ATLANTA, June 5 /PRNewswire-FirstCall/ -- Researchers at Introgen Therapeutics, Inc. and their clinical collaborators have identified a set of prognostic indicators associated with high response rates and increased survival in Phase 2 trials of ADVEXIN in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN). The identification of prognostic indicators of ADVEXIN activity complies with recent FDA biomarker initiatives to accelerate the approval of oncology products by predicting the patient populations most likely to benefit from a specific cancer therapy. The population benefiting from ADVEXIN included patients who are least likely to respond to standard therapies. The data are being reported concurrently at the annual meeting of the American Society of Clinical Oncology (ASCO) and at the annual meeting of the American Society of Gene Therapy (ASGT).
A molecular biomarker predictive of ADVEXIN activity is abnormal p53 function detected in tumor tissues by a routine laboratory test. In patients with the abnormal p53 marker, ADVEXIN therapy was correlated with a statistically significant increase in median survival of 11 months compared to only 3 months for patients without abnormal p53. Patients with abnormal p53 function are known to have a poor prognosis when treated with standard therapies. In addition to the molecular biomarker, clinical prognostic biomarkers were identified correlating with statistically significant increases in survival, tumor response and durable tumor growth control following ADVEXIN therapy. These clinical biomarkers included prior chemotherapy or radiotherapy consistent with ADVEXIN’s mechanism of action of inducing tumor death in cells with DNA damage from previous treatments.
John Nemunaitis, M.D., Medical Director of the Mary Crowley Medical Research Center and the lead clinical investigator of the study commented, “It is also important to note that the beneficial effects of ADVEXIN are obtained without significant toxicities associated with standard treatments which further support future application of this therapy.”
The prognostic biomarkers defined target populations of patients with high tumor response rates and increased survival following ADVEXIN therapy. Prognostic factors defining targeted populations with response rates up to 29 percent and durable tumor growth control rates of 57 percent were observed. Importantly, these tumor responses were associated with a statistically significant increase in median survival. The median survival of patients with durable tumor growth control in this group was 12.4 months compared to 5.1 months for the entire study population
Max Talbott, Ph.D., Introgen’s senior vice president, World Wide Commercial Development and Regulatory Affairs stated, “These clinical findings have very important regulatory implications. The high frequency of tumor responses and their correlation with increased survival provide compelling data which compare favorably or surpass clinical results that supported the approval of other recently approved cancer therapies.”
The Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Medicare & Medicaid Services (CMS) previously announced the Oncology Biomarker Qualification Initiative to expedite the development of novel cancer treatments. Biomarkers are clinical or biological indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests, laboratory tests on blood or tissue samples as well as by clinically defined parameters. This initiative was developed to employ biomarkers as a way of speeding the development and evaluation of new cancer therapies.
Robert E. Sobol, M.D., Introgen’s senior vice president, Medical and Scientific Affairs said, “The key biomarkers that define target patient populations benefiting most from ADVEXIN also identify patients that respond very poorly to standard therapies who need new treatment approaches. The finding that abnormal p53 function is a predictive marker for ADVEXIN efficacy is consistent with its expected mechanism of action -- restoration of p53 function -- and is the epitome of targeted molecular therapy.”
Following the conclusion of the ASGT and ASCO conferences, Introgen will host a future conference call with cancer experts to discuss the importance and application of the reported findings.
Another presentation at ASCO (Abstract # 2564) described the results of a Phase 1 trial of ADVEXIN in patients with advanced non-small cell cancer which showed that multiple courses of ADVEXIN alone or in combination with chemotherapy were well tolerated and demonstrated clinical activity. The study was conducted in Japan by researchers at Okayama University, Tohoku University, Jikei University, and Tokyo Medical University.
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. ADVEXIN has demonstrated increased survival and durable tumor growth control in recurrent head and neck cancer patients. Prognostic biomarkers can identify patients most likely to respond to ADVEXIN. ADVEXIN has demonstrated clinical activity in a number of solid tumor types in multiple phase 1, 2 and 3 clinical trials conducted worldwide. A request for accelerated approval for ADVEXIN is now pending at the U.S. Food and Drug Administration (FDA). FDA has selected ADVEXIN as a fast track program for an unmet medical need and has designated ADVEXIN for orphan drug use for recurrent head and neck cancer.
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 therapies to treat a wide range of cancers using tumor suppressors and cytokines. 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. 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.
Editor’s Note: For more information about the Oncology Biomarker Qualification Initiative to expedite the development of novel cancer treatments, please see: http://www.fda.gov/bbs/topics/news/2006/NEW01316.html
Editor’s Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen’s Website at: http://www.introgen.com .
Contact: Introgen Therapeutics, Inc. C. Channing Burke (512) 708 9310 Ext. 322 Email: c.burke@introgen.com
Introgen Therapeutics, Inc.
CONTACT: C. Channing Burke of Introgen Therapeutics, Inc., +1-512-708-9310Ext. 322, or c.burke@introgen.com
