Introgen Therapeutics (INGN) Announces EMEA Accepts Review of MAA for ADVEXIN(R)
Introgen Therapeutics, Inc. (NASDAQ: INGN) today announced that the European Medicines Agency has accepted for review the company's Marketing Authrorization Application for ADVEXIN(R) (p53 tumor 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 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. Introgen and Genedux announced the submission of the ADVEXIN MAA on June 30, 2008.
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 or biomarker patient population. The secondary efficacy endpoint was tumor response in either the ITT or biomarker patient population.
Introgen Therapeutics, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of targeted molecular therapies for the treatment of cancer and other diseases.
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 or biomarker patient population. The secondary efficacy endpoint was tumor response in either the ITT or biomarker patient population.
Introgen Therapeutics, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of targeted molecular therapies for the treatment of cancer and other diseases.
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