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New trial awaits FDA approval

Tuesday, January 21, 2003

By Marylynne Pitz, Post-Gazette Staff Writer

At the University of Pennsylvania in Philadelphia, three doctors are awaiting final approval from the Food and Drug Administration for a gene transfer trial that will use novel therapy to attack mesothelioma.

For the past eight years, Penn doctors have conducted trials with funding from the National Cancer Institute.

Dr. Steven M. Albelda, vice chief of the pulmonary, allergy and critical care division, said doctors plan to inject the interferon beta gene into patients to stimulate their immune response.

Once a patient's immune system attacks the cancerous rind that spreads like a sheet over the lungs, Dr. Larry R. Kaiser will perform surgery.

"The intent here is to remove the majority of the disease," Kaiser said, adding that earlier trials have shown that doing gene therapy first and following it with surgery may be more effective.

Dr. Daniel H. Sterman, director of interventional pulmonology at Penn's thoracic oncology gene therapy program, said the goal is to introduce tumor suppressor genes into sick patients.

The therapy, Sterman said, is experimental and will begin with low doses but no participants will be accepted until the FDA gives its final approval.

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