CAMBRIDGE, Mass., March 1 /PRNewswire/ -- Biopure Corporation (Nasdaq: BPUR) today announced that its investigational oxygen therapeutic, Hemopure® [hemoglobin glutamer - 250 (bovine)], has been shown to restore and sustain brain oxygenation, blood pressure and cardiac output following severe hemorrhagic shock, according to the final results of a preclinical pharmacology study presented today by researchers at the 30th Annual Scientific Meeting of the Western Trauma Association in Squaw Valley, Lake Tahoe, Calif. The study was conducted in an animal model designed to simulate what happens to humans after an accident.

''In this study, Hemopure delivered oxygen to the brain rapidly and efficiently with minimal fluid administration following severe hemorrhagic shock,'' stated Geoffrey T. Manley, M.D., Ph.D., the study's principal investigator and a neurosurgeon at the San Francisco Injury Center, University of California San Francisco. ''These results suggest that this oxygen therapeutic may be an ideal fluid for rapid and early cerebral resuscitation, particularly in the pre-hospital arena where small volume administration may provide adequate oxygen and pressure support during transport and initial hospital management.''

The researchers evaluated the effect of Hemopure on brain oxygen tension (a measure of brain oxygenation), mean arterial pressure and cardiac output in hemorrhaged swine who had lost an estimated 42 percent of their total blood volume. Following blood loss, administration of high flow oxygen increased the mean brain oxygen tension from 6.9 mm Hg (+/- 4.8) to 14.4 mm Hg (+/- 4.4). A subsequent, one-time, small-volume administration of Hemopure (6 ml/kg) further increased (p<.01) brain tissue oxygen tension to 42.6 mm Hg (+/- 4.8), representing a 65 percent overshoot from the baseline. Mean arterial pressure also increased to 83 percent of baseline and cardiac output to 84 percent of baseline within 25 minutes of administration. These oxygen tension and cardiac output levels were maintained and blood pressure returned to baseline during a two-hour observation period.

By demonstrating that Hemopure restored brain oxygen tension and hemodynamic parameters and stabilized the hemorrhaged animals, these final study results reaffirm the preliminary results presented last year at the 27th Annual Meeting of the International Society on Oxygen Transport to Tissue.

Hemorrhagic Shock

Hemorrhagic shock is a state of physical collapse and helplessness caused by the sudden and rapid loss of significant amounts of blood. Severe injuries often cause such blood losses, which in turn produce hypoxia (oxygen deprivation) and hypotension (low blood pressure). Organ dysfunction, tissue damage and death can occur within minutes unless transfusion is quickly given to restore normal blood volume.

Blood transfusions are generally not available before a trauma victim reaches the hospital. Consequently, the current therapy for hemorrhagic shock is aggressive fluid resuscitation to restore hemodynamic parameters such as blood pressure and cardiac output. However, this approach has recently been shown to be detrimental in some trauma patients without head injury, while exacerbating cerebral edema (fluid retention) in patients with head injury.

Hemopure is a sterile oxygen therapeutic solution consisting of 30 grams of ultrapurified, chemically cross-linked hemoglobin in 250 milliliters of a balanced salt solution similar to Ringer's lactate. These linked hemoglobin molecules are not contained within a cell membrane, are much smaller than red blood cells, circulate in plasma (the fluid part of blood) when infused, and have a lower viscosity (resistance to flow) and more readily release oxygen to tissues (P50 of 38 mm Hg) than blood. Consequently, they can carry oxygen at low pressure and have been shown to carry oxygen through constricted or partially blocked blood vessels to tissues that are difficult for larger red blood cells to reach.

Hemopure is also 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.

Biopure Corporation

Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and marketer of pharmaceuticals called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues. Hemopure® [hemoglobin glutamer - 250 (bovine)] is an investigational product being evaluated for human use in a pivotal U.S. Phase III clinical trial as a perioperative alternative to red blood cell transfusion in orthopedic surgery. Other studies are evaluating the product's use in trauma, in ischemic conditions such as heart attack and stroke, and in hypoxic tumors. Oxyglobin® [hemoglobin glutamer - 200 (bovine)], the only oxygen therapeutic of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United States for the treatment of anemia in dogs.

Biopure's U.S. and foreign patents cover the manufacture of ultra-pure and room temperature stable hemoglobin solutions and their use as oxygen therapeutics. Key claims in the U.S. patents are not limited by the hemoglobin source (e.g., animal, human or genetically derived).