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| |  Hemopure Eliminates Need For Allogeneic Red Blood Cell Transfusions In Many Patients CAMBRIDGE, MA -- February 11, 2000 -- Biopure Corporation's investigational oxygen therapeutic, Hemopure® [hemoglobin glutamer - 250 (bovine)] or HBOC-201, has been shown to eliminate allogeneic red blood cell transfusions in a significant number of patients undergoing vascular surgery, according to clinical trial results published today in the peer-reviewed Journal of Vascular Surgery. Results from the single-blind Phase II study also showed that the product was well tolerated in a patient population consisting largely of elderly patients with complex medical conditions. "This oxygen therapeutic solution eliminated intra and postoperative red blood cell transfusions in more than a quarter of these high-risk patients despite study design restrictions on the total dose and number of days over which the product could be administered," stated Glenn M. LaMuraglia, M.D., the principal investigator at the Division of Vascular Surgery, Massachusetts General Hospital, one of eight hospitals that participated in the study. "These results further confirm that Hemopure provides an oxygen 'bridge' that can help stabilize anemic surgery patients who require immediate oxygen- carrying support." Seventy-two patients undergoing elective surgery for abdominal (infrarenal) aortic aneurysms were randomized (2:1) to receive either Hemopure or allogeneic red blood cells at the first transfusion decision during or after surgery. Forty-eight of these patients received an initial dose of two units of Hemopure and, if needed, up to three additional units within 96 hours. Patients requiring transfusions outside of these parameters were subsequently administered red blood cells. Twenty-four control group patients received only standard transfusions of allogeneic red blood cells. Results showed that Hemopure totally eliminated the need for red blood cell transfusions in 27 percent of patients throughout the entire 28-day follow-up period. Moreover, 39 percent of Hemopure patients did not require allogeneic blood during the 96-hour treatment period and 66 percent did not require allogeneic blood on the day of surgery, further supporting the product's use as an oxygen bridge. The hematocrit (red blood cell volume as a percentage of blood volume) was similar for both the Hemopure group of patients and the control group at the time of discharge from the hospital, suggesting that Hemopure may support the production of the patients' own red blood cells. The types and occurrence of serious adverse events were also similar for both groups of patients, with no allergic reactions. The incidence of mortality was 6 percent in the Hemopure group and 8 percent in the red blood cell control group. Each year in the United States, more than 12 million units of whole blood and red blood cells are transfused into an estimated 4 million patients, approximately 3 million of which are surgery patients. In many cases, allogeneic red blood cells are transfused to reduce anemia -- a deficiency of red blood cells or hemoglobin (the protein in red blood cells that carries oxygen). This condition compromises the oxygen-carrying capacity of blood and creates an oxygen deficiency in tissues, which in severe cases can cause organ dysfunction, tissue damage or death. To date, Hemopure has been administered to more than 600 patients in 21 completed or ongoing clinical trials. Biopure's four advanced trials in elective surgery represent a logical progression that has expanded the product's dosing limits from 4 units administered postoperatively over a 3-day period to 10 units administered perioperatively over six days in an ongoing, pivotal Phase III trial in orthopedic surgery. One unit of Hemopure contains 30 grams of ultrapurified, chemically cross-linked hemoglobin in 250 milliliters of a balanced salt solution. This linked hemoglobin circulates in the plasma (the fluid part of blood) when infused, and has a lower viscosity (resistance to flow) and more readily releases oxygen to tissues than blood. Hemopure is uniquely stable at room temperature for at least 30 months, is compatible with all blood types, and is purified through patented techniques that are validated to remove infectious agents, including bacteria, viruses, prions and other potential contaminants. Related links:Hemopure, Biopure Corporation.
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