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Biopure Reaffirms Strategy Following Recent NIH/FDA Workshop
Date:5/7/2008

available for compassionate use in patients such as Jehovah's Witnesses, for whom blood transfusions are unacceptable. He conceded that there was a major unmet need for these products and that he felt "we are not there yet." Dr. Gus Vlahakes, Professor of Surgery, Harvard Medical School, and Chief of Cardiac Surgery , Massachusetts General Hospital and Co-Director of the Massachusetts General Hospital Heart Center, stated that, theoretically, HBOCs may have significant benefit in clinical settings where blood is not available, specifically in trauma and cardiac surgery.

Daniel Freilich, MD, CDR, MC, USN, and head of the hematomimetics program at the Naval Medical Research Center, presented his opinion that an optimization of study design and practice guidelines would enable clinical evaluation of the current generation of HBOCs with reasonable risk. To maximize the potential for benefit and minimize potential for harm, he suggested targeting a population younger than 70 who were seriously wounded and would most likely die in situations where blood is not available, such as on the battlefield. The Naval Medical Research Center has been attempting to conduct a clinical trial using Hemopure in out-of-hospital trauma patients.

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 E
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