Introgen Therapeutics Inc has treated several breast cancer patients with Advexin in a phase 2 trial. The results of this study, together with the ongoing phase 3 studies of Advexin in head and neck cancer patients, may broaden the spectrum of diseases that can be effectively treated with this novel approach.

The new clinical study will investigate the efficacy and safety of Advexin as a treatment for patients with advanced breast cancer in combination with two chemotherapeutic drugs, docetaxel and doxorubicin. In addition, the study will evaluate the growth of new blood vessels in breast cancer tumors, known as angiogenesis, and how it relates to cell death in the tumors.

"We expect Advexin to become an important and versatile weapon in the fight against cancer," said Keith Coffee, Introgen's director of clinical sciences. "Because it is extremely well tolerated, Advexin can be combined with a number of currently available treatments. By selectively killing cancer cells while leaving normal cells unharmed, we hope to learn if Advexin can effectively be coupled with surgery and chemotherapy. In this trial, Advexin is being used to treat women diagnosed with locally advanced breast cancer, the more advanced form of primary breast cancer. If this treatment regimen is safe and shows clinical activity, it may be applied to earlier stages of disease, particularly for cancer patients who are candidates for treatments prior to surgery."

Advexin, is already the subject of two randomized and controlled phase 3 clinical trials for treating patients with advanced head and neck cancer and a phase 2 study combined with radiotherapy for the treatment of patients with non-small cell lung cancer.

Locally advanced breast cancer accounts for 5 to 15 per cent of newly diagnosed breast cancer cases in the United States and 40 to 60 per cent of new cases in non-industrialized countries, according to Dr. Cristofanilli. An estimated 203,500 new invasive cases of breast cancer are expected to occur among women in the United States this year, in addition to 54,300 new cases of in situ breast cancer, according to the American Cancer Society. Breast cancer patients have a poor prognosis when treated by surgery and/or radiotherapy, with a five year overall survival rate of less than 20 per cent. In the past 15 years, the management of locally advanced breast cancer has changed, and chemotherapy is presently an integral part of the multi-modality approach in this disease.