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Efficient Therapeutic Gene Delivery after Systemic Administration of a Novel Polyethylenimine/DNA Vector in an Orthotopic Bladder Cancer Model¹

Departments of Urology [P. S., T. K., C. P. N. D.] and Genitourinary Medical Oncology [H. I., S. W., M. Y., W. F. B., R. J. C.], The University of Texas, M. D. Anderson Cancer Center, Houston, Texas 77030

Successful systemic gene therapy has been hindered by vector-related limitations, including toxicity and inefficient gene delivery to tumor cells after i.v. administration. To circumvent these problems, we developed a novel formulation between the polycation polyethyleneimine and DNA that mediates high-level tumor cell transduction in vitro and efficient i.v. gene delivery in that greater reporter gene expression occurred in tumor than in lung. Strikingly, administration of just 6 µg of the polyethyleneimine/DNA-p53 vector every 3 days for 3 weeks indicated restoration of normal cell cycle regulation and apoptotic mechanisms as demonstrated by efficient p53 expression, increased apoptosis, and a 70% reduction in tumor size in an orthotopic bladder cancer model. This novel vector formulation represents a new method to increase i.v. delivery of genes to tumors.

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				L. C. Pagliaro In Reply: J. Clin. Oncol., March 15, 2004; 22(6): 1163 - 1164. [Full Text] [PDF]