Introgen Therapeutics and its subsidiary Gendux Molecular have submitted a marketing authorization application to the European Medicines Agency (EMEA) for Advexin, a treatment of Li-Fraumeni Syndrome (LFS).
LFS is a cancer syndrome characterized by the inheritance of an abnormal p53 tumor suppressor. Without p53 tumor suppression, LFS patients can develop spontaneous and widespread tumors at an early age.
The companies submitted the application under the EMEA’s exceptional circumstances approval rules for rare diseases.
Max Talbott, Introgen’s senior vice president of worldwide regulatory affairs, said the company is on track to make Advexin submissions in the U.S. and Europe this year for recurrent head and neck cancer.