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Affymax Announces Phase 2 Clinical Trial Results of Once-Per-Month,Hematide for the Treatment of Anemia in Patients with Early- and,End-Stage Chronic Kidney Disease

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 23, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced results to date from two separate Phase 2 clinical trials of Hematide(TM) in dialysis and non-dialysis chronic kidney disease (CKD) patients. The data showed that in treatment naive, non-dialysis patients Hematide could correct anemia when administered monthly at an appropriate dose. Similarly, the data in dialysis patients previously treated with three-times weekly Epoetin Alfa demonstrated that mean hemoglobin (Hgb) levels could be maintained at clinically acceptable levels following a switch to once monthly dosing of Hematide at an appropriate dose. The data were presented by Iain C. Macdougall, M.D. at the World Congress of Nephrology meeting being held in Rio de Janeiro.

"These data show that Hematide results in appropriate management of hemoglobin levels in a broad spectrum of patients with CKD from early-stage patients not on dialysis to patients with end-stage renal disease requiring continuous dialysis support," said Dr. Macdougall. "Anemia is a pervasive problem in the chronic kidney disease patient population. Being able to manage and control anemia allows treating physicians to focus attention on management of the patient's underlying renal disease."

At the time of the presentation, the data generated to date were from two multi-center, open-label studies that have enrolled a total of 304 patients. Safety data were based on the entire patient population, while pharmacodynamic data were based on 180 patients who had mostly completed six months of treatment at European and U.S. sites.

Of those, 90 treatment naive CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The mean Hgb level was 10.2 g/dL at study entry and was increased to greater than 11 g/dL following an initial dose of Hematide. In the maintenance-conversion study, 90 patie
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