Phase III for Affymax's ESA Hematide to finish by year-end
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Phase III trials of Affymax/Takeda's erythropoiesis-stimulating agent Hematide will wrap-up by year-end, Affymax announced Sept. 9. The 400 clinical trial sites will complete treatment of patients by the end of 2009, a timeline allowed due to the firms securing of $42 million in private and public financing in February (1"The Pink Sheet" DAILY, Feb. 17, 2009). The Phase III program includes 2,600 chronic renal failure patients enrolled in four open-label non-inferiority trials. Two of the trials are in patients on dialysis, and are evaluating Hematide's ability to maintain hemoglobin levels in the target range when patients are switched from epoetin alfa or epoetin beta. The other two trials are in patients not on dialysis, and are comparing Hematide to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time. The controversy over safety problems with ESAs for chemotherapy-induced anemia caused the firms to suspend development last year of Hematide for that population (2"The Pink Sheet" DAILY, Aug. 29, 2008). The companies expect to report top-line results and file the NDA in 2010