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news.Affymax has received positive review from the independent data monitoring committee, which provides oversight for the Phase III program for Hematide, a synthetic, PEGylated peptidic compound that acts as an erythropoiesis stimulating agent.
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The committee 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. In the Phase III program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis.
The Phase III program, which consists of four trials, was initiated in October 2007. Recently, Affymax announced that enrollment is complete in Pearl 1, the first of the Phase III trials. The company continues to enroll in the other three studies and anticipates completion of enrollment by year end 2008.
Arlene Morris, president and CEO of Affymax, said: “We continue to make progress in enrollment of patients in the four Phase III trials and look forward to additional data monitoring committee reviews as more data are generated.”