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EGEN, Inc. Announces a Phase I Clinical Trial for Advanced Ovarian Cancer


3/20/2013 9:07:57 AM

HUNTSVILLE, Ala., March 19, 2013 /PRNewswire/ -- EGEN, Inc. today announced that it has recently initiated a Phase I clinical trial of its novel immunotherapy agent, EGEN-001, in combination with PEGylated liposomal Doxorubicin or Lipodox for the treatment of recurrent ovarian cancer. The EGEN-sponsored trial is conducted by a network of researchers led by Gynecologic Oncology Group (GOG) at member institutions under an agreement between the GOG and EGEN, Inc. Dr. Premal Thaker, of Washington University School of Medicine, is the Study Chair for the trial.

"We are pleased to have this trial begin as it advances the testing of our novel EGEN-001 product with an approved second-line treatment for platinum-resistant ovarian cancer," commented Dr. Khursheed Anwer, President and CSO of EGEN. "Long-term treatment with an immune modulating agent in conjunction with cytotoxic agents is a promising approach to combatting difficult to treat cancers." The product utilizes the Company's proprietary TheraPlas® 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. EGEN-001 product is currently being examined as a single agent in a Phase II clinical trial for the treatment of platinum-resistant ovarian cancer and in combination with chemotherapeutic agents following cytoreductive surgery and HIPEC therapy in colorectal cancer.

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 the Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG) is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. The GOG is one of the National Cancer Institute's funded cooperative groups. The GOG is the only group that focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix. The GOG is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, basic scientists, quality of life experts, data managers, and administrative personnel.

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 especially cancer. The Company specializes in the delivery of therapeutic nucleic acids (DNA and RNAi) aimed at specific disease targets. The Company has a significant intellectual property position in synthetic carriers, their combination with DNA, expression vectors and their therapeutic applications. EGEN has research pipeline products aimed at treatment of various cancer indications. In addition, the Company has its TheraSilence® 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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