Still the new releases aren't helping the stock price.<g>
Increased Survival and High Response Rates Reported for Introgen's ADVEXIN p53 Therapy
Monday June 5, 8:00 am ET
Molecular Biomarker Predicts ADVEXIN Activity
ATLANTA, June 5 /PRNewswire-FirstCall/ -- Researchers at Introgen Therapeutics, Inc. (Nasdaq: INGN - News) 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.
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