Introgen's Advexin may benefit from FDA approval of new therapy for head, neck cancer

By Lisa Kerner

Erie, Pa., March 3 - Introgen Therapeutics, Inc. said the Food and Drug Administration's approval of Bristol-Myers Squibb's Erbitux (centuximab), a new therapy for patients with head and neck cancer, affirms Introgen's approval approach for its drug candidate, Advexin.

Advexin p53 therapy targets abnormal p53 tumor suppressor function, a molecular defect associated with cancer initiation, progression and treatment resistance, according to a company news release.

Erbitux was approved for use as a monotherapy in recurrent head and neck cancer patients on the basis of a phase 2 trial with 103 patients, which showed a response rate of 13%.

Introgen's Advexin demonstrated equal or improved activity in phase 2 trials involving 217 patients where response rates of 10% to 29% were observed, according to the release.

"It is important to realize that Erbitux is not curative therapy in recurrent head and neck cancer and that Advexin may be used in later-stage patients who have failed earlier treatment with Erbitux or any other therapy," Introgen senior vice president of clinical affairs Robert E. Sobol said in the release.

"In addition, Introgen has reported data showing synergistic activity from combining Erbitux and Advexin and we believe patients may ultimately be given both therapies."

Introgen said in clinical studies, the combination of Advexin and Erbitux therapy resulted in a two-fold to six-fold greater reduction in tumor size compared to either agent used alone.

The estimated 400,000 patients worldwide with head and neck cancer could benefit from any improvement over previously available treatment approaches, the company said.

Introgen is a biopharmaceutical company based in Austin, Texas, focused on the discovery, development and commercialization of well-tolerated, targeted molecular therapies for the treatment of cancer and other diseases.

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