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Expression Genetics, Inc. Announces Successful Completion of Phase,I Trial of Gene-Based IL-12 for Treatment of Ovarian Cancer

HUNTSVILLE, Ala., April 16, 2007 /PRNewswire/ -- Expression Genetics, Inc., announced today the completion of a Phase I clinical study evaluating the Company's lead drug candidate, EGEN-001. The study, conducted at The University of Alabama at Birmingham and , evaluated the safety, tolerance, preliminary efficacy, and biological activity of the EGEN-001 in 13 patients with advanced recurrent epithelial ovarian cancer. The product, utilizing the Company's proprietary TheraPlas(R) delivery technology, is composed of interleukin-12 (IL-12) gene expression plasmid formulated with a biocompatible delivery polymer and is designed to increase local concentration of IL-12 protein. IL-12 is a potent anti-cancer cytokine which works by enhancing the body's immune system against cancer and inhibiting tumor blood supply. EGEN-001 for treatment of ovarian cancer has been granted Orphan Drug Status by the FDA.

The Phase I clinical trial was an open-label dose escalation study involving four dose levels of EGEN-001 administered intraperitoneally by four weekly infusions in chemotherapy-resistant advanced stage recurrent ovarian cancer patients. The treatment was well tolerated with no apparent dose- related trends in clinical laboratory, ECG, or vital sign parameters. General observations included abdominal cramping, mild to moderate peritonitis, nausea, and mild elevation of body temperature. These data demonstrate that this IL-12 gene therapeutic is safe for intraperitoneal administration in ovarian cancer patients.

Several clinical and biological parameters were evaluated as secondary endpoints of this study. Tumor burden of patients was monitored during treatment and results show 31% of patients showed stable disease. To date, the overall median survival is over 12.2 months with 7 out of 13 patients still surviving. There appeared to be some trend with respect to clinical benefit in the patients treated with
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