The Southwest Oncology Group (SWOG), one of the largest U.S. cancer clinical trials cooperative groups supported by the National Cancer Institute, has initiated a new clinical trial using gene therapy for the treatment of Stage III or IV squamous cell carcinoma (SCC) of the oral cavity, or oropharynx, that is able to be removed surgically.

The study is designed to assess the feasibility, efficacy and safety of administering Advexin at the time of surgery for suppression of remaining tumour cells, followed by a combination of chemotherapy and radiation therapy. Advexin is a product of Introgen Therapeutics, Inc.

"One of the problems with head and neck cancer is that 25-40 per cent of patients will relapse after conventional therapy," states Dr. George Yoo, associate professor at Wayne State University and the Barbara Ann Karmanos Cancer Institute in Detroit and principal investigator for the study. "We hope that the administration of Advexin at the time of surgery will kill residual cancer cells and improve patients' ultimate outcome with no additional toxicity."

Squamous cell carcinomas are the most prevalent cancers of the oral cavity region, and it is estimated that 30,000 new cases of oral cavity cancer occur annually in the United States. Cancers of the oropharynx occur in approximately an additional 4,000 patients annually.

Frequently, cancers in this region of the body recur after surgery, chemotherapy, and radiotherapy, and consequently new approaches to preventing recurrence are needed. Advexin may provide an alternative mechanism for controlling the residual disease with limited or no added toxicity, which may translate to less frequent recurrence, prolonged survival, or improvements in the quality of life.

Dr. Charles A. Coltman, Jr., chairman of the Southwest Oncology Group said, "The Southwest Oncology Group is dedicated to understanding and successfully preventing and treating cancer. This study is another example of our continuing commitment to aggressively pursue new approaches of treatment and improve the lives of people with cancer."

The study will be conducted at 10 sites across the United States and will enroll approximately 60 patients.