Press Release: Expression Genetics Receives Orphan Drug Grant from FDA
Expression Genetics Receives Orphan Drug Grant from FDA for Clinical Development of EGEN-001 for Treatment of Ovarian Cancer HUNTSVILLE, Ala., May 2 -- Expression Genetics, Inc. today announced that the Food and Drug Administration (FDA) has awarded the company a three-year grant of $1,050,000 to assist in the clinical development of EGEN-001, the company's lead product. EGEN-001 is under development for the treatment of advanced recurrent ovarian cancer. The product has recently completed a Phase I trial and is advancing toward expanded clinical testing to evaluate safety and efficacy of the drug when administered in combination with standard chemotherapy treatment. EGEN-001 received Orphan Drug Status from the FDA in 2005. "This is a significant milestone and accomplishment for the company," commented Dr. Danny H. Lewis, CEO of Expression Genetics. "We are very pleased to receive this support from the FDA and it represents a nice validation of our efforts and technology in this field of research. This grant will provide additional funding to expedite the overall clinical program and enable us to continue development of this promising technology which may offer physicians a better option in the treatment of this serious disease." Dr. Khursheed Anwer, principal investigator and vice president of research and development added, "the product utilizes the Company's proprietary TheraPlas(R) delivery technology and is composed of interleukin-12 (IL-12) gene formulated with a biocompatible delivery polymer. IL-12 is a potent cytokine which works by enhancing the body's immune system against cancer and inhibiting tumor blood supply." About Ovarian Cancer Ovarian cancer accounts for approximately 4 percent of all women's cancers and is the fifth 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 22,430 new cases and 15,280 deaths in 2007. The death rate for this disease has not changed much in the last 50 years. Ovarian cancer is often only diagnosed at an advanced stage, after the cancer has spread beyond the ovary and has the highest mortality of all cancers of the female reproductive system. 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 and cardiovascular disease. 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 various cancers 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. 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.