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Xcyte leukemia protocol withdrawal

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

FDA requests withdrawal of a Phase II/III trial protocol of Xcyte's Xcellerated T Cells oncologic for use in chronic lymphocytic leukemia "to allow additional discussion of the design of the trial," Xcyte says Feb. 2. The firm now anticipates "a delay in the initiation of the trial beyond the second quarter of 2005." The firm is meeting with FDA in mid-February to discuss the chemistry, manufacturing & controls submission related to the trial. Xcellerated T Cells are also in development for multiple myeloma and non-Hodgkin's lymphoma...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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