A Medical Device Daily

Biopure (Cambridge, Massachusetts)reported that the independent Data and Safety Monitoring Board (DSMB) for the company’s Phase II clinical trial of Hemopure [hemoglobin glutamer -250 (bovine)] in trauma patients has completed its first interim analysis of blinded study data and recommended that the trial continue unchanged.

The DSMB reviewed mortality and safety data from the first 21 patients in the single-center trial at Johannesburg Hospital Trauma Unit , South Africa.

The 50-patient, single-blind Phase II trial is assessing Hemopure, in a hospital setting, for emergency treatment of unstable patients who have significant blood loss as a result of blunt or penetrating trauma. Patients are randomly assigned to receive either standard therapy resuscitation fluids (crystalloids, colloids and/or blood) or up to 10 units of Hemopure plus standard therapy.

The treatment period for administering Hemopure is up to four hours from the first infusion. Patients are monitored until discharged from the hospital and at 28 days post-infusion.

The next DSMB meeting is scheduled after patient No. 38 is enrolled and has completed a 28-day follow up. After the trial completion, the DSMB will meet to assess the safety of the product. The trial has enrolled 23 patients to date.

Biopure is a developer of oxygen therapeutics.