CLINICAL-PATHOLOGICAL ALTERATIONS ASSOCIATED WITH SUBCUTANEOUS ADMINISTRATION OF RECOMBINANT HUMAN INTERLEUKIN-4 TO CYNOMOLGUS MONKEYS

Recombinant human interleukin 4 (rhuIL-4) is a candidate for the treat ment of refractory cancer based on its potential to enhance immune fun ction. Recombinant human IL-4 was administered subcutaneously at 0, 1, 5, or 25 mug/kg/day for 28 days with a 14-day recovery to male and fe male cynomolgus monkeys as . part of the preclinical safety evaluation . Clinical pathologic changes related to treatment with rhuIL-4 were e vidence of consumptive coagulopathy, erythrocyte fragmentation, lympho cytosis, and lymphocyte morphologic changes indicative of marked antig enic or mitogenic stimulation, mild eosinophilia and neutrophilia, hyp oalbuminemia, hypocholesterolemia, and hypertriglyceridemia. Based on data obtained after the 14-day recovery period, the clinical pathologi c changes associated with rhuIL-4 administration were considered to be reversible.