Promising Trial Results for Oxygen Therapeutic

A phase III trial has shown that about 95% of patients undergoing elective orthopedic surgery who received an oxygen therapeutic called Hemopure avoided red blood cell transfusion for at least 24 hours, with more than 60% avoiding blood throughout the six-week study period. The 60% figure is significantly greater than the 35% minimum efficacy criterion specified in the study protocol and is the highest percentage reported to date for an oxygen therapeutic product in a clinical trial with a follow-up period of more than one week. The trial was conducted at 50 hospitals around the world.

Hemopure was developed by Biopure Corp. (Cambridge, MA, USA). Each unit consists of 30 g of hemoglobin that has been extracted from bovine red blood cells, ultra-purified, chemically cross-linked, and formulated in 250 ml of balanced salt solution. Hemopure circulates directly in plasma when infused and has lower viscosity and releases oxygen to tissues more efficiently than red blood cells, says Biopure. It is also compatible with all blood types, stable at room temperature, and purified through patented techniques that remove potential contaminants and infectious agents, including bacteria, viruses, and agents thought to cause variant Creutzfeldt-Jakob (vCJD), the human form of mad cow disease.

The Medicines Control Council of South Africa has approved Hemopure for the treatment of acute anemia and avoidance of red blood cells in adult surgery patients. During the next six months, Biopure will ship 2,000 units to South Africa at no cost for limited use to collect patient outcomes data and cost effectiveness. Biopure plans to launch Hemopure in South Africa on a commercial basis in 2002, following expansion of its manufacturing facility.

"These preliminary efficacy results reaffirm Hemopure's ability to meet patients' oxygen requirements when compatible red blood cells are not readily available or when there is a need or preference to avoid blood transfusions,” said Carl Rausch, chairman and CEO of Biopure.




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