Introgen Therapeutics, Inc. and the Southwest Oncology Group (SWOG), one of the largest US cancer clinical trials cooperative groups, have entered into an agreement to conduct a Phase II study with Introgen's Advexin cancer therapy. This study will target Stage III or IV squamous cell carcinoma of the oral cavity and oropharynx that can be surgically removed. Approximately 60 head and neck cancer patients will undergo surgery and receive Advexin intraoperatively and postoperatively, and afterwards will receive a combination of chemotherapy and radiotherapy.
"We previously demonstrated and published that Advexin can be administered safely at the time of surgery. We are delighted that the SWOG has chosen to sponsor and expand these studies in patients with operable head and neck cancers to a Phase II study," said Dr Robert E Sobol, Introgen's senior vice president for medical and scientific affairs. "This affords Introgen access to some of the country's premier surgical specialists in this disease and complements our ongoing pivotal Phase III studies in advanced recurrent disease."
Approximately 60 patients will be enrolled in this study that is being conducted at 10 sites across the United States where specific surgeons have been designated to perform the surgery.
Dr Charles A Coltman, Jr., chairman of the Southwest Oncology Group said, "The Southwest Oncology Group is dedicated to understanding and successfully treating cancer. This agreement with Introgen is an example of our commitment to the pursuit of novel approaches to cancer treatment and meeting our mission to improve the lives of people with cancer."
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. Cancers of the oropharynx occur in approximately 4,000 patients annually in the United States. Frequently, cancers in this region of the body recur after surgery, chemotherapy, and radiotherapy, and consequently new approaches to preventing recurrence are needed. Surgery is the most common form of treatment used in approximately 780,000 cancer cases in the United States annually.