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www.fdanews.com/articles/108569-first-of-four-phase-iii-clinical-trials-ready-to-start

First of Four Phase III Clinical Trials Ready to Start

July 15, 2008

Affymax’s has completed enrollment for its first Phase III clinical trial using Hematide to treat anemia in chronic renal failure (CRF) patients.

The trial is the first of four Phase III studies for the drug and has enrolled 475 nondialysis patients from more than 70 sites in the U.S. It will evaluate the safety and efficacy of Hematide compared with darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time.

Anemia in CRF can cause fatal damage to the heart and other organs of individuals with chronic kidney disease, which affects 20 million Americans, Affymax said.