Gendux Announces Acceptance of Its ADVEXIN Marketing Authorization Application for Review by the European Medicines Evaluation Agency
Published: Nov 27, 2007
DUBLIN--(BUSINESS WIRE)--Gendux Molecular Limited (“Gendux”) announced today that its Marketing Authorization Application (“MAA”) for ADVEXIN® (“contusugene ladenovec”) has been accepted for technical review by the European medicines regulatory authority (the “EMEA”) for the treatment of an inherited cancer, Li-Fraumeni Syndrome (“LFS”). Gendux announced the submission of its MAA for ADVEXIN with the EMEA on 13th November 2007. ADVEXIN is the first treatment specific for an inherited cancer syndrome. ADVEXIN 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 US.