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news.Shares in Xcyte Therapies plunged almost 13% in pre-market trading, after the company announced the withdrawal of the trial protocol submission for its phase II/III leukemia trial.
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Xcyte withdrew its FDA submission of the clinical protocol for a planned phase II/III trial of Xcellerated T-cells in chronic lymphocytic leukemia, after the FDA requested further 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 Dr Ron Berenson, president and CEO 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.