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news.A phase I clinical study evaluating the Expression Genetics lead drug candidate, EGEN-001, is underway at The University of Alabama in patients with recurrent epithelial ovarian cancer.
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The product formulated utilizing the company’s proprietary TheraPlas delivery technology is composed of interleukin-12 (IL-12) gene expression plasmid and a biocompatible delivery polymer and is designed to increase the local concentration of IL-12, a potent anticancer cytokine.
TheraPlas is a novel polymeric- based system for delivery of nucleic acids to cells. Up to 18 patients will be enrolled in the open label, dose escalation study with safety as the primary endpoint.
EGEN-001 for treatment of ovarian cancer has been granted orphan drug status by the FDA.
“Our goal is to provide patients and caregivers with another potent weapon against ovarian cancer and through continued testing ultimately use EGEN-001 to treat several different forms of cancer including pancreatic, colorectal, brain, and head & neck,” said Danny Lewis, CEO and president of Expression Genetics.