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news.Introgen Therapeutics and its subsidiary Gendux Molecular have reported that a marketing authorization application has been submitted to the European Medicines Agency for Advexin, a targeted p53 tumor suppressor therapy for the treatment of Li-Fraumeni Syndrome cancers.
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The company submitted the marketing authorization application (MAA) under the European Medicines Agency’s exceptional circumstances approval rules for breakthrough therapies for rare diseases such as Li-Fraumeni Syndrome (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 companies say that Advexin is a targeted molecular therapy with the potential to be broadly applicable across a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance.
Max Talbott, senior vice president of worldwide regulatory affairs at Introgen, said: “The submission is an important milestone achievement for the company in the development of Advexin. 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 US and one in Europe, for recurrent head and neck cancer.”