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Biotech / Medical : Introgen Therapeutics -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (755)	11/14/2007 11:59:48 AM
From: Jibacoa	Respond to of 802

INGN announced yesterday that it had submitted the MAA to the EMEA for LFS & that it will also submit an NDA in the USA for Advexin in the next month for recurrent head and neck Cas, as it had previously stated. But the stock is unchanged & volume remains low as the shorts don't seem to be on any hurry to cover.<g> bigcharts.marketwatch.com Introgen and Gendux Submit First Marketing Authorization Application for ADVEXIN Tuesday November 13, 7:00 am ET Submission to European Medicines Regulatory Agency Targets Li-Fraumeni Syndrome Cancers DUBLIN, Ireland & AUSTIN, Texas--(BUSINESS WIRE)--Introgen Therapeutics, Inc. (NASDAQ:INGN - News) and its subsidiary, Gendux Molecular Limited (“GML”), today announced that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) for ADVEXIN®, a targeted p53 tumor suppressor therapy for the treatment of Li-Fraumeni Syndrome cancers (LFS). LFS is a cancer syndrome characterized by the inheritance of an abnormal p53 tumor suppressor. Normal p53, known as the Guardian of the Genome, suppresses cancer and tumor formation. Without p53 tumor suppression, LFS patients often develop spontaneous and widespread tumors at an early age. Frequently, multiple members of the same family suffer from this genetic disorder and there are no approved therapies to specifically treat LFS. The Company submitted the MAA under the EMEA’s Exceptional Circumstances Approval rules for breakthrough therapies for rare diseases such as LFS. Therefore, approval, if granted, will be based on clinical results from the use of ADVEXIN in LFS, a designated orphan indication for the drug in Europe, and also from results of other trials with ADVEXIN in a wide variety of non-inherited solid tumors that share the p53 biomarker abnormality, which characterizes LFS. “The submission is an important milestone achievement for the company in the development of ADVEXIN,” said Dr. Max W. Talbott, Introgen’s senior vice president of Worldwide Regulatory Affairs. “This announcement is the first of multiple anticipated registration submissions for Introgen. We are also on track to make two additional ADVEXIN submissions in 2007, one in the U.S. and one in Europe, for recurrent head and neck cancer.” Snip Bernard