Gendux AB and Introgen Therapeutics File European Orphan Drug Designation for ADVEXIN
Tuesday May 9, 8:00 am ET
STOCKHOLM, Sweden and AUSTIN, Texas, May 9 /PRNewswire-FirstCall/ -- Gendux AB and Introgen Therapeutics, Inc. announced today that Gendux AB has submitted an Orphan Drug Designation Request to the European Medicines Evaluation Agency for the use of ADVEXIN therapy in the treatment of cancer patients with Li-Fraumeni Syndrome. ( Gendux is a wholly owned subsidiary of Introgen Therapeutics, Inc.<G>)
Commenting on the use of ADVEXIN in Li-Fraumeni Syndrome, Max Talbott, Ph.D., senior vice president of Worldwide Commercialization at both Gendux and Introgen, said, "Based upon discussions with EMEA and encouraging clinical data, Gendux has filed the Orphan Drug Designation Request in Europe.
We intend to provide ADVEXIN on a compassionate use basis to qualifying patients in Europe as well as other countries including the United States.
I applaud the European regulators who have established expedited procedures designed to speed the development and approval of therapies for orphan diseases such as Li-Fraumeni Syndrome. We believe we can provide real medical benefit for those suffering from this devastating disease."
Under EMEA rules, treatments for orphan diseases such as Li-Fraumeni may be approved under "Exceptional Circumstance" provisions.
A Marketing Authorization Application filed under these provisions can be reviewed on an expedited basis. This registration approach is more streamlined than EMEA's Conditional Approval procedures. The Conditional Approval procedures are very similar to the U.S. FDA's Accelerated Approval regulations.
Robert E. Sobol, M.D., senior vice president of Clinical and Scientific Affairs said, "Cancers resulting from this syndrome are due to abnormal p53 function that is directly addressed by ADVEXIN's mechanisms of action and is the epitome of targeted molecular therapy."
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