Affymax, Inc. (AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., revealed data from a Phase 2 clinical trial of Hematide showing that Hematide increased hemoglobin and reduced or eliminated the need for blood transfusion in most patients with erythropoietin-induced pure red cell aplasia. In the open-label, non-randomized trial, patients with chronic kidney disease, who had anti-erythropoietin antibody-mediated PRCA and who were anemic, generally experienced increases in hemoglobin above 11 g/dL following once monthly injections of Hematide.
The company noted that thirteen of the 14 patients achieved the primary endpoint of an increase in hemoglobin to a level greater than 11 g/dL without the need for regular blood transfusions.
PRCA is a rare, serious and debilitating autoimmune disorder, which can occur when the body produces neutralizing antibodies against the currently marketed recombinant human erythropoietins.
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