Cellcor Inc., of Newton, Mass., submitted an investigational new drugapplication with the FDA for the use of autolymphocyte therapy (ALT)in its first infectious disease application, chronic hepatitis B.ALT is the ex vivo polyclonal activation of cytotoxic and helper T cellsthat, when returned to the patient, are believed to search out foreigntargets such as cancer or a virus. ALT currently is in a pivotal Phase IIItrial for metastatic kidney cancer.In a preclinical study of ALT in chimpanzees chronically infected withthe human hepatitis B virus, a variety of liver function, clinicalchemistry and hematological parameters indicated no liver or systemictoxicity was associated with the infusion of the activated T cells.Analysis of the liver biopsy material obtained before the beginning ofthe study and following final infusion substantiated the safety of theinfusions. The biopsies also revealed moderate decreases in hepatitis Bantigen levels, Cellcor said.
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