PHASE I INOVIO TECHNOLOGY TRIAL BEGINS

Inovio Biomedical and Vical announced the initiation of a human Phase I study of an investigational method of delivering interleukin-2 (IL-2), a potent immune system stimulant, for patients with recurrent metastatic melanoma. Intravenous delivery of the protein is approved as a treatment for metastatic melanoma, but frequently causes severe systemic toxicities.

The treatment approach being studied in this trial involves direct injection into a tumor lesion of plasmid DNA encoding IL-2, followed by electroporation, the local application of electrical pulses designed to enhance the uptake of the pDNA into tumor cells. The pDNA is designed to cause cells within the tumor to produce high levels of IL-2 protein locally and stimulate the immune system to attack the tumor without the associated systemic toxicities.

Treatments will be administered once a week in two four-week cycles, with each cycle followed by a four-week observation period. The initial dose-escalation phase of the trial will enroll up to three patients each at doses of 0.5 mg, 1.5 mg and 5 mg delivered to a single tumor lesion per patient, with a final group receiving 5 mg in each of three tumor lesions per patient. Up to 17 additional patients will be treated at the highest tolerated dose.