Introgen asks FDA to O.K. Advexin

Chain Drug Review,  August 18, 2008  

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AUSTIN, Texas -- Introgen Therapeutics Inc. became the first company to apply for Food and Drug Administration approval of a gene therapy drug, Advexin, which is used to treat recurring heed and neck cancers. The company, based here, is also seeking approval to market the medication in Europe.

Advexin is formulated to attack hard-to-treat cancers in conjunction with such other therapies as chemotherapy and radiation.

Approval of Advexin would open the door for approval of Introgen's stable of gene therapy drugs.

Experts note Introgen's groundbreaking accomplishment. "It's a major milestone for gene therapy because it's a first-in-class drug;' comments Dawson James Securities analyst Stephen Dunn.

Introgen has requested an FDA priority review for Advexin, which it has been developing for 14 years.

If the FDA grants the designation, it could make a decision in as little as six months. Without priority review a decision could take up to about a year.

COPYRIGHT 2008 Racher Press, Inc.
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