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

uma trial. In carrying out that agreement, the Navy designed and submitted to the FDA a proposed phase 2/3 trial entitled "Restore Effective Survival in Shock" (RESUS). That trial would have been conducted prehospital in civilian trauma patients. The trial was placed on clinical hold by the FDA and continues to be on hold following changes intended to address FDA comments. The newly filed protocol, by incorporating informed consent, is intended to remove requirements attendant to waiver of informed consent. To date, Congress has appropriated a total of $24.2 million for the development of Hemopure.

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.

Statements in this release that are not strictly historical are forward- looking statements, including any statements implying that any clinical trial will be initiated and/or carried out to completion or that study results will be as desired, and any statements that might imply that Hemopure may receive marketing approval in any jurisdictions other than South Africa or for a trauma indication anywhere. Actual results and their timing may differ materially from those projected in these for
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SOURCE Biopure Corporation
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