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  • Title: Safety evaluation of recombinant human interleukin-4. II. Clinical studies.
    Author: Leach MW, Rybak ME, Rosenblum IY.
    Journal: Clin Immunol Immunopathol; 1997 Apr; 83(1):12-4. PubMed ID: 9073527.
    Abstract:
    The safety and tolerability of Escherichia coli-derived recombinant human interleukin-4 (rhuIL-4) have been evaluated in phase I and phase II studies in human patients with a variety of malignancies. Clinical trials have demonstrated that subcutaneous administration of rhuIL-4 is safe and well tolerated at doses as high as 5 micrograms/kg/day and as high as 10 micrograms/kg when administered 3 times/week. Although preclinical safety studies in cynomolgus monkeys demonstrated a number of adverse effects following repeated daily dosing with rhuIL-4, similar effects have generally not been observed in human patients.
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