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news.Hematide to treat anemia in chronic renal failure patients on dialysis or without dialysis
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Affymax has announced that the independent Data Monitoring Committee (DMC), which provides oversight for the Phase-III program for Hematid, has completed another review. DMC has informed the company that the cumulative safety data generated thus far from the Emerald and Pearl Phase-III trials, support continuation of the studies.
Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).
In the Phase-III program, Hematide is evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis.
The program, which consists of four trials, was initiated in October 2007. Affymax declared that enrollment was over in all four Phase-III trials in November 2008, and reiterated its expectation for a NDA submission in 2010.
Affymax, is a biopharmaceutical company engaged in the development of novel drugs for the treatment of serious and life-threatening conditions.