EMEA accepts Gendux' Advexin MAA
Ireland's Gendux Molecular says that its Marketing Authorization Application for Advexin (contusugene ladenovec) has been accepted for technical review by the European Medicines Agecny (EMEA) for the treatment of an inherited cancer, Li-Fraumeni Syndrome.
The drug is claimed to be the first treatment specific for an inherited cancer syndrome. It acts by reversing one of the most common cancer genetic defects, abnormal p53 tumor suppressor levels that are inherited in Li-Fraumeni patients and which are found in the majority of non-inherited cancers. Advexin is also being developed for head and neck cancer and filings for this indication are anticipated before the end of 2007 both in Europe and the USA.
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