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FDA Advisory Committee To Consider Navy's Proposed 'Resus' Trauma Trial In Open Session On December

By: Hematology News

iopure Corporation (Nasdaq: BPUR) announced today that the Food and Drug Administration's (FDA) Blood Products Advisory Committee will meet in open session on December 14, 2006 to discuss the Navy's proposed RESUS clinical trial of Biopure's investigational oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury. FDA has invited the Naval Medical Research Center (NMRC) and Biopure to present at the meeting.

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. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to 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 by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs.

Statements in this press release that are not strictly historical are forward-looking statements, including any that might imply that the proposed RESUS trauma trial will receive authorization to proceed. Actual results and their timing may differ materially from those projected in these forward- looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company's financial position, unexpected costs and expenses, delays and determinations by regulatory authorities, and delays in or unpredictable outcomes of clinical trials. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of the company's operations and financial condition can be found in the company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Form 10-Q filed on September 11, 2006, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov.

The content of this press release does not necessarily reflect the position or the policy of the U.S. Government or the Department of Defense, and no official endorsement should be inferred.

Article Source: http://www.new.citynewslive.com

Biopure Corporation
www.biopure.com/

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