INTROGEN'S ADVEXIN GRANTED ORPHAN DRUG DESIGNATION IN EUROPE

Introgen Therapeutics announced that Gendux, its wholly owned subsidiary, was notified by the European Medicines Agency Committee for Orphan Medicinal Products that Advexin p53 therapy has received orphan drug designation in Europe for the treatment of Li-Fraumeni syndrome, a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. Orphan drug designation confers a number of regulatory benefits for the product including access to protocol assistance, reduced regulatory fees and a 10-year period of marketing exclusivity from the date of approval.

Positive clinical findings have demonstrated the utility of Advexin p53 therapy in Li-Fraumeni cancer. Introgen previously announced it is making the therapy available on a compassionate-use basis to qualified Li-Fraumeni syndrome patients.

Advexin has demonstrated increased survival and durable locoregional disease control in recurrent head and neck cancer patients. Prognostic biomarkers can identify patients most likely to respond to the drug. Advexin already has FDA orphan drug and fast-track designation.