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Phase 1/2 Clinical Data Demonstrate Safety and Antitumor Activity of Introgen's Advexin in Patients With Advanced Esophageal Cancer

AUSTIN, T.X. -- March 16, 2006 -- Introgen Therapeutics, Inc. today announced the publication of positive data from a phase 1/2 clinical trial of Advexin(R) in advanced esophageal cancer patients.

Intratumoral administration of multiple Advexin doses was shown to be safe, feasible and clinically active. Nine of 10 patients had local tumor responses of stable disease and overall one-year survival was 60%. No evidence of tumor in multiple biopsies following treatment was observed in 30%.

Advexin is an investigational cancer therapy that utilizes an adenoviral vector to deliver the p53 tumor suppressor directly to tumors. Introgen's collaborators at Chiba University in Japan conducted the trial, and the data appear in the current issue of Cancer Science.

"Refractory esophageal cancer is a highly malignant disease, for which novel therapies are required," said Robert E. Sobol, MD, senior vice president, Medical and Scientific Affairs, at Introgen. "Even in this difficult-to-treat population, Advexin demonstrated clinical activity providing local tumor control without adding significant toxicities."

The trial enrolled 10 patients with confirmed squamous cell carcinoma of the esophagus who were not candidates for further surgery and who had become resistant to standard chemotherapy. At the time of entry into the trial, five of the patients had tumors growing into adjacent organs.

Overall responses included six patients with stable disease for more than one year. One patient who entered the trial with a tumor that prevented swallowing was able to swallow liquid and meals after two injections of Advexin. Another patient remained progression free and alive 47 months after completing Advexin therapy. As in other clinical trials, Advexin therapy was well tolerated.

"In addition to Advexin's activity as monotherapy in advanced disease, recent clinical data show that Advexin in combination with radiation and chemotherapy induced high response rates in other cancers and we believe that Advexin should also be studied in combination with chemoradiation in esophageal cancer as initial therapy," said Hideaki Shimada, M.D., Professor at Chiba University Graduate School of Medicine and the lead author of the publication.

About Advexin
Advexin p53 therapy is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance.


SOURCE: Introgen Therapeutics, Inc.

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