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FDA Awards EGEN, Inc. Orphan - Drug Grant for Clinical Development of EGEN-001 for Treatment of Ovarian Cancer


2/2/2011 6:56:15 AM

HUNTSVILLE, Ala., Feb. 2, 2011 /PRNewswire/ -- EGEN, Inc. today announced that the Food and Drug Administration (FDA) has awarded the company a four-year grant of $1,600,000 to assist in the Phase II clinical development of EGEN-001, the company's lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer. EGEN has successfully completed two Phase I trials of EGEN-001 in ovarian cancer patients. In the first study, EGEN-001 was administered as monotherapy in platinum-resistant ovarian cancer patients and in the second study in combination with carboplatin/docetaxel chemotherapy in platinum-sensitive ovarian cancer patients. In both studies, EGEN-001 treatment resulted in good safety, biological activity and encouraging efficacy. EGEN-001 received Orphan Drug Status from the FDA in 2005 and its first orphan grant of $1,000,000 in 2005.

"This is a significant milestone and accomplishment for the company," commented Dr. Khursheed Anwer, President and CSO of EGEN. "We are pleased to receive this FDA support, which has been very useful in the advancement of our novel EGEN-001 product in the clinic for the treatment of recurrent ovarian cancer. The product utilizes the Company's proprietary TheraPlasĀ® 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 represents the fifth most common form of cancer affecting women and is the most lethal of gynecological malignancies, ranking fourth in cancer deaths among women. The death rate for this disease has not changed much in the last 50 years. 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 EGEN, Inc.

EGEN, 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. 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 synthetic carriers, their combination with DNA, and their therapeutic applications. EGEN has research pipeline products aimed at treatment of various cancer indications. In addition, the Company has its TheraSilenceĀ® delivery technology aimed at delivery of therapeutic siRNA for the treatment of human diseases. 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 EGEN intends that such forward looking statements be subject to the safe harbor created thereby. EGEN 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.

SOURCE EGEN, Inc.



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