HUNTSVILLE, Ala., July 20 /PRNewswire/ -- Expression Genetics, Inc., announced today that a Phase Ia clinical study evaluating the Company's lead drug candidate, EGEN-001, in combination with standard chemotherapy is underway at The University of Alabama at Birmingham for patients with recurrent epithelial ovarian cancer. The product formulated utilizing the Company's proprietary TheraPlas(R) delivery technology is composed of interleukin-12 (IL-12) gene expression plasmid and a bio-compatible delivery polymer and is designed to increase the local concentration of IL-12, a potent anti-cancer cytokine. TheraPlas(R) is a novel polymeric- based system for delivery of nucleic acids to cells. Up to 30 patients will be enrolled in the open label, dose escalation study with safety as the primary endpoint. Plans are underway to open enrollment at additional sites within a few weeks.
A Phase I trial evaluating safety of EGEN-001 monotherapy in treatment of ovarian cancer patients was completed in 2006. EGEN-001 for treatment of ovarian cancer has been granted Orphan Drug Status and Orphan Drug Funding by the FDA. Dr. Danny H. Lewis, President and CEO of Expression Genetics stated, "We are excited to see EGEN-001 advance to this important next level of clinical testing. Results of the earlier Phase I trial with EGEN-001 as a monotherapy were highly encouraging showing us that EGEN-001 could be administered safely and result in biological activity. This outcome has provided a solid justification for moving this TheraPlas(R) candidate further along the clinical development pathway. The safety and efficacy of EGEN-001 in combination with chemotherapy has been demonstrated in animal models for ovarian cancer."
Ronald Alvarez, M. D., Director, Division of Gynecologic Oncology, The University of Alabama at Birmingham, stated, "We are pleased to continue our participation in the clinical evaluation of this novel approach to treating ovarian cancer. We currently have enrolled the first cohort in the trial and preliminary results on safety and tolerability at this dose level indicate that EGEN-001 can be administered in combination with carboplatin/docetaxel therapy. Safe and efficacious delivery of IL-12 gene with a non-viral delivery system will be an important advancement and will expand our treatment options for this disease. Epithelial ovarian cancer is the deadliest and most commonly diagnosed form of the disease."
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.
Expression Genetics, Inc.CONTACT: Bruce Hovanes, Expression Genetics, Inc., +1-256-512-0077 ext.202
Web site: http://www.egencorp.com//
