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
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
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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