Xcyte Pulls Protocol for Phase II/III Trial in Chronic Lymphocytic Leukemia

Xcyte Therapies has withdrawn its submission to the FDA of the clinical protocol for a planned Phase II/III trial of Xcellerated T Cells in chronic lymphocytic leukemia.

The FDA requested the withdrawal to allow additional discussion of the design of the trial. The protocol will be resubmitted to the FDA as a draft protocol.

Xcyte expects that these actions and additional discussions may result in a delay in the initiation of the trial beyond the second quarter of 2005.

Xcyte is scheduled to meet with the FDA in mid-February to discuss the chemistry, manufacturing and controls submission related to this trial and to the planned transfer of the company's manufacturing operations to its newly completed facility in Bothell, Wash.