The 100-patient clinical 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.
Biopure has also received regulatory authorizations in South Africa for this trial, in the UK for a proposed phase II cardiac surgery trial and in Belgium for a proposed phase II coronary angioplasty trial of the product. The company expects to initiate patient enrollment in these trials in late 2005 and early 2006.