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news.Biopure, which develops, manufactures and markets pharmaceuticals called oxygen therapeutics, has reported positive results from its Phase III orthopedic trial.
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Biopure said that the study, HEM-115 that included nearly 700 patients from 46 sites in three continents, is the largest Phase III clinical trial of the safety and efficacy of HBOC-201 as an option to avoid packed red blood cells (PRBC) in elective orthopedic surgery patients.
The trial was designed to safely reduce and/or eliminate perioperative transfusion in patients who were expected to require transfusion of at least two units of PRBC as part of their procedure.
The study concluded that HBOC-201 eliminated the need for transfusion in the majority of patients. Patients less than 80 years of age with moderate clinical needs safely avoided transfusions when treated with up to 10 units of HBOC-201. The intent-to-treat analysis was unfavorable with the crossover group (HBOC-201 to PRBC) being identified as the primary basis for the difference.
The analytical methodology used identified that the crossover patients had a greater need for an oxygen carrier, likely related to patient age, volume overload and under-treatment.