Affymax (AFFY) Announces Results From Phase 2 Clinical Trial of Hematide for the Treatment of Anemia in Dialysis Patients
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Affymax, Inc. (Nasdaq: AFFY) announced that results available from its Phase 2 clinical trial of Hematide dosed monthly in dialysis patients were presented this week at the National Kidney Foundation (NKF) 2007 Spring Clinical Meeting.
The results from this maintenance-switch trial in patients previously treated with three-times weekly Epoetin Alfa (EPO) demonstrated that mean hemoglobin (Hgb) levels can be maintained at clinically acceptable levels following a switch to once-monthly treatments with Hematide at an appropriate dosing regimen.
"These data are encouraging and show that patients can be switched from a regimen of EPO three-times weekly to once monthly Hematide in a controlled fashion where hemoglobin levels were maintained within 1 g/dL of baseline at an appropriate dosing regimen," said Dr. Besarab. This is especially important given the growing concerns related to excessive hemoglobin increases due to erythropoiesis stimulating agent use."
The Phase 2 trial, which involved 165 patients, was an open label, multi-dose study conducted to assess safety, pharmacodynamics and pharmacokinetics of Hematide in hemodialysis patients with stable baseline Hgb levels between 10 and 12.5 g/dL on previous Epoetin Alfa therapy. The endpoints were Hgb and reticulocyte levels, Hematide dose adjustments and red blood cell transfusions. In addition, adverse and serious adverse events were monitored.
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