Genetic Therapy Inc. hopes to begin a clinical trial this summer witha gene therapy designed to battle cancer patients' rejection ofallogeneic bone marrow transplants by neutralizing donor T cells thatcause graft vs. host disease.
The Gaithersburg, Md.-based company received approval for thestudy last week from the Recombinant DNA Advisory Committee(RAC) of the National Institutes of Health. If the FDA approves theclinical trial it will be conducted in multiple myeloma patients byNikhil Munshi and Bart Barlogie of the University of Arkansas forMedical Sciences.
James Barrett, chairman and CEO of Genetic Therapy, said the studyis based on research showing that the same donor T cells responsiblefor graft vs. host disease in allogeneic bone marrow transplants alsoinitially attack the transplant recipients' myeloma tumors.
To combat the potentially fatal graft vs. host disease, Barrett said,Genetic Therapy has proposed inserting a thymidine kinase gene intothe bone marrow donor's T cells prior to the transplant, setting themup for the kill by subsequent treatments with ganciclovir.
Barrett said clinical data demonstrate that graft vs. host diseasestrikes about three weeks after infusion of the donor T cells.
"If the patient begins to develop graft vs. host disease," he said, "theganciclovir will be administered to destroy the T cells."
Then the patients can receive additional doses of donor T cells,equipped with the fail safe mechanism, to continue their assault onthe myeloma tumors. _ Charles Craig
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