Cancer gene therapy news backgrounder: New ideas fuel next generation gene therapy research

ctor taken up by the bone marrow cells.

Roth, now chairman of the Department of Thoracic and Cardiovascular Surgery, had more success. He found that an abnormal or missing p53 gene in lung tumors could be successfully replaced in experimental animals. The p53 gene, which normally acts as a brake against uncontrolled cell growth, is missing or mutated in about half of human cancers, and dysfunctional in most of the rest.

Based on the animal experiments, the first lung cancer patient underwent gene therapy in early 1995, and in mid-1996, Roth and his group published a study describing the first reported successful replacement of a defective p53 tumor suppressor gene. M. D. Anderson licensed the finding to the biotech company, Introgen, which Roth helped create and for which he is now a paid consultant. "It all started here at M. D. Anderson with the concept, vector development, preclinical trials and the first phase of testing," says Roth. "This agent has clinical benefit, and because of its novelty and lack of interest by major pharmaceutical companies, the only way to make it available to patients was to start a biotech company. But it has been a long road."

Introgen conducted phase II studies on the therapy, which it calls Advexin, and found that lung tumors shrank in over half of the patients who used it when combined with radiation therapy. Moreover, there have been unexpected long-term survivors, and these findings have sent the company to the FDA for fast track approval, which is currently being considered. More than 20 completed or ongoing trials are testing Advexin in such solid tumors as lung, head and neck, breast and ovarian. Some of these trials are now ongoing at M. D. Anderson, as well as at other cancer centers around the world.

But the drug has limitations. It uses an adenovirus, the microbe that causes the common cold, as a "vector" - a sort of taxicab - that carries genetic material directly into cancer cells. The vir

Contact: Nancy Jensen
University of Texas M. D. Anderson Cancer Center

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