Guest guest Posted February 3, 2005 Report Share Posted February 3, 2005 [Disappointing delay. I hope it's nothing serious.] Xcyte Therapies, Inc. Announces Withdrawal Of Protocol for Phase II/III Clinical Trial in Chronic Lymphocytic Leukemia and Potential Delay in Trial Initiation Wednesday February 2, 4:05 pm ET SEATTLE--(BUSINESS WIRE)--Feb. 2, 2005--Xcyte Therapies, Inc. ( " Xcyte " , the " Company " ) (Nasdaq:XCYT - News) announced today that it has withdrawn its submission to the FDA of the clinical protocol for a planned Phase II/III trial of Xcellerated T Cells in chronic lymphocytic leukemia.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. " We have been working closely with the FDA on the design of this trial since our End of Phase II meeting in September 2004, " said Ron Berenson, M.D., President and Chief Executive Officer of Xcyte Therapies. " We intend to work diligently with the FDA to resolve the remaining issues as quickly as possible. " 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, Washington. Quote Link to comment Share on other sites More sharing options...
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