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Affymax Reports Phase 2 Clinical Dose Ranging Results of,Once-Per-Month Hematide for the Treatment of Anemia

PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 25, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced that additional Phase 2 clinical trial results for Hematide(TM) were presented at the European Renal Association-EDTA Congress being held in Barcelona, Spain by Iain C. Macdougall, M.D., a Hematide investigator from Kings College, London. Dr. Macdougall's poster included data in previously-treated dialysis patients and treatment naive, non-dialysis patients which demonstrated that mean hemoglobin (Hgb) levels could be maintained and corrected, respectively, with once monthly Hematide.

Specifically, the data showed that in non-dialysis patients an initial range of doses from .025 mg/kg to .075 mg/kg of Hematide, in conjunction with dose adjustments, is adequate to increase Hgb in anemic patients with renal failure when administered monthly. In addition, intravenous and subcutaneous dosing appeared to result in a similar Hgb increase.

"These data support further investigation of the versatility and flexibility of once-per-month Hematide in terms of starting doses and route of administration," said Robert Naso, Ph.D., executive vice president of Research and Development at Affymax. "These results demonstrate that a narrow target range of hemoglobin levels can be reached with different initial Hematide doses. We are pleased to have such thorough evaluation of the product as we prepare for pivotal Phase 3 clinical trials."

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 179 patients who had mostly completed six months of treatment at European and U.S. clinical sites. Of those, 89 treatment-naive CKD patients who were not on dialysis in the correction study were treated with Hematide once every four weeks. The me
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