SAFETY EVALUATION OF RECOMBINANT HUMAN INTERLEUKIN-4 .2. CLINICAL-STUDIES

The safety and tolerability of Escherichia coli-derived recombinant hu man interleukin-4 (rhuIL-4) have been evaluated in phase I and phase I I studies in human patients with a variety of malignancies. Clinical t rials have demonstrated that subcutaneous administration of rhuIL-4 is safe and well tolerated at doses as high as 5 mu g/kg/day and as high as 10 mu g/kg when administered 3 times/week. Although preclinical sa fety studies in cynomolgus monkeys demonstrated a number of adverse ef fects following repeated daily dosing with rhuIL-4, similar effects ha ve generally not been observed in human patients. (C) 1997 Academic Pr ess.