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Published on 3/16/2006 in the Prospect News Biotech Daily.

Introgen trial of Advexin in esophageal cancer demonstrates safety, anti-tumor activity

By Lisa Kerner

Erie, Pa., March 16 - Introgen Therapeutics, Inc. said data from a phase 1/2 clinical trial of Advexin in advanced esophageal cancer patients indicate that intratumoral administration of multiple Advexin doses is safe, feasible and clinically active.

Advexin is an investigational cancer therapy that uses an adenoviral vector to deliver the p53 tumor suppressor directly to tumors, according to a company news release.

All study subjects had confirmed squamous cell carcinoma of the esophagus, were not candidates for further surgery and had become resistant to standard chemotherapy.

Nine of the 10 patients enrolled in the study had local tumor responses of stable disease, the company said. The overall one-year survival rate was 60%, and 30% of patients showed no evidence of tumor in multiple biopsies following treatment.

One patient, with a tumor that prevented swallowing, was able to swallow liquid and food after two injections of Advexin. Another patient remained progression free and alive 47 months after completing Advexin therapy, the company said.

Introgen's collaborators at Chiba University in Japan conducted the trial, and the data appears in the current issue of Cancer Science.

"Refractory esophageal cancer is a highly malignant disease, for which novel therapies are required," senior vice president of medical and scientific affairs Robert E. Sobol said in the release.

"Even in this difficult-to-treat population, Advexin demonstrated clinical activity providing local tumor control without adding significant toxicities."

Austin, Texas-based Introgen is a biopharmaceutical company that discovers, develops and commercializes targeted molecular therapies for the treatment of cancer and other diseases.


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