Tumor vaccine to begin clinical trials

December 05, 2003

Tampa, FL (Dec. 4, 2003) - A tumor vaccine developed at the H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida, is headed for clinical trials with advanced breast-cancer patients in collaboration with the University of Nebraska Medical Center in Omaha, Introgen Therapeutics Inc. (NASDAQ: INGN) announced today.

The research is funded by the National Institutes of Health under the National Cancer Institute's Avon program.

The vaccine therapy, INGN 225, which has already been tested on small populations of lung-cancer patients, will be evaluated in a phase I/II study to treat patients with advanced breast cancer. An estimated 267,000 new cases of invasive and in situ breast cancer are expected to occur among women in the United States during 2003, resulting in an estimated 39,800 deaths.

"A goal of cancer immunologists is the development of viable cancer vaccines. As we progress into human trials for different types of cancer, we are moving closer to achieving that goal," said Dmitry Gabrilovich, M.D., Ph.D., one of the vaccine's developers at Moffitt and the USF College of Medicine.

Gabrilovich, an associate professor in Departments of Interdisciplinary Oncology and Molecular Biology and Biochemistry, further explained, "With the high incidence and mortality rates of breast cancer, we are eager to evaluate INGN 225 therapy in cancer patients with this devastating disease. We are excited because this vaccine approach may be applicable to many different kinds of cancer, not just lung and breast."

Moffitt researchers will prepare the vaccine and participate in immunologic evaluations. The trial with breast-cancer patients will be conducted at the University of Nebraska Medical Center. Enrollment will begin with patients with invasive breast cancer who will receive chemotherapy, in addition to the INGN 225 vaccine.

INGN 225 uses Introgen's Advexin drug to stimulate the patient's dendritic cells, which are then used as a therapeutic vaccine to immunize a patient against their cancer. Previously published preclinical data from Dr. Gabrilovich's group demonstrated that 60 percent of animals treated with INGN 225 were protected against tumor development. When dendritic cells were activated, 100 percent protection against tumors was achieved.

INGN 225 is already being evaluated in patients with small-cell lung cancer, also in a phase I/II study. This phase I/II study is funded by a grant from the American Cancer Society.

In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in the U.S. News & World Report as one of the top cancer hospitals in America.

University of South Florida (USF Health)

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