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Expression Genetics, Inc. Announces Enrollment of First Patients in Phase I Clinical Trial of Gene-Based IL-12 for Treatment of Ovarian Cancer

Posted on: Monday, 17 October 2005, 12:00 CDT

HUNTSVILLE, Ala., Oct. 17 /PRNewswire/ -- Expression Genetics, Inc. announced today that a Phase I clinical study evaluating the Company's lead drug candidate, EGEN-001, is underway at The University of Alabama at Birmingham in patients with recurrent epithelial ovarian cancer. The product formulated utilizing the Company's proprietary TheraPlas(TM) 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 anti-cancer cytokine. TheraPlas(TM) 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. Plans are underway to open enrollment at a second site within a few weeks. EGEN-001 for treatment of ovarian cancer has been granted Orphan Drug Status by the FDA.

"We are pleased to see our first TheraPlas(TM) candidate meet high expectations in the preclinical studies and now reach this important clinical milestone," said Danny H. Lewis, CEO and President of Expression Genetics. "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."

Ronald Alvarez, M. D., Director, Division of Gynecologic Oncology, The University of Alabama at Birmingham, stated, "We are excited to participate in the clinical evaluation of this novel approach to treating ovarian cancer. Safe and efficacious delivery of IL-12 gene with a non-viral polymer system will be an important advancement in our treatment options for this disease. This is the first clinical use of a non-viral IL-12 gene therapy approach for treating ovarian cancer. Unlike standard chemotherapeutic agents, this cytokine is known for its ability to inhibit cancer growth by stimulating the immune system."

About Ovarian Cancer

Ovarian cancer accounts for approximately 4 percent of all women's cancers and is the fourth leading cause of cancer-related death among women in the U.S. The American Cancer Society statistics for ovarian cancer estimate that there will be 22,220 new cases and 16,210 deaths in 2005. The death rate for this disease has not changed much in the last 50 years. Ovarian cancer has the highest mortality of all cancers of the female reproductive system. This cancer is often diagnosed at an advanced stage after the cancer has spread beyond the ovary. Over $2 billion is spent in the U.S. each year on treatment of ovarian cancer.

About Expression Genetics, Inc.

Expression Genetics, Inc. (EGEN), with laboratories and headquarters in Huntsville, Alabama is a privately held biopharmaceutical company focused on developing therapeutics for the treatment of human diseases including cancer, cardiovascular disease, and infectious diseases. The Company specializes in the delivery of therapeutic nucleic acids (DNA and RNAi) and proteins aimed at specific disease targets. The Company has a significant intellectual property position in biocompatible polymers, their combination with DNA, and their therapeutic applications. EGEN has research pipeline products aimed at treatment of lung cancer, infectious diseases, and cardiovascular disease. These projects involving siRNA, shRNA, tumor antigens, and angiogenic genes are in early stages. EGEN has collaborations with outside investigators, biotech organizations, and universities on various projects in these areas.

The Company has also developed, as a secondary product line, commercial lab-scale transfection reagent kits. Arrest-In(TM), launched in 2004 by our marketing partner, Open Biosystems, Inc., provides a dual path business model for the Company with a growing revenue stream prior to market introduction of our lead therapeutic products.

Safe Harbor for Forward Looking Statements

Certain statements contained in this press release may be deemed to be forward looking statements under federal securities laws and Expression Genetics intends that such forward looking statements be subject to the safe harbor created thereby. Expression Genetics does not undertake an obligation to publicly update or revise any forward looking statements, whether as a result of new information, future events or otherwise. Actual events or results may differ from our expectations as a result of a number of factors, including but not limited to uncertainties in clinical trials and product development programs, ability and success level of the Company in securing adequate capital for operations, market place acceptance of any resulting product and other factors common to biotechnology research and development. There can be no guarantee that any product in our pipeline will be successfully developed.

Expression Genetics, Inc.

CONTACT: Bruce Hovanes, Investor and Media Relations of ExpressionGenetics, Inc., +1-256-512-0077 ext. 202

Web site: http://www.egencorp.com/

Source: PRNewswire

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