INGN Opened with an UG after announcing results from PIIs showing statistically significant correlation between abnormal p53 abnormalities & results of Advexin treatment in several types of Ca.s
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Introgen Presents Biomarker Data Demonstrating Abnormal p53 Predicts ADVEXIN Efficacy in Head and Neck, Lung, Prostate and Li-Fraumeni Cancers
Thursday September 27, 8:00 am ET
Data to Be Used to Support U.S. and European Regulatory Filings
DALLAS & AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News) today reported the results of new data analysis from multiple Phase 2 clinical studies showing a statistically significant correlation between the abnormal p53 biomarker and tumor response after treatment with ADVEXIN in patients with head and neck, lung, prostate and Li-Fraumeni Syndrome cancers. These data were presented at the Mary Crowley Medical Research Center Conference on Cancer Gene Therapy in Dallas.
The Company will utilize these biomarker findings for its ongoing analyses of its randomized Phase 3 trial comparing ADVEXIN therapy to methotrexate for the treatment of recurrent head and neck cancer.
Prior to the initiation of the Phase 3 analyses, the Company gained consent from the U.S. Food and Drug Administration to amend the ADVEXIN Investigational New Drug Application and Statistical Analysis Plan to include analyses of patient populations identified by the abnormal p53 biomarker. These prospective analyses and evaluations will be included in the ADVEXIN U.S. and international regulatory submissions.
"These findings provide important support for our regulatory filings," said Max W. Talbott, Ph.D., Introgen's senior vice president of Worldwide Commercial Development and Regulatory Affairs. "They provide further justification for incorporating p53 biomarker analyses in our regulatory submissions for recurrent head and neck cancer in the United States and will advance our European Union application for ADVEXIN in Li-Fraumeni Syndrome, an inherited cancer disorder characterized by the development of multiple tumor types with abnormal p53."
In 54 late-stage cancer patient samples evaluated from the Company's Phase 2 studies, tumor response after ADVEXIN monotherapy was observed in 35 percent of patients with the abnormal p53 biomarker and all tumor responses occurred in the abnormal p53 biomarker group (p = 0.0013). The majority of these patients had recurrent disease after receiving standard therapies.
Introgen has previously reported study results demonstrating a statistically significant correlation between the abnormal p53 biomarker and increased survival after ADVEXIN therapy in head and neck cancer patients.
"The results presented today confirm and extend previous biomarker data correlating the abnormal p53 biomarker with increased tumor responses following ADVEXIN treatment and support its use as a biomarker to predict ADVEXIN efficacy," said John Nemunaitis, M.D., a principal investigator of the studies and executive director of the Mary Crowley Medical Research Center.
"Importantly, the data from multiple tumor types indicate an absolute correlation of tumor response and abnormal p53 as 100 percent of the responding tumors had the abnormal p53 biomarker."
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Now we have to wait for Adam Feuerstein to come out with a note showing that left handed patients had a similar 100% correlation, in the mean time the short position was still > 40x the DAV.<g>
Bernard |
