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Press Release Source: Introgen Therapeutics, Inc.
Introgen's ADVEXIN(R) Therapy Demonstrates Survival Advantage in Patients With Advanced Cancer
Friday December 13, 1:30 pm ET
Cancer Patient Reaches Four-Year Survival Mark After Treatment With ADVEXIN
SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - News) announced results from its phase 2 studies demonstrating that treatment with its ADVEXIN therapy provided a survival advantage to patients with recurrent head and neck cancer, who were ineligible for surgery. These data were presented by John Nemunaitis, M.D., director of clinical research and oncologist with U.S. Oncology, at the 11th International Conference on Gene Therapy of Cancer held in San Diego, Calif.
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The phase 2 studies examined the dose-dependence of survival and safety parameters following intratumoral administration of ADVEXIN in patients with recurrent squamous cell carcinoma of the head and neck (Abstract # 3). Data presented were derived from two large phase 2 studies that utilized different doses of single-agent ADVEXIN.
Analysis of phase 2 data suggests an early survival advantage with high- dose treatment (75 day improvement in median survival), compared to the low dose, which also appeared to increase rates of tumor-growth control (stable disease or better) and stabilized performance status. Remarkably, one patient treated at the higher dose has remained on the ADVEXIN therapy for more than 4 years. Typically, the midpoint of known survival time is six to twelve months for end-stage head and neck cancer patients who have failed conventional treatments such as surgery or chemotherapy. Additionally, this patient has not experienced significant side effects during treatment.
"These results are exciting because they provide evidence that ADVEXIN has significant therapeutic potential in a very difficult-to-treat patient population," said Dr. Nemunaitis, Introgen's collaborator on phase 2 and phase 3 studies. "Moreover, these data suggest that ADVEXIN treatment may increase survival, and validate the ongoing phase 3 studies."
Clinical Trial Information
Patients interested in participating in a clinical trial evaluating ADVEXIN in the treatment of head and neck cancer should call 866-631-4646 or email clinicaltrials@introgen.com .
Introgen is a leader in the development and production of gene-based drugs for the treatment of cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial-scale, cGMP manufacturing facility. Through more than 20 clinical trials, the company has treated hundreds of patients with thousands of doses of its lead product candidate, ADVEXIN® p53 therapy. Introgen is conducting two controlled, randomized phase 3 clinical trials with ADVEXIN for the treatment of head and neck cancer, a phase 2 study in breast cancer, as well as phase 1 trials in prostate, ovarian, bladder, and brain cancers, and completed phase 2 studies in lung and head and neck cancers.
Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties. Such forward-looking statements include, but are not limited to, those relating to Introgen's future success with its clinical development program or registration program for ADVEXIN. 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, including its quarterly report on Form 10-Q filed on November 13, 2002. 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: www.introgen.com .
Contact:
Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322
Email: c.burke@introgen.com
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Source: Introgen Therapeutics, Inc. |
