Chronic preclinical safety evaluation of Hematide, a pegylated peptidic erythropoiesis stimulating agent in monkeys.
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.
Woodburn
Kathryn W
KW
Affymax, Inc, 4001 Miranda Avenue, Palo Alto, CA 94304, USA. kathryn_woodburn@affymax.com
Wilson
Susan D
SD
Fong
Kei-Lai
KL
Schatz
Peter J
PJ
Ferrell
Thomas
T
Spainhour
Charles B
CB
Norton
Daniel
D
D000818:Animals; D004194:Disease; D004305:Dose-Response Relationship, Drug; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D004920:Erythropoiesis / Q000187:drug effects; D006397:Hematinics / Q000494:pharmacology*; D008252:Macaca fascicularis; D010455:Peptides / Q000009:adverse effects / Q000494:pharmacology*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000494:pharmacology*
D006397:Hematinics; D010455:Peptides; C514771:hematide; D011092:Polyethylene Glycols