Healthcare Industry News: intratumoral
News Release - March 16, 2006
Phase I/II Clinical Data Demonstrate Safety and Antitumor Activity of Introgen's ADVEXIN(R) in Patients With Advanced Esophageal CancerAUSTIN, Texas, March 16 (HSMN NewsFeed) -- Introgen Therapeutics, Inc. (Nasdaq: INGN ) today announced the publication of positive data from a Phase I/II clinical trial of ADVEXIN® 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 percent. No evidence of tumor in multiple biopsies following treatment was observed in 30 percent. 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, M.D., 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.
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.
About Introgen Therapeutics, Inc.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle tumor suppressor therapies to treat a wide range of cancers using tumor suppressors, cytokines and genes. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.
Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its ADVEXIN clinical development program for treatment of esophageal and head and neck cancer. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene- based drugs in general, dependence upon proprietary technology and the current competitive environment, 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, Introgen's 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 including its filings on Form 10-K and Form 10-Q. 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.
Source: Introgen Therapeutics
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