Biopure Corp.
U.S. FDA maintains clinical hold on IND application for RESUS phase II/III trial of Hemopure
Published in FDA Law Weekly, November 17th, 2005
Biopure Corp. (BPUR) announced that following the submission of additional information by the Naval Medical Research Center (NMRC), the U.S. Food and Drug Administration (FDA) has maintained its clinical hold on the NMRC's investigational new drug application (IND) for the proposed RESUS phase II/III clinical trial of Hemopure [hemoglobin glutamer - 250 (bovine)] for out-of-hospital treatment of trauma patients.
The company also announced that it has received regulatory approvals in Belgium to initiate a phase II trial of Hemopure in coronary angioplasty patients and in South Africa to initiate a phase II trial in patients undergoing lower limb amputation.
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Source: FDA Law Weekly (2005-11-17)
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