Abstract
Results of our basic research for the development of gene therapy by means of cationic liposomes were reviewed. In vitro and in vivo studies have revealed that repeated exposure of melanoma cells to the liposomes containing interferon-β gene increased the number of transfected cells with the gene and induced substantial expression of IFN-β. In the system of B6 mice/16 mouse melanoma, growth of melanoma nodules was significantly suppressed with a single injection of IFN-β gene (3μg DNA). Moreover, human melanoma nodules transplanted to the nude mice completely regressed after 6 times of injection of the liposomes containing IFN-β gene (3μg DNA). Immunohistochemical investigation revealed degenerative changes of melanoma cells corresponding to apoptosis. These data give a solid base for the clinical application of this gene therapy to malignant melanoma. The protocol of the clinical trial was evaluated and has been approved by the Working Committee of the Ministry of Health, Labour, and Welfare. The phase I/II clinical study will soon start. [Skin Cancer (Japan) 2004; 19: 41-47]
