Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., today announced data from multiple clinical and preclinical studies evaluating Hematide, including preliminary results of a Phase 2 trial which demonstrated that Hematide increased hemoglobin levels in a group of anemic hemodialysis (HD) patients. This is the first reported data from an open-label, controlled comparative study of once-monthly Hematide compared to three times per week epoetin alfa (EPO). These results were presented at the American Society of Nephrology (ASN) Renal Week 2009 in San Diego, CA. Separately, Hematide is currently being evaluated in four Phase 3 trials for the treatment of anemia associated with chronic renal failure.
Preliminary data from the Phase 2 randomized, active-controlled, open-label trial were presented in a poster entitled “Preliminary Analysis of Once-Monthly Hematide Efficacy and Safety in Hemodialysis Patients not on erythropoiesis stimulating agent (ESA) Treatment.” The trial enrolled 114 hemodialysis patients who were not actively undergoing ESA treatment. In these patients, hemoglobin levels were between 8.0 g/dL and 11.0 g/dL at baseline. According to the National Kidney Foundation, hemoglobin levels should generally be maintained in the range 11.0 g/dL to 12.0 g/dL. Patients were randomized to receive one of three starting doses: intravenous Hematide once every four weeks (0.04 mg/kg or 0.08 mg/kg) or intravenous EPO three times per week (50 U/kg). Preliminary results showed Hematide treated anemia as measured by increasing hemoglobin levels and maintaining them at the target range in this patient population. Moreover, patients in the Hematide group appeared to show treatment results comparable to patients in the EPO group.