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U.S. Navy Submits Protocol for Field Trauma Trial of Hemopure(R)
Date:6/18/2008

CAMBRIDGE, Mass., June 18 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted a new protocol for review by the Food and Drug Administration (FDA) for a Phase 2 clinical trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, for resuscitation of operational casualties with severe traumatic hemorrhagic shock without availability of blood transfusions. The proposed trial hypotheses is that for such casualties Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with "standard fluid." Subjects will sign an informed consent prospectively. The study is entitled "Operational Restore Effective Survival in Shock (Op RESUS).

Op RESUS is designed as a single-blinded, randomized and controlled trial with up to 340 evaluable subjects, including operational military and civilian personnel (Department of Defense health system eligible). The primary aim of the study is to compare the 28-day relative rate of death in patients receiving Hemopure versus the group of patients receiving the "standard fluid" for resuscitation (Hextend). Secondary and tertiary outcome measures are also defined. All subjects would receive blood transfusions, when indicated, upon availability.

A successful completion, if attained, of Op RESUS safety primary objectives is expected to support an application to the FDA for allowance to conduct a definitive Phase 3 trial and have potential to improve survival of hemorrhagic shock casualties.

Under a research agreement with Biopure, the NMRC has had primary responsibility for designing, seeking FDA acceptance of and directing a pivotal tra
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SOURCE Biopure Corporation
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