Introgen Therapeutics Inc plans to file an application for its adenoviral p53 product candidate, Advexin, with the European Agency for the Evaluation of Medicinal Products (EMEA). Advexin is a treatment for head and neck cancer. The EMEA is the European regulatory organization responsible for the approval of new drugs and biologics in Europe and is the European equivalent of the United States Food and Drug Administration (FDA). Currently, Introgen is enrolling head and neck cancer patients in two global phase 3 clinical trials in the United States and Europe.

Introgen also announced that the European filing will be submitted simultaneously with the previously scheduled submission of a Biologics License Application (BLA) in the United States to the FDA for Advexin, planned for 2004.

Max Talbott, Introgen's senior vice president of worldwide commercial development said, "I am pleased to report Introgen's decision to file an application for Advexin in Europe, a move which will strengthen our overall regulatory and commercial plans for the product. Our plan has always been to provide this novel drug to as many cancer patients as possible with the hope of improving outcomes; by expanding into Europe, we will be doing just that."

The EMEA was established in 1993 and authorizes the marketing of medical products in the European Community.