"Based on my experience as a
clinical investigator I'm optimistic
about the potential use of this
compound in the United States
as an oxygen 'bridge' in elective
surgery patients who are acutely   
anemic."

Jonathan S. Jahr, M.D.
Professor of Anesthesiology,
Director of Clinical Research
Department of Anesthesiology
University of California, Los Angeles
January 2002
 
During the past 10 years, more than 1,300 patients have been enrolled and more than 800 patients have been administered Hemopure in 22 clinical trials in the United States, Europe, South Africa and Canada. These trials include four advanced, red blood cell controlled studies in cardiac, vascular, general and orthopedic surgeries. To ensure that only patients in need of a transfusion were entered into these advanced red blood cell controlled trials, each patient was randomly assigned to receive either Hemopure or allogeneic red blood cells at the first transfusion decision. In this respect, Biopure's trials are unique compared to other clinical studies completed to date for investigational oxygen therapeutics.

BLA FILING Biopure is currently expanding the production capacity of its Cambridge, Mass. manufacturing facility in preparation for the filing of an electronic Biologic License Application (eBLA) with the U.S. FDA in mid-2002, followed by an application in Europe. The proposed product indication is for perioperative use of Hemopure to eliminate or reduce red blood cell transfusions in patients undergoing elective surgery. This submission will exceed 350,000 pages and include data from two Phase III clinical trials.

NON-U.S. PHASE III TRIAL In February 2002, Biopure submitted final and addendum study reports to the FDA for a non-U.S. Phase III trial of Hemopure in patients undergoing general surgery. South Africa's Medicines Control Council granted marketing clearance for Hemopure in April 2001 on the basis of this Phase III trial and additional supportive data.

U.S. PHASE III TRIAL In 2001, Biopure announced that the primary study endpoints were met in a U.S. Phase III clinical trial of Hemopure in patients undergoing elective orthopedic surgery. The primary efficacy endpoint was the elimination of red blood cell transfusions, at 42 days post surgery, in at least 35 percent of patients receiving Hemopure. The primary safety endpoint was that patients treated with Hemopure have outcomes no worse than patients treated with red blood cells. This assessment was based on an independent safety endpoint evaluation committee's (SEEC) blinded review of each patient's case report form and medical records to determine the overall medical risk to patients receiving Hemopure versus donated blood.

In January 2002, University of California clinical investigator Dr. Jonathan S. Jahr reported the Phase III results from one U.S. trial site at the Society of Critical Care Medicine’s Annual Congress in San Diego, Cal. Further Phase III data will be presented at the International Anesthesia Research Society’s Clinical and Scientific Congress in March and in other medical forums during 2002 and 2003.