Gene therapy for breast cancer in development.

2003 FEB 13 - (NewsRx.com & NewsRx.net) -- A recent article in the Houston Chronicle highlights the early successes of Introgen's (INGN) Advexin gene drug therapy in a phase II breast cancer study ongoing at The University of Texas M.D. Anderson Cancer Center.

Assistant professor in M.D. Anderson's department of breast medical oncology, Massimo Cristofanilli, and the study's principal investigator said, "We've had promising results in the 12 patients enrolled in the trial so far. All have had some sort of response. One important thing is that it's safe." The article ended with Cristofanilli noting, "This trial is proving the concept that gene therapy can enhance chemotherapy treatment."

The study profiled is a phase II clinical study to investigate the efficacy and safety of Advexin as a treatment for patients with advanced breast cancer in combination with two chemotherapeutic drugs, docetaxel (Taxotere), marketed by Aventis Pharmaceuticals (AVE) and doxorubicin (Adriamycin), marketed by Pharmacia (PHA). 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. Introgen recently announced its exclusive license to an issued U.S. patent for the combination of the p53 gene and the use of taxanes, the class of chemotherapeutics that includes Taxotere and Taxol, marketed by Bristol- Myers Squibb.

Locally advanced breast cancer accounts for 5-15% of newly diagnosed breast cancer cases in the United States and 40-60% of new cases in non-industrialized countries. 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 5 year overall survival rate of less than 20%. 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.

Advexin trial update. In other news, Introgen announced the publication of data from its phase II study combining Advexin, an adenoviral vector containing the p53 tumor-suppressor gene, with radiation therapy. The study, treating patients with non-small cell lung cancer (NSCLC), showed that approximately 60% of patients' primary tumors regressed or ...