Introgen Therapeutics, Inc, a developer of targeted molecular therapies for cancer, and its subsidiary Gendux Molecular Limited, announced that the European Medicines Agency (EMEA) has accepted for review the company's Marketing Authorization Application (MAA) for Advexin (p53 tumour suppressor therapy) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck. Advexin is an innovative gene therapy designed to restore p53 tumour suppression that is blocked in the majority of tumours. If approved, Advexin will be the first gene therapy product approved for use in Europe. Introgen and Genedux announced the submission of the Advexin MAA on June 30, 2008.
"This acceptance of the Advexin MAA by the EMEA marks an historic point in the growth of personalized medicine and the treatment of head and neck cancer," said Max Talbott, Ph D, Introgen's senior vice president of worldwide commercial development. "This action by the EMEA underscores the rapidly increasing importance of biomarkers in the development and regulatory approval processes for targeted therapeutics. We look forward to working with the EMEA during the Advexin review process, which we hope will lead to the first gene therapy product in Europe."
The MAA is based upon a comprehensive clinical data package which includes the results from Introgen's open-label, multi-center, randomized, comparative phase-3 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. The primary efficacy endpoint of the phase-3 study was survival in either the intent-to-treat (ITT) or biomarker patient population. The secondary efficacy endpoint was tumour response in either the ITT or biomarker patient population.
"We believe that the Advexin phase-3 study data demonstrate clear and powerful evidence that the therapy results in significant survival and tumour response benefits for patients who possess p53 biomarkers that are positive for Advexin efficacy," stated Robert E Sobel, MD, senior vice president, medical and scientific affairs at Introgen. "We are confident in the data package that was submitted to the EMEA, particularly in light of the increasingly important role that biomarker are playing in the area of drug development, and we eagerly await the result of the agency's review of the Advexin MAA."
The MAA acceptance triggers the initiation of EMEA's regulatory review process. The review timelines are solely controlled by the agency and the company can make no guarantees as to the timing of the agency's response to the MAA.
Advexin p53 therapy 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.
Introgen Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases.