Gendux AB and Introgen Therapeutics, Inc. announced Gendux was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that Advexin p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS). LFS is a genetic disorder characterized by inherited mutations in the p53 tumour suppressor gene.

EU Orphan 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. The Orphan Designation recommended by the EMEA Committee for Orphan Medicinal Products must be ratified by the European Commission, and is expected within 30 days. Gendux is a wholly owned subsidiary of Introgen Therapeutics, Inc.

Dr. Max W. Talbott, senior vice president of worldwide commercial development and regulatory affairs at both Introgen and Gendux said, "We are very encouraged by the recognition of the unique ability of Advexin to treat the tumours of Li-Fraumeni Syndrome cancer patients without the toxicity that characterizes many other anti-cancer treatments. We plan to seek expedited registration of Advexin in Europe utilizing the Exceptional Circumstances provisions of the EMEA's registration rules. The European registration efforts compliment our advancing registration program in the United States and will provide for Advexin's availability in both major biopharmaceutical markets."

Positive clinical findings reported at the 2006 American Society of Gene Therapy and American Society of Clinical Oncology conferences demonstrated the utility of Advexin p53 therapy in Li-Fraumeni cancer. Introgen previously announced it is making Advexin p53 therapy available on a compassionate use basis to qualified Li-Fraumeni Syndrome patients.

Advexin is a targeted molecular therapy with broad applicability in a wide range of tumour types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumour suppressor function, associated with cancer initiation, progression and treatment resistance. 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 Advexin. Advexin has demonstrated clinical activity in a number of solid tumour types in multiple phase 1, 2 and 3 clinical trials conducted worldwide. A request for accelerated approval for Advexin is now pending at the US Food and Drug Administration (FDA). The FDA has selected Advexin as a fast track program for an unmet medical need and has designated Advexin for orphan drug use for recurrent head and neck cancer.

Li-Fraumeni Syndrome (LFS) is an inherited genetic disorder that greatly increases the risk of developing several types of cancer typically with initial occurrence at a young age. The majority of LFS families have inherited mutations in the p53 tumour suppressor gene. The treatment of Li- Fraumeni tumours with Advexin p53 represents therapy targeted to the molecular defect underlying the cause and progression of these cancers.