Data from multiple clinical and preclinical studies evaluating Hematide announced

Oct 31 2009

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.

Further, after 12 weeks of treatment, the mean hemoglobin levels for all three patient groups increased from a mean overall baseline of 9.2 g/dL to the target range of 11-12 g/dL where it was maintained through the rest of the study. At the time of the preliminary analysis, 11% of patients had experienced a serious adverse event. These events included arteriovenous (AV) thrombosis and vitreous hemorrhage. A single serious adverse event considered treatment-related was a case of arteriovenous fistula thrombosis that occurred in the lowest dose of Hematide (0.04 mg/kg). Adverse events considered possibly treatment-related occurred in approximately 9% of the patients. Hypertension was the only treatment related adverse event that occurred in more than one patient (8% in the Hematide 0.04 mg/kg group, 3% in the Hematide 0.08 mg/kg group and 8% in the EPO 50 U/kg group).

“Anemia remains a significant co-morbidity of chronic kidney disease and is associated with increased rates of hospitalization and mortality,” said Anne-Marie Duliege, M.D., chief medical officer of Affymax, Inc. “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.