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Gendux Announces Acceptance of its ADVEXIN Marketing Authorization Application for Review by the EMEA

Gene therapy targeting inherited cancer is world's first

29 Nov 2007 - Gendux Molecular Limited announced that its Marketing Authorization Application (MAA) for ADVEXINŽ ("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).
 
According to the company, 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.
 
The acceptance of the MAA for ADVEXIN will initiate the regulatory review of the Application's preclinical, manufacturing and clinical data by the EMEA. Gendux is utilizing the Exceptional Circumstances Approval rules available in Europe to expedite review of potential breakthrough therapies. The review will be based on clinical efficacy and safety results from the use of ADVEXIN in LFS and in a wide variety of non-inherited cancers with abnormal p53 tumor suppression, the target of ADVEXIN treatment. Abnormal p53 is inherited in LFS and is also the most commonly identified defective gene in all solid cancers whether inherited or acquired. An important aspect of ADVEXIN therapy is that patients' tumors can be checked to determine if they have the p53 abnormality targeted by ADVEXIN using widely available diagnostic tests.