Affymax Begins Phase II Trial of Hematide for Treatment of Anemia

Affymax has announced it has initiated a Phase II trial of its lead investigational product Hematide, a synthetic, peptide-based erythropoiesis stimulating agent, which is being developed to stimulate production of red blood cells for the treatment of anemia in patients with chronic kidney disease (CKD) and cancer. The randomized, double-blind, placebo-controlled, sequential dose escalation study will evaluate the safety, pharmacodynamics and pharmacokinetics of a single intravenous injection of Hematide in patients with CKD who are not on dialysis and have not had prior ESA treatment.

Previously announced results from the Phase I dose-finding trial demonstrated that single doses of Hematide resulted in dose dependent increases in circulating reticulocytes in healthy volunteers. At the highest dose tested, Hematide also achieved a clinically and statistically significant increase in hemoglobin from baseline that was sustained for at least a month. Increases in hemoglobin and reticulocytes are indications of red blood cell production.