ABSTRACT

Description: Denileukin diftitox is an engineered recombinant protein produced in Escherichia coli using recombinant DNA technology. It consists of a modified form of diphtheria toxin fused to human interleukin 2 (IL-2). Specifically, this 58-kDa protein consists of a portion of diphtheria toxin fragments A and B from Corynebacterium diphtheriae strain C7 fused to human IL-2. The amino acid sequence consists of an N-terminal methionine residue, amino acids 1-386 and 484-485 from the diphtheria toxin, and amino acids 2-133 of IL-2. The eukaryotic binding site of the diphtheria toxin has been deleted in the fusion protein, but the cytotoxic and the translocation domains of the toxin are retained. It is provided as a frozen solution (150 µg/ml active ingredient) to be administered intravenously.