Another grain of salt, which may help ADVEXIN been approved by the EMEA for LFS & may help on its others current trial taking into account the abnormalities in the p53 biomarker.<g>
Introgen's ADVEXIN Demonstrates Clinical Benefit in Inherited Cancer.
Wednesday May 30, 9:33 am ET
Case History Highlighted in AACR Cancer Journal
AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News) announced today the publication of data describing the dramatic clinical benefit of its lead product ADVEXIN in a patient with a rare inherited form of cancer known as Li-Fraumeni Syndrome (LFS), a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene.
This is the first reported treatment of Li-Fraumeni tumors with a therapy targeted to the underlying molecular cause of the disorder.
These cancers are due to inherited abnormalities of p53 function which is directly addressed by ADVEXIN treatment. In addition, the results of the study evaluated biomarkers which confirmed the molecular mechanism of activity of ADVEXIN.
These biomarkers will guide ADVEXIN therapy of other cancers with p53 abnormalities, which is one of the most common molecular defects found in virtually all types of cancer.
The patient was treated as part of a study at the Mary Crowley Medical Research Center in Dallas, TX and the importance of the findings were underscored by publication this week in the Spotlight on Clinical Response editorial highlights section of the current issue of Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research.
ADVEXIN treatment of a tumor in an LFS patient led to improvement of tumor-related symptoms and resulted in a complete response as determined by positron emission tomography (PET) scans.
In addition, molecular biomarker studies using tumor biopsies before treatment detected abnormal levels of p53 protein predictive of ADVEXIN efficacy. Tumor biopsies analyzed after therapy identified restoration of p53 tumor suppressor function including suppression of tumor growth and induction of tumor cell death validating ADVEXIN's mechanisms of action.
"This case study showcases and provides proof of the principle for the therapeutic application of targeted ADVEXIN therapy in tumors with p53 abnormalities that are among the most common and fundamental molecular defects in cancer," said Neil Senzer, M.D., Scientific Director, Mary Crowley Medical Research Center, and lead author of the article.
"ADVEXIN's mechanism of action is targeted to restoring p53 tumor suppressor function that is abnormal in Li-Fraumeni tumors and in many other types of cancer."
ADVEXIN is being developed for European markets by Gendux AB, a subsidiary of Introgen Therapeutics, Inc. The European Medicines Agency (EMEA) has designated, and the European Union has confirmed, ADVEXIN p53 therapy as an Orphan Drug for the treatment of LFS.
A Letter of Intent to the EMEA regarding Marketing Authorization Application for the approval of ADVEXIN to treat LFS was filed under the Exceptional Circumstances Approval procedures in the EU.
Collaborators on this publication included clinicians from Mary Crowley Medical Research Center, Sammons Cancer Center, Baylor University Medical Center, The Royal Marsden Hospital NHS Foundation Trust, Imperial College London Hammersmith Campus, and the Institute of Cancer Research in the United Kingdom.
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