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Chronic preclinical safety evaluation of Hematide^TM, a pegylated peptidic erythropoiesis stimulating agent in monkeys

¹ Affymax, Inc., Palo Alto, CA
² Aclairo Pharmaceutical Development Group, Inc, Vienna, VA
³ Pennsylvania Biolab Inc., Radnor, PA
⁴ Calvert Laboratories, Olyphant, PA, USA

Correspondence: Kathryn W. Woodburn, PhD, Affymax, Inc, 4001 Miranda Avenue, Palo Alto, CA, 94304 USA. E-mail:kathryn_woodburn{at}affymax.com

ABSTRACT

Hematide is a synthetic peptide-based, pegylated erythropoiesis stimulating agent in clinical development for treatment of anemia. To support chronic clinical dosing requirements, a 9-month repeat dose IV monkey safety study was undertaken. Animals received 0, 0.2, 2 or 20 mg/kg hematide IV every three weeks for nine months followed by a 14-week recovery. Hematide administration was associated with time and dose-dependent polycythemia. Histological findings were related to exaggerated pharmacology that was secondary to the administration of an erythropoiesis stimulating agent to a normocythemic animal. In conclusion, these results support the use of repeated administration of hematide for the correction of anemia.

Key words: erythropoiesis, hematopoiesis, pharmacology, safety, pharmacokinetics.