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www.fdanews.com/articles/67525-h-lee-moffitt-cancer-center-genetronics-initiate-medpulser-phase-i-clinical-trial

H. LEE MOFFITT CANCER CENTER, GENETRONICS INITIATE MEDPULSER PHASE I CLINICAL TRIAL

January 13, 2005

Genetronics Biomedical and the H. Lee Moffitt Cancer Center have initiated a Phase I clinical trial using Genetronics' MedPulser System to deliver plasmid DNA to tumors with the aim of treating malignant melanoma.

The trial is sponsored by the H. Lee Moffitt Cancer Center and will measure the safety of Genetronics' electroporation system to deliver plasmid DNA into tumor cells to mount an immune response.

In this Phase I open-label study, plasmid DNA encoding a cytokine is delivered directly to tumors in patients with malignant melanoma through electroporation using the MedPulser System. This technology enables the entry and significant uptake of plasmid DNA into the tumor cells, ultimately leading to cytokine production. The intent of this procedure is to induce an immune response that will eliminate the cancer.