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

including a platform for moving forward with its Hemopure product. Dr Greenburg noted first, that future trials should exclude competition with packed red blood cells. and target use where blood is not an option or not available. Furthermore, the safety profile of each member of the class of HBOCs should be evaluated individually. He also presented results of analysis of the company's surgical orthopedic trial, HEM- 0115, which will be published in the Journal of Trauma. Dr. Greenburg's presentation is available on Biopure's website.

The day before the workshop, the Journal of the American Medical Association (JAMA) published a meta-analysis of HBOCs as a class. At the workshop, one of the article's authors presented the findings, which raised questions about safety signals in the absence of clinical benefit shown in some of the trials in the meta-analysis. Dr. Greenberg stated that the different compositions of the HBOCs considered, including some no longer in development, invoke a principle of heterogeneity that would argue against any comparisons made from combining data.

Experts presenting at the workshop repeatedly opined that FDA should permit carefully designed randomized controlled clinical trials of the current generation of HBOCs in patients with life-threatening anemia who do not have the option of a blood transfusion. Dr. Colin MacKenzie of the University of Maryland chaired a symposium prior to the workshop during which clinicians discussed their experience with the clinical use of Hemopure in South Africa and in compassionate use patients, approved on an individual basis by the FDA. This symposium is available at the University of Maryland website at http://hfrp.umm.edu/cucases .

Dr. Demetrios Demetriades, Professor of Surgery and Director of Trauma and Surgical Intensive Care Unit, University of Southern California School of Medicine, suggested that the products might be made
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SOURCE Biopure Corporation
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