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Positive Opinion From Pediatric Committee of European Medicines Evaluation Agency Paves Way for Cell Therapeutics, Inc. (CTIC)'s Pixuvri(R) Marketing Authorization Application Submission


10/19/2010 6:50:37 AM

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SEATTLE, Oct. 19 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the Pediatric Committee (the "PDCO") of the European Medicines Agency ("EMA") has adopted an opinion agreeing to CTI's Pixuvri® (pixantrone dimaleate) Pediatric Investigation Plan ("PIP") for the treatment of lymphoid malignancies and solid tumors in children between ages of 6 months and 18 years. This positive opinion clears the way for CTI to submit its Marketing Authorization Application ("MAA") in the E.U. later this quarter for pixantrone for the treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").

CTI submitted the updated PIP to the PDCO in July 2010 after the PDCO recommended CTI expand the original PIP to include pixantrone's potential clinical benefit of reducing long-term cardiotoxicity associated with current curative therapies in children. The expanded PIP was accepted for review by the PDCO in August 2010. The recommendation from the PDCO came following discussions with CTI about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancers and solid tumors. The PDCO also recommended deferral of the initiation of the clinical studies until after the drug receives EMA approval. The Company expects the EMA's decision on adoption of the PDCO's recommendations later this quarter.

Pixantrone was granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL).

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines--rather than intercalation with DNA--pixantrone alkylates DNA--forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production--both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com/.

Sign up for email alerts and get RSS feeds at CTI's Web site, http://www.CellTherapeutics.com/investors_alert

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective and/or less toxic and effective for the treatment of relapsed or refractory, aggressive NHL and/or other tumors as determined by the EMA, that CTI may not submit the MAA later this quarter, that the EMA may not make a decision on the adoption of the PDCO's recommendations later this quarter, that CTI's MAA may not be approved by the EMA by next year, that the current plans for the pediatric program may change, that the pediatric program may not determine the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers, that pixantrone may not reduce long-term cardiotoxicity associated with current curative therapies in children and CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

E: deramian@ctiseattle.com

www.CellTherapeutics.com/press_room


Investors Contact:

Ed Bell

T: 206.282.7100

Lindsey Jesch Logan

T: 206.272.4347

F: 206.272.4434

E: invest@ctiseattle.com

www.CellTherapeutics.com/investors


Medical Information Contact:

T: 800.715.0944

E: info@askarm.com



SOURCE Cell Therapeutics, Inc.


Read at BioSpace.com


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