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European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.'s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application
Date:7/6/2009

SEATTLE, July 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it had requested and the EMEA has agreed to an oral explanation in support of the OPAXIO Marketing Authorization Application (MAA) in September, 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on approval until Q4-2009. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile. The previously scheduled June, 2009 meeting with the EMEA on OPAXIO did not occur due to conflicts in regulatory schedule as CTI focused on completing the pixantrone New Drug Application (NDA) submission in June, 2009.

"We are pleased that the EMEA has agreed to an in person oral explanation in September allowing the Company and its lung cancer experts adequate time to prepare a thorough review for the Co-rapporteurs in support of our MAA for OPAXIO in non-small cell lung cancer," said James A. Bianco, M.D., CEO of Cell Therapeutics. "The fourth quarter is shaping up to be a pivotal period for the Company."

About OPAXIO(TM)

OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), 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, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors du
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SOURCE Cell Therapeutics, Inc.
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