Journal
HAEMATOLOGICA-THE HEMATOLOGY JOURNAL
Volume 93, Issue 9, Pages 1376-1379Publisher
FERRATA STORTI FOUNDATION
DOI: 10.3324/haematol.12896
Keywords
erythropoiesis; hematopoiesis; pharmacology; safety; pharmacokinetics
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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.
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