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WIRE)--Feb. 2, 2005--Xcyte Therapies, Inc. ("Xcyte", the "Company") (Nasdaq:XCYT - News) announced today that it has withdrawn its submission to the FDA of the clinical protocol for a planned Phase II/III trial of Xcellerated T Cells in chronic lymphocytic leukemia.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.
Note: Certain of the statements made in this press release are forward-looking, such as those, among others, relating to our ability to reach agreement with the FDA on issues related to the design of the planned Phase II/III trial of Xcellerated T Cells in patients with chronic lymphocytic leukemia. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to adverse clinical results as our product candidates move into and advance in clinical trials, risks that the FDA may not agree with our proposals for design of the planned Phase II/III trial of Xcellerated T Cells in patients with chronic lymphocytic leukemia or our clinical or manufacturing plans and failure by Xcyte Therapies to secure or maintain relationships with collaborators. Results obtained in early stage clinical trials may not be predictive of results obtained in larger trials intended to demonstrate the safety and efficacy of Xcellerated T Cells. More information about the risks and uncertainties faced by Xcyte Therapies is contained in our filings with the Securities and Exchange Commission. Xcyte Therapies disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Xcyte Therapies, Inc. is a biotechnology company developing a new class of therapeutic products designed to enhance the body's natural immune responses to treat cancer, infectious diseases and other medical conditions associated with weakened immune systems. Xcyte derives its therapeutic products from a patient's own T cells, which are cells of the immune system that orchestrate immune responses and can detect and eliminate cancer cells and infected cells in the body. Xcyte uses its patented and proprietary Xcellerate(TM) Technology to generate activated T cells, called Xcellerated T Cells(TM), from blood that is collected from the patient. Activated T cells are T cells that have been stimulated to carry out immune functions. The Xcellerate(TM) Technology is designed to rapidly activate and expand the number of the patient's T cells outside of the body. Xcyte is currently conducting clinical trials of Xcellerated T Cells(TM) in patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and multiple myeloma.
Xcyte(TM), Xcyte Therapies(TM), Xcellerate(TM) and Xcellerated T Cells(TM) are trademarks of Xcyte Therapies, Inc. |
