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Advexin Undergoing Fast Track Review by FDA

AUSTIN, Texas, Sept. 17 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (NASDAQ:INGN) announced today that its investigational cancer therapy, Advexin, was granted designation as a Fast Track Drug Product development program by the U.S. Food and Drug Administration (FDA) for its effect on prolonging survival and on prolonging the time to loco-regional disease progression in patients with recurrent, unresectable squamous cell carcinoma of the head and neck. Each year approximately 40,000 Americans are affected with head and neck cancer.

By designating Advexin as a Fast Track product, the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of Advexin. FDA may also evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions. The FDA previously granted Advexin orphan drug status in head and neck cancer.

"We are extremely pleased by today's news since it confirms Advexin's potential to treat a devastating disease for which there is no approved biologic or drug treatment. It also reflects the FDA's leadership in the war on cancer by providing biotechnology and pharmaceutical sponsors with assistance in accelerating the development and approval of essential therapies," said Dr. Max Talbott, Introgen's senior vice president of worldwide commercial development.

Introgen currently has two ongoing phase 3 studies of Advexin in head and neck cancer. In one study the effect on survival time (primary endpoint) of Advexin mono-therapy is compared to that of methotrexate. Secondary endpoints are objective response rate, time to progression and tumor growth control. In the second study, a combination of Advexin with platinum and 5-fluorouracil is compared to that of the combined chemotherapies. The primary endpoint in this study is time to progression. Secondary endpoints include survival time, objective response rate and tumor growth control.

Two Advexin phase 2 studies have been completed in which patients with recurrent head and neck cancer received injections of Advexin at two dose levels into local and regional disease. In these studies, patients receiving a higher dose, consistent with the dose used in Introgen's phase 3 studies, experienced an 88 percent improvement in median survival time compared to historical controls, as well as an increased survival compared to patients receiving the lower dose of Advexin. Additionally, 73 percent of the tumors that were injected with Advexin stopped growing or diminished in size.

Clinical responses were observed in patients whose tumors were resistant to previous chemotherapy. Both phase 2 studies were conducted using Advexin alone, as a mono-therapy. The most common adverse events in both studies were fever without infection, pain on injection, and nausea. There were no significant bone marrow, liver or kidney toxicities observed in patients in either study.

In addition to demonstrating the potential to treat head and neck cancer, Advexin has shown indication of effectiveness in other cancers. Data published in the January 2003 issue of the journal Clinical Cancer Research of a phase 2 study of patients with non-small cell lung cancer treated with Advexin and radiotherapy showed over 60 percent of patients' primary tumors regressed or disappeared after the combination therapy, as assessed by both biopsies and by CT scans three months after treatment. Additionally, Advexin administration did not appear to increase the side effects caused by radiation treatment. Preliminary data from a phase 2 study in patients with locally advanced breast cancer indicated that Advexin can be safely combined with two standard chemotherapies, Taxotere(R), marketed by Aventis, and Adriamycin(R), marketed by Pfizer (Pharmacia). Interim evaluation demonstrated that ninety percent of the patients in the study had complete or partial (greater than 50 percent) responses in treated lesions. Pathological examination revealed only scattered residual tumor cells. No patients had progressive disease. These data were published at the 39th annual meeting of the American Society of Clinical Oncology.

About Advexin
Advexin supplies p53 protein in very high concentrations in cancer tissue and selectively kills cancer cells while not harming the surrounding normal cells. p53 is a normal constituent of cells and is known as a tumor suppressor because it provides a powerful halt signal on cell growth. One of the major roles of this protein is to recognize when the cell has been damaged by mutation and stop cell growth to initiate repair. If the cell is damaged beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control.

About Head and Neck Cancer

Cancer of the head and neck is a progressively debilitating and life- threatening disease. Approximately 40,000 cases of head and neck cancer occur annually in the United States, according to the American Cancer Society. Despite significant advances in other areas of cancer therapy, therapies for patients diagnosed with head and neck cancer have not improved and chances of survival remain dismal. Head and neck cancer patients whose cancer returns after initial treatment will likely die within six to 12 months. Although surgery and radiation therapy are the standard treatment regimens for primary disease, no FDA approved biologic or pharmaceutical treatments exist for patients with recurrent head and neck cancer. Experimental chemotherapy regimens in use for recurrent disease have not demonstrated an improvement in survival.

Source: Introgen Therapeutics, Inc.

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