Affymax announced that the independent Data Monitoring Committee (DMC), which provides oversight for the phase-3 programme for Hematide, 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-3 trials support continuation of the studies. In the phase-3 programme, 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 M Morris, president and chief executive officer of Affymax. "We continue to make progress in enrollment of patients in the four phase-3 trials and look forward to additional DMC reviews as more data are generated."
The phase-3 programme, which consists of four trials, was initiated in October 2007. Recently, Affymax announced that enrollment is complete in Pearl 1, the first of those phase-3 trials. The company continues to enroll in the other three studies and anticipates completion of enrollment by year end 2008.
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).
Affymax and Takeda Pharmaceutical Company Limited are collaborating on the development of Hematide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda. Affymax is conducting Phase 3 clinical trials for Hematide to treat anemia associated with chronic renal failure and Takeda initiated a Phase 1 clinical trial in the U.S. to evaluate Hematide to treat chemotherapy-induced anemia in prostate, breast and non-small cell lung cancer patients.