Biopure receives OK for phase II trial of Hemopure in U.K. amputation patients

By E. Janene Geiss

Philadelphia, Nov. 2 - Biopure Corp. announced Wednesday that it has received regulatory authorization in the United Kingdom to initiate the phase II clinical trial of its investigational oxygen therapeutic Hemopure in patients undergoing lower-limb amputation.

The 100-patient trial is designed to assess the product's safety and feasibility in increasing the incidence of complete wound healing and reducing the incidence of subsequent amputations in patients with severe peripheral vascular disease who are undergoing lower-limb amputation below or through the knee joint, company officials said in a news release.

The U.K. Medicines and Healthcare products Regulatory Authority authorized the protocol for the randomized, multi-center, single-blinded, parallel-group, placebo-controlled clinical trial, officials said.

Biopure said it already has regulatory authorizations in South Africa for this trial, in the United Kingdom for a proposed phase II cardiac surgery trial and in Belgium for a proposed phase II coronary angioplasty trial of this product.

Officials said they expect patient enrollment for these trials in late 2005 and early 2006.

Cambridge, Mass.-based Biopure develops and manufactures intravenously administered pharmaceuticals, called oxygen therapeutics, that deliver oxygen to the body's tissues.

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