said Monday it plans to initiate phase III clinical studies for anemia treatment Hematide in patients with chronic renal failure.
The biopharmaceutical company said it expects to begin a 12-month enrollment process later this year for the phase III program, which will include 2,200 chronic renal failure patients and four open-label controlled clinical trials.
Two of the studies will evaluate the drug's safety and efficacy compared to
anemia treatment, darbepoetin alfa, in non-dialysis patients. The other trials will evaluate its safety, efficacy and ability to maintain hemoglobin levels in dialysis patients previously treated with Erythropoietins, or EPO, compared to anemia treatments epoetin alpha and epoetin beta when patients switch from those treatments to Hematide.
The primary efficacy endpoint will be the mean change in hemoglobin, the iron-containing protein carried in red blood cells, from baseline.
Affymax rose $2.29, or 8.9%, to $29.30 Monday morning.