Cell Therapeutics, Inc. (CTI) to Submit Marketing Authorization Application for XYOTAX(TM) for First-line Non-small Cell Lung Cancer Ahead o...( European regulatory authori...)

European regulatory authorities support filing strategy

SEATTLE, Dec. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) reported today that it met with and received feedback from the rapporteur and co-rapporteur regarding its marketing authorization application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103). The feedback supports submission of the MAA in the first quarter of 2008, earlier than the first half of 2008 that CTI was targeting. The rapporteur and co-rapporteur, who are assigned by the EMEA, are responsible for providing scientific advice on the evaluation of medicinal products. CTI plans to submit an MAA in Europe, based on the STELLAR 4 phase III clinical trial results, for XYOTAX as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in patients with poor performance status (ECOG performance status 2, PS2).

"The meetings were very productive and we appreciate the advice the rapporteurs provided us on how best to report our data and supporting literature for the utility of the comparator drugs gemcitabine and vinorelbine," said Scott C. Stromatt, M.D., Executive Vice President, Clinical Development and Regulatory Affairs. "Based on their feedback and agreement on several critical components of the application, we believe we will be in a position to submit our MAA in the first quarter, months ahead of our previous target."

Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.

About PS2 NSC Lung Cancer

PS2 patients represent a subgroup of patients who are ambulatory and capable 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. PS2 non-small cell lung cancer (NSCLC) patients account for approximately 25 percent of all patients with NSCLC
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