METHOD OF MITIGATING THE ADVERSE EFFECTS OF IL-2

摘要

A new polymorphic form of (±)7-[3-(4-acetyl-3-methoxy-2-propylphenoxy)propoxy]-3,4­- dihydro-8-propyl-2H-1-benzopyran-2-carboxylic acid is disclosed. The compound has a melting point of 80°C to 82° C and is a leukotriene B4 antagonist ("LBA"). The compound is useful for diminishing the adverse effects (e.g. vascular leakage syndrome) of IL-2 treatment. Administering the compound with IL-2 diminishes the adverse effects of IL-2 and preserves or enhances the beneficial effects of LBA administration on a subject, while simultaneously mitigating the adverse effects of using a LBA. The method involves administering an amount of LBA, preferably the new polymorphic form, to a subject undergoing IL-2 treatment, where the amount administered is such that the LBA is maintained in a specified range over the treatment schedule. Also disclosed is an article of manufacture comprising a composition of the new polymorph with labeling instructions for treatment. Also disclosed is a method for preparing a pharmaceutical composition of the new polymorph and a method for preparing the polymorph itself.