CLINICAL TRIAL OF HEMOPURE RECEIVES UK REGULATORY AUTHORIZATION

Biopure has received regulatory authorization in the UK to initiate the Phase II clinical trial of its investigational oxygen therapeutic Hemopure (hemoglobin glutamer) in patients undergoing lower limb amputation.

The trial is randomized, multicenter, single-blinded, parallel-group, and placebo-controlled, and involves 100 patients. It 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.