Public Release:  New therapeutic treatment approach improves survival in esophageal cancer patients

American College of Gastroenterology

Orlando, FL, October 6, 2008 - A study released at the 73rd Annual Scientific Meeting of the American College of Gastroenterology in Orlando found that a new therapeutic treatment, when delivered endoscopically and used in combination with chemotherapy and radiation therapy, improved survival rates in patients with locally advanced esophageal cancer. Cancer of the esophagus often has a poor survival rate.

Dr. Kenneth Chang of University of California Irvine Medical Center and his colleagues conducted a Phase 2 multi-center study on the safety and long-term efficacy of a new biologic therapy (TNFeradeTM), an injection of an anti-tumor agent, in 24 patients with locally advanced esophageal cancer.

Patients received standard care chemotherapy and radiation. In addition, the patients received TNFeradeTM through a standard endoscope or endoscopic ultrasound that guided the injection directly into the esophageal tumor. TNFeradeTM contains a non-replicating virus, which has been engineered to deliver the gene for a cancer fighting protein, TNF-alpha and works synergistically with chemoradiation representing a "triple threat" to cancer cells.

TNFeradeTM was administered once a week for a total of 5 treatments. Surgery was performed 5-11 weeks after completion of therapy. Researchers monitored the effects of this combined therapy by observing the side effects, tumor response, and overall survival.

Researchers found most tumors were of the "adenocarcinoma" type. These tumors were locally advanced (had gone through the deeper layers of the esophagus and/or had spread to lymph nodes) but still potential candidates for surgery.

TNFeradeTM in combination with chemoradiation in this group of patients, resulted in a median survival of 48.4 months, in contrast to previously published trials showing a median survival of 9.7 to 34 months. At one particular dose all four of the patients were alive without any recurrence at 48 months. Three of these patients had tumor resections, which showed no residual cancer cells in the surgical specimens.

According to lead investigator Dr. Chang, "This new treatment, in combination with chemoradiation in this group of patients, represents an encouraging increase in survival relative to historical controls and therefore warrants additional evaluation. TNFeradeTM is a promising treatment that represents a new paradigm in esophageal cancer treatment, with the gastroenterologist administering the local anti-tumor agent through a scope."

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About the American College of Gastroenterology

Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 10,000 individuals from 80 countries. The College is committed to serving the clinically oriented digestive disease specialist through its emphasis on scholarly practice, teaching and research. The mission of the College is to serve the evolving needs of physicians in the delivery of high quality, scientifically sound, humanistic, ethical, and cost-effective health care to gastroenterology patients.

The ACG is committed to providing accurate, unbiased and up-to-date health information. Visit the ACG Web site www.acg.gi.org to access educational resources for patients and their families spanning the broad range of digestive diseases and conditions - both common and not-so-common. Organized by disease, state and organ system, these educational materials, developed by ACG physician experts, are offered for the information and benefit of patients and the public.

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