Biopure and FDA to discuss AML use for Hemopure

USA-based Biopure Corp has had discussions with the Food and Drug Administration on identifying an acceptable patient population for a new clinical trial of its blood substitute Hemopure (hemoglobin glutamer - 250 [bovine]). Biopure has proposed to study use of its product in patients suffering from acute myelogenous leukemia who refuse transfusion with blood components.

Currently, AML patients who do not accept blood transfusions are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes. Biopure is preparing to submit a protocol for such patients for consideration by the agency. Patients would give informed consent before being enrolled in this study. An effective treatment for this population represents an unmet medical need because of an expected 100% mortality within six months in the absence of induction chemotherapy.

The purpose of the study would be to assess the efficacy of Hemopure in providing an oxygen carrier instead of transfusion with red blood cells, as an adjunct to other special procedures, following induction chemotherapy for AML. A successful trial in this population could be pivotal to establish an intended use for Hemopure in this clinical setting, the firm noted.