Abstract

5541 Background: EGEN-001 is an immunotherapeutic agent that comprises a human IL-12 plasmid that encodes for functional IL-12 and a synthetic DNA delivery system polyethyleneglycol-polyethyleneimine-cholesterol that facilitates plasmid delivery into cells. Ip injection of EGEN-001 is associated with increases in IL-12 levels and its downstream cytokines in the tumor environment without a significant increase in systemic circulation. The study’s purpose was to assess safety and efficacy of escalating doses of EGEN-001 with pegylated liposomal doxorubicin (PLD) in recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC) patients. Methods: Patient eligibility criteria: Females age ≥ 18 years with persistent or recurrent EOC. Patients were not required to have measurable disease and could have a biochemical recurrence; must have had one prior platinum-based chemotherapeutic regimen and up to two additional cytotoxic regimens; have adequate organ function. The trial was a ...

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