Introgen (INGN) off 23% on this, which might constitute extra delay, expense, and hurdles for its Advexin BLA for head and neck cancer:
>>Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for ADVEXIN in Advanced Head and Neck Cancer in First Half of 2008
Thursday December 20, 7:00 am ET
AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News) announced today that upon the recommendation of its external regulatory and clinical advisors, the Company will include additional patient tissue samples from its Phase 3 trials for p53 biomarker analyses to predict ADVEXIN efficacy to strengthen its U.S. and European regulatory filings. This recommendation was made by the advisors without knowledge of Introgen’s Phase 3 clinical trial results.
The Company expects to announce top-line Phase 3 data and submit its Biologics Licensing Application (BLA) and Marketing Authorization Application (MAA) for ADVEXIN for head and neck cancer in the first half of 2008. The Company’s MAA for ADVEXIN for the potential treatment of Li-Fraumeni Syndrome, a genetically inherited cancer, was accepted for filing by the European Medicines Agency (EMEA) last month under the EMEA’s Exceptional Circumstances rules.
The additional tissue samples, which were previously unavailable, can now be collected upon appropriate consent and, in some cases, Institutional Review Board (IRB) approvals. The Company expects to capture an additional 20 percent or more of biomarker data through this effort, which its advisors believe will substantially strengthen the clinical data portion of its regulatory filings.
“The Company feels that evaluation of all available data is critical to supporting the strongest possible regulatory application for ADVEXIN as a new treatment for patients with advanced head and neck cancer,” said Max W. Talbott, Introgen’s senior vice president of Regulatory Affairs.
Abnormality of the p53 tumor suppressor is one of the most common and fundamental molecular defects in cancer and the target of ADVEXIN p53 therapy. Introgen has previously reported data from its earlier trials in head and neck, lung, prostate and Li-Fraumeni demonstrating statistically significant correlations between p53 biomarkers, tumor response or increased survival following treatment with ADVEXIN. The efficacy evaluation of the Phase 3 study will incorporate molecular biomarker analyses that assess p53 abnormalities and p53 protein levels in patients’ pre-treatment tumor samples.<<
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I don't follow them as much as I used to . . . Jibacoa would have more insight now.
Cheers, Tuck |
