Introgen Therapeutics, Inc. announced that its vaccine therapy, INGN 225, would be evaluated at two US cancer centers 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.

Drs Kenneth H Cowan and Elizabeth Reed at the University of Nebraska Medical Center in Omaha, Nebraska will conduct the trial. The H Lee Moffitt Cancer Center in Tampa, Florida will prepare the vaccine and participate in immunologic evaluations. Enrollment will begin with patients with invasive breast cancer who will receive chemotherapy, in addition to the INGN 225 vaccine. The INGN 225 vaccine was developed based on work by Dr Dmitry Gabrilovich, associate professor of Oncology at the Moffitt Cancer Center and Dr David Carbone, professor of oncology at The Vanderbilt-Ingram Cancer Center and is exclusively licensed to Introgen Therapeutics.

Dr Gabrilovich said, "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. 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."

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 pre-clinical data from Dr Gabrilovich's group demonstrated that 60 per cent of animals treated with INGN 225 were protected against tumour development. When dendritic cells were activated, 100 per cent protection against tumours was achieved. INGN 225 is already being evaluated in patients with small-cell lung cancer, also in a phase I/II study.

Advexin therapy, recently designated as a Fast Track programme for head and neck cancer by the FDA, has been evaluated in numerous clinical studies including phase 3 studies for head and neck cancer, as well as phase 1 and 2 studies for various types of cancer. In these studies, Advexin uses the p53 protector gene ("guardian of the genome") to directly kill cancer cells and to stop tumour growth, without harming normal cells.