AUSTIN, Texas and SAN ANTONIO, April 21 /PRNewswire-FirstCall/ -- 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(R) at the time of surgery for suppression of remaining tumor 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% 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. To find out if the study is being conducted in your area, contact the National Cancer Institute Cancer Information Service (CIS) at 1-800-4CANCER and reference Southwest Oncology Group Study S0011.
Introgen is a leading developer of biopharmaceutical products which use non-integrating genes to produce a therapeutic protein to treat cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial- scale, CGMP manufacturing facility.
Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which are based on current expectations and entail various risks and uncertainties. Such forward-looking statements include, but are not limited to, those relating to Introgen's future success with development of Advexin combined with surgery for head and neck cancer. There can be no assurance that Introgen will be able to commercially develop gene-based drugs, that necessary regulatory approvals will be obtained or that any clinical trials or studies undertaken will be successful or that the proposed treatments will prove to be safe and/or effective. The actual results may differ from those described in this press release due to risks and uncertainties that exist in Introgen's operations and business environment, including, but without limitation, Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, Introgen's dependence upon proprietary technology and current competition, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.
Editor's Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's Website at: http://www.introgen.com/ .
Editor's Note: For more information on the Southwest Oncology Group (SWOG), please visit http://www.swog.org/ .
Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322
Southwest Oncology Group
Dee B. Daniel
(210) 677 8808
Introgen Therapeutics, Inc.