Applied Immune Sciences Inc. received approval from theRecombinant DNA Advisory Committee of the National Institutes ofHealth for an initial clinical trial of the company's Avectin genetherapy for treatment of metastatic breast cancer.Annemarie Moseley, Applied Immune's vice president of clinicalresearch, said the Santa Clara, Calif.-based company will file aninvestigational new drug application with the FDA and expects tobegin the Phase I study by the second quarter of 1995.The clinical trial will involve up to 20 patients at the Duke UniversityMedical Center in Durham, N.C. Moseley said the company expects toenroll participants over two years.Applied Immune's gene therapy involves using Avectin, a non-viralgene transfer system, to place the interleukin-2 gene into tumor cells,which have been removed from the patients. Once the geneticallymodified tumor cells are irradiated, they are returned to the patients andare intended to enhance production of killer T cells, which will attackthe tumor.Moseley said each patient in the study will receive four injections ofthe modified tumor cells. Investigators will try to determine whetherthe modified tumor cells increase T cell production. _ Charles Craig
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