Guest guest Posted March 23, 2005 Report Share Posted March 23, 2005 [it looks as though the company is trying to reduce the 'burn' rate of its funds. It is dropping multiple myeloma and NHL trials, which is unfortunate for those patients, let alone the company. In addition, it is shedding employees. Not the mark of a thriving company, unfortunately. Although the results from the trials so far have shown improvement in some aspects of patient's CLL, I think we all were hoping for more. Still, reductions in node size, coupled with a trial in patients who have been treated with Campath, may produce better results. (Though I think that co-treatment may be a better idea, since Campath seems to work well on serum/bone marrow, but not on bulky nodes, but what do I know?)] Xcyte Therapies, Inc. Updates Clinical Development Plans Wednesday March 23, 4:05 pm ET SEATTLE--(BUSINESS WIRE)--March 23, 2005--Xcyte Therapies, Inc. (Xcyte, the " Company " ) (Nasdaq:XCYT - News) announced today that the Company has recently completed a comprehensive review of its clinical development program. As a result of this review, the Company has decided to focus its resources and activities in two clinical areas. " We are excited about our results in several diseases, " said Ron Berenson, M.D., President and Chief Executive Officer of Xcyte Therapies. " However, we recognize that we need to focus our resources on our best opportunities. Therefore, we intend to concentrate our efforts on our planned Phase II/III trial in chronic lymphocytic leukemia (CLL). We also intend to initiate a Phase I/II trial in patients with HIV late this year. We will complete our ongoing trials in patients with multiple myeloma and non-Hodgkin's lymphoma, but will not initiate additional trials in these indications at this time. Our goal is to maintain our operating expenses for 2005 in approximately the same range as for 2004, while retaining the core competencies needed to move into a later stage trial. " In the Company's Phase I/II CLL trial, 12 of 17 (71%) who received a single infusion of Xcellerated T Cells demonstrated a 50% or greater decrease in the size of their enlarged lymph nodes. Eleven (85%) of the 13 patients with an enlarged spleen demonstrated a 50% or greater decrease in the size of their spleen. Based on these results, Xcyte is planning to initiate a Phase II/III trial, named the X-CLL Trial, in patients who have previously been treated with Campath. Following an End of Phase II meeting with the FDA in September 2004, Xcyte submitted a final protocol for this trial to the FDA in December 2004. In February 2005, the FDA requested that the Company withdraw this protocol to facilitate further discussion of the design of the trial. The protocol was resubmitted as a draft protocol in mid- February, and the Company has continued an extensive discussion with the FDA since that time. Also in mid-February, the Company met with the FDA to discuss the chemistry, manufacturing and controls submission that has been made related to this trial and our planned transfer of our manufacturing operations to our new facility in Bothell, Washington. " We are working with the FDA to resolve the remaining issues in the design of this Phase II/III trial as rapidly as possible, " continued Dr. Berenson. " It remains our highest priority to get this trial underway as quickly as possible. " As a result of the plan to focus clinical development on the Phase II/III trial in CLL and a Phase I/II trial in HIV, Xcyte yesterday reduced its workforce by approximately 24% to approximately 81 employees. The Company believes that remaining staff will be sufficient to initiate the two planned clinical trials and to transfer manufacturing operations for the Phase II/III trial to our new facility. The total cost to the Company of the termination benefits are expected to be approximately $300,000. Quote Link to comment Share on other sites More sharing options...
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