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¹ Department of Surgery and Science, Graduate School of Medical Sciences and ² Department of Immunology, Medical Institute of Bioregulation, Kyushu University, Fukuoka, Japan and ³ Division of Stem Cell Regulation Research, Osaka University Graduate School of Medicine, Osaka, Japan

Requests for reprints: Yo-ichi Yamashita, Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. Phone: 81-92-642-5469; Fax: 81-92-642-5482. E-mail: harimoto{at}surg2.med.kyushu-u.ac.jp

We developed a new potent nonviral gene transfer method into mouse muscles in vivo named "electrosonoporation." We tried in this report to treat murine orthotopic hepatocellular carcinoma (HCC) by muscle-targeted mouse interleukin-12 (mIL-12) gene transfer using in vivo electrosonoporation. I.m. administration of the mIL-12 gene with electrosonoporation elevated serum IL-12 and IFN- and significantly prolonged the survival periods with both growth inhibition of orthotopic HCC and inhibition of spontaneous lung metastasis. The IL-12 gene therapy reduced the number of microvessels and induced more Mac-1-positive cells into HCC. These results show that muscle-targeted mIL-12 gene therapy for orthotopic HCC using in vivo electrosonoporation is very efficient and is thus promising for further clinical trial.

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Received 3/18/04; revised 6/ 8/04; accepted 6/30/04.