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Biopure Announces 2007 Third Quarter Financial Results
Date:8/23/2007

for each new case. To date, the FDA has approved all requests for compassionate use and granted 20 single-patient INDs to Biopure for the treatment of individual patients with life-threatening anemia when red blood cell transfusion was not an option. Thirteen patients have been treated for acute anemia resulting from blood loss or chemotherapy treatment.

U.S. Navy Program.

Following recommendations by the FDA Blood Products Advisory Committee (BPAC) meeting held in December 2006, the Navy Medical Research Center (NMRC) with support from Biopure submitted last month a new RESUS (Restore Effective Survival in Shock) study protocol for a Phase 2 out-of-hospital trauma study of Biopure's oxygen therapeutic Hemopure. In a recent letter to the NMRC, the FDA has kept the revised study protocol for RESUS on clinical hold. Biopure is still evaluating the letter and anticipates having further discussions with the NMRC and the FDA in the near future on this subject.

Ongoing Trials

Based on pre-clinical studies, the company believes that Hemopure can help improve tissue oxygenation, organ function and/or wound healing by transporting oxygen through constricted or partially blocked arteries and improving collateral circulation to oxygen-deprived tissues. A 60-patient clinical trial in patients undergoing multi-vessel coronary artery bypass graft (CABG) surgery continues to enroll patients in South Africa, Greece and the U.K. and has enrolled 33 patients. The objective of this trial is to assess the safety and feasibility of Hemopure in reducing heart damage, as measured by cardiac enzyme elevation, and enhancing tissue preservation during CABG surgery. In the Netherlands an 8 patient phase 2 safety and feasibility study in patients with multi-vessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI), also continues to enroll patients. This trial is testing the hypothesis that Hemopure may improve oxygenation and heart func
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SOURCE Biopure Corporation
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