Development of gene therapy for malignant melanoma with transfection of human IFN-β gene

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The purpose of this project is to develop a new gene therapy for patients with advanced malignant melanoma, which is highly resistant to any conventional therapies. In our previous study, we found that malignant melanoma transfected with interferon-β( IFN-β ) gene by means of cationic multilamellar liposomes expressed the gene and secreted IFN-β. Moreover, human melanoma nodules transplanted to nude mice were eradicated completely with 6 times injection of IFN-β gene ( 3ug DNA/time ). This year, we have investigated mechanisms of effect of this gene therapy. We have found transfection of IFN-β gene induces apoptosis of melanoma cells. In addition, in experiments in the murine B16 melanoma system, we have found NK cells play an important role in the growth inhibition ofmelanoma nodules in C57BL/6 mice. Furthermore, we have confirmed repeated treatment with the cationic liposome containing IFN-β gene increases tranfection efficiency of the gene.Based on the data obtained in studies in this year along with those performed in the previous 2 years, we consider we have almost completely finished preparation for the clinical study. We have now applied clinical trial of this gene therapy to the committees of our medical school in order to start the clinical study of the gene therapy for patients with advanced melanoma.