FDA puts hold on Hemopure Phase IIb/III

Biopure (BPUR) said FDA placed a clinical hold on the Phase IIb/III RESUS trial of Hemopure hemoglobin glutamer to treat trauma patients prior to arrival at the hospital. BPUR is co-developing the product for trauma with the U.S. Naval Medical Research Center (NMRC), which submitted an IND for the trial last month. BPUR would not say when the parties will respond to FDA.

FDA's concerns were mainly related to safety. The agency has requested dosing instructions for administering Hemopure in the ambulance setting in trauma patients with volatile blood pressure, as well as additional data on the proposed trauma population to demonstrate a reasonable risk/benefit ratio. The agency also has requested changes to the investigator brochure and other materials to include additional safety data. ...