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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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