CAMBRIDGE, Mass., June 10 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that the results from its Phase III orthopedic trial (HEM-115) have been published in the June 2008 issue of the Journal of Trauma. This paper is entitled "HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery."
"It is gratifying to have experts cull through the complex data repeatedly until insight into our product emerged," said Dr. A. Gerson Greenburg, Biopure Vice President, Medical Affairs and the paper's senior author.
The study, HEM-115 that included nearly 700 patients from 46 sites on three continents, is the largest Phase III clinical trial of the safety and efficacy of an HBOC as an option to avoid packed red blood cells (PRBC) in elective orthopedic surgery patients. The trial was designed to safely reduce and/or eliminate perioperative transfusion in patients who were expected to require transfusion of at least two units of PRBC as part of their procedure.
The paper's authors concluded that HBOC-201 eliminated the need for transfusion in the majority of patients. Patients < 80 years of age with moderate clinical needs safely avoided transfusions when treated with up to 10 units of HBOC-201. The intent-to-treat analysis was unfavorable with the crossover group (HBOC-201 to PRBC) being identified as the primary basis for the difference. The analytical methodology used identified that the crossover patients had a greater need for an oxygen carrier, likely related to patient age, volume overload and under-treatment.
The manuscript was authored by the principal investigator Jonathan S. Jahr, MD of the David Geffen School of Medicine at UCLA; Colin Mackenzie, MD of the National Study Center for Trauma & EMS, University of Maryland et al.
Biopure Corporation develops, manufactures and markets pharmaceuticals,
called oxygen therapeutics, that are intravenously administered to deliver
oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250
(bovine)], or HBOC-201, is approved for sale in South Africa for the
treatment of surgical patients who are acutely anemic. The company is
developing Hemopure for other indications and is supporting the U.S. Navy's
government-funded efforts to develop a potential out-of-hospital trauma
indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer
- 200 bovine)], or HBOC-301, the only oxygen therapeutic approved for
marketing by both the U.S. Food and Drug Administration and the European
Commission, is indicated for the treatment of anemia in dogs. Biopure has
sold approximately 200,000 units of Oxyglobin since its launch.
Contact: Tiana Gorham
|SOURCE Biopure Corporation|
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