Liposome-mediated gene transfer offers the potential to introduce DNA encoding therapeutic DNA to treat human disease. Several genes have been used in gene therapy to stimulate immune response in malignancy, and allogeneic major histocompatibility complex (MHC) proteins also serve as a potent stimulus to the immune system. This study was performed to determine the transfection efficiency and safety of liposome- mediated gene delivery into human cancer cell lines and animals. Placental alkaline phosphatase gene as a reporter was transfected into PCI-13 and NCI-H522 cell lines, and the expression was determined in individual transfected cells by histochemical staining. The transfectian efficiency was the highest at 24 ¥ig of DNA mixed with 10¥il of lipofectamine in vitro, HLA-B7 DNA as a therapeutic gene was transfected into cell lines and injected subcutaneously into the rabbits. The HLA-B7 gene expression was successfully identified by RT-PCR in vivo and in vitro. Twenty percents of the cells expressed HLA-B7 proteins which were analyzed by flow cytometry. In rabbit model, no pyrogenic response was ob- served after subcutaneous injection of HLA-B7/liposome complexes. The expression of injected HLA-B7 gene was restricted within the injected skin. These data showed the feasibility and safety of liposome-mediated gene transfer. These findings will provide a basis to develop strategies for the gene therapy of human cancer.