Introgen Therapeutics and its subsidiary Gendux Molecular have announced that the European Medicines Agency has accepted for review the company's marketing authorization application for Advexin for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck.
Advexin is an innovative gene therapy designed to restore p53 tumor suppression that is blocked in the majority of tumors. If approved, Advexin will be the first gene therapy product approved for use in Europe.
The marketing authorization application (MAA) is based upon a comprehensive clinical data package which includes the results from Introgen's open-label, multi-center, randomized, comparative Phase III study of Advexin in patients with recurrent, refractory squamous cell carcinoma of the head and neck. This pivotal trial successfully achieved both the study's primary and secondary efficacy endpoints in the p53 biomarker patient population which were each prospectively designated.
Max Talbott, Introgen's senior vice president of worldwide commercial development, said: "This acceptance of the Advexin MAA by the European Medicines Agency (EMEA) marks an historic point in the growth of personalized medicine and the treatment of head and neck cancer.