies in hospitalized trauma patients have demonstrated the life-sustaining oxygen-carrying capability of PolyHeme during massive blood loss," Dr. Gould added. "Our pending civilian ambulance trial will allow the potential immunomodulatory effect of PolyHeme to be more fully assessed in a prospective, controlled fashion," he concluded.

PolyHeme is also discussed in a review article, "Hb-based Oxygen Carriers: Are We There Yet?" published in the February 2003 issue of Transfusion. This comprehensive review of the development and current status of hemoglobin-based oxygen carriers was written by Thomas J. Reid, MD, PhD, in response to an important case report published in Transfusion in November 2002. In that report, Sophie Lanzkron, MD and colleagues reported on the use of PolyHeme in a patient with severe complications associated with sickle cell disease, concluding that PolyHeme therapy saved the life of the patient.

Source: Northfield Laboratories Inc.

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