DMC says Affymax' Ph III Hematide study should proceed

US firm Affymax says that the independent Data Monitoring Committee, which provides oversight for the Phase III program for Hematide, a synthetic PEGylated peptidic compound under development with Japan's Takeda, has completed its first review of the data and 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.

"These are very important reviews by the DMC and we are pleased that the committee has recommended that the trials proceed," said Arlene Morris, chief executive of Affymax, adding: "we continue to make progress in enrollment of patients in the four Phase III trials and look forward to additional DMC reviews as more data are generated."

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 those trials. The company continues to enroll in the other three studies and anticipates completion of enrollment by year-end.