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Cell Therapeutics, Inc. (CTI) to Submit Marketing Authorization Application for XYOTAX(TM) for First-line Non-small Cell Lung Cancer Ahead of Schedule
Date:12/18/2007

who require chemotherapy. There are presently no drugs approved to treat PS2 patients with advanced NSCLC. Current treatments for this group of patients are poorly tolerated, with most tolerating a median of two doses of chemotherapy and experiencing disease progression on average within six weeks. Most physicians will utilize single-agent gemcitabine or vinorelbine to treat these frail patients. Current treatments also have limited effectiveness, with median survival ranging from only ten weeks for single-agent treatment to just over 17 weeks for combination therapies.

About the STELLAR 4 Trial

The STELLAR 4 phase III clinical trial tested XYOTAX versus either gemcitabine or vinorelbine for the potential first-line treatment of poor performance status (PS2) patients with NSCLC. While the STELLAR 4 trial missed its primary endpoints of significant improvement in overall survival, it did demonstrate significant reductions in many of the clinically relevant toxicities associated with gemcitabine or vinorelbine. Based on the clinical benefit of lower severe toxicities, reduced use of hematopoietic growth factors and transfusions, enhanced convenience, and reduced medical resource utilization and associated costs, in 2006 CTI received a positive opinion from the Scientific Advice Working Party (SAWP) of the EMEA that a switch from the superiority endpoint to a non-inferiority endpoint is feasible if adequate justification is provided in the marketing application.

About XYOTAX(TM)

XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unl
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SOURCE Cell Therapeutics, Inc.
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