Journal
DRUG AND CHEMICAL TOXICOLOGY
Volume 31, Issue 2, Pages 229-244Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/01480540701873186
Keywords
erythropoiesis stimulating agents; anemia; pharmacology; safety; toxicology
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The pharmacology, toxicokinetics, and safety of Hematide (TM) a synthetic peptidic erythropoiesis-stimulating agent (ESA), were characterized. Hematide was given intravenously (0, 0.5, 5, and 50 mg/kg) weekly for five weeks with a 6- (rat) and 12-week (monkey) recovery period. The pharmacological action of Hematide resulted in polycythemia. Histopathology consistent with drug-induced exaggerated pharmacology was observed primarily in rats. Secondary sequelae resulting from pronounced polycythemia was considered the cause of deaths in rats and a single high-dose monkey. Toxicokinetic analysis indicated prolonged exposure. In conclusion, Hematide is a potent ESA and the safety and efficacy profile support clinical development.
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