SEATTLE, Dec. 18 Cell Therapeutics, Inc. (CTI)(Nasdaq and MTAX: CTIC) reported today that it met with and received feedbackfrom the rapporteur and co-rapporteur regarding its marketing authorizationapplication (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103). Thefeedback supports submission of the MAA in the first quarter of 2008, earlierthan the first half of 2008 that CTI was targeting. The rapporteur andco-rapporteur, who are assigned by the EMEA, are responsible for providingscientific advice on the evaluation of medicinal products. CTI plans to submitan MAA in Europe, based on the STELLAR 4 phase III clinical trial results, forXYOTAX as a single agent for first-line treatment of non-small cell lungcancer (NSCLC) in patients with poor performance status (ECOG performancestatus 2, PS2).
"The meetings were very productive and we appreciate the advice therapporteurs provided us on how best to report our data and supportingliterature for the utility of the comparator drugs gemcitabine andvinorelbine," said Scott C. Stromatt, M.D., Executive Vice President, ClinicalDevelopment and Regulatory Affairs. "Based on their feedback and agreement onseveral critical components of the application, we believe we will be in aposition to submit our MAA in the first quarter, months ahead of our previoustarget."
Lung cancer remains the biggest cancer killer in Europe. The incidence oflung cancer in Europe is more than 13 percent of all cancers, and in 2000resulted in nearly 350,000 deaths.
About PS2 NSC Lung Cancer
PS2 patients represent a subgroup of patients who are ambulatory andcapable of self-care, but are unable to carry out any work activities,although they are up and about more than 50 percent of waking hours. PS2non-small cell lung cancer (NSCLC) patients account for approximately 25percent of all patients with NSCLC who require chemotherapy. There arepresently no drugs approved to treat PS2 patients with advanced NSCLC. Currenttreatments for this group of patients are poorly tolerated, with mosttolerating a median of two doses of chemotherapy and experiencing diseaseprogression on average within six weeks. Most physicians will utilizesingle-agent gemcitabine or vinorelbine to treat these frail patients. Currenttreatments also have limited effectiveness, with median survival ranging fromonly ten weeks for single-agent treatment to just over 17 weeks forcombination therapies.
About the STELLAR 4 Trial
The STELLAR 4 phase III clinical trial tested XYOTAX versus eithergemcitabine or vinorelbine for the potential first-line treatment of poorperformance status (PS2) patients with NSCLC. While the STELLAR 4 trial missedits primary endpoints of significant improvement in overall survival, it diddemonstrate significant reductions in many of the clinically relevanttoxicities associated with gemcitabine or vinorelbine. Based on the clinicalbenefit of lower severe toxicities, reduced use of hematopoietic growthfactors and transfusions, enhanced convenience, and reduced medical resourceutilization and associated costs, in 2006 CTI received a positive opinion fromthe Scientific Advice Working Party (SAWP) of the EMEA that a switch from thesuperiority endpoint to a non-inferiority endpoint is feasible if adequatejustification is provided in the marketing application.
XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational,biologically enhanced, chemotherapeutic that links paclitaxel, the activeingredient in Taxol(R), to a biodegradable polyglutamate polymer, whichresults in a new chemical entity. When bound to the polymer, the chemotherapyis rendered inactive, potentially sparing normal tissue's exposure to highlevels of unbound, active chemotherapy and its associated toxicities. Bloodvessels in tumor tissue, unlike blood vessels in normal tissue, are porous tomolecules like polyglutamat