BIOPURE'S TRIAL OF HEMOPURE TO CONTINUE FOLLOWING DSMB REVIEW

Biopure has announced that the independent data and safety monitoring board (DSMB) for the company's Phase II clinical trial of Hemopure (hemoglobin glutamer [bovine]) in trauma patients has completed its first scheduled interim analysis of blinded study data and recommended that the trial continue without modification. The DSMB reviewed mortality and other safety data from the first 21 patients enrolled in this single-center trial at the Johannesburg Hospital Trauma Unit in South Africa.

The 50-patient, single-blind trial is designed to assess the safety and tolerability of 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 after the infusion.

The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues that would warrant modification of the protocol or early termination of the study. The next DSMB meeting is scheduled to occur after patient No. 38 is enrolled and has completed the 28-day follow up visit. After the trial is completed, the DSMB will meet again to review the data for all 50 enrolled, evaluable patients and assess the safety of the product.

Hemopure, or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. Biopure has applied in the UK for regulatory approval of Hemopure in an orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Navy's efforts to develop it for a potential out-of-hospital trauma indication.