Affymax (AFFY) Announces Another Data Monitoring Committee Review of Phase 3 Hematide Program
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Affymax, Inc. (Nasdaq: AFFY) announced that the independent Data Monitoring Committee, which provides oversight for the Phase 3 program for Hematide(TM), has completed another review and has informed the company that the cumulative safety data generated thus far from the EMERALD and PEARL Phase 3 trials support continuation of the studies. In the Phase 3 program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis.
The Phase 3 program, which consists of four trials, was initiated in October 2007. Affymax announced that enrollment was complete in all four Phase 3 trials in November 2008 and reiterated its expectation for a NDA submission in 2010.
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