Affymax, Takeda Report Preliminary Phase 2 Data For Hematide

Published: 30-Oct-2009

According to preliminaty data hematide increases hemoglobin in dialysis patients

Affymax and Takeda Pharmaceutical (Takeda) have reported 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.

Preliminary data from the phase 2 randomised, 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.” 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).

The phase 2 randomised, active-controlled, open-label trial enrolled 114 hemodialysis patients, who were not actively undergoing ESA treatment. In these patients, hemoglobin levels were between 8g/dl and 11g/dl at baseline.

In the study, patients were randomised to receive one of three starting doses: intravenous Hematide once every four weeks (0.04mg/kg or 0.08mg/kg) or intravenous EPO three times per week (50u/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.

Further, after 12 weeks of treatment, the mean hemoglobin levels for all three patient groups increased from a mean overall baseline of 9.2g/dl to the target range of 11-1g/dl where it was maintained through the rest of the study.

Anne-Marie Duliege, chief medical officer of Affymax, said: “In the preliminary analysis of this study to increase hemoglobin levels of anemic dialysis patients not on ESAs, Hematide, used once a month, appeared to have treatment effects comparable to epoetin alfa used three times per week. Additional clinical and preclinical studies with Hematide are being presented at the meeting. They include data from a phase 2 clinical trial evaluating Hematide’s ability to raise hemoglobin levels in patients with pure red cell aplasia (PRCA), as well as preclinical studies evaluating the immunogenicity, binding characteristics and mechanism of action of Hematide.

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