Xcyte leukemia protocol withdrawal
This article was originally published in Pharmaceutical Approvals Monthly
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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