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New Pixantrone Data Presented at Meetings at American Society of Hematology Conference
Date:12/6/2010

once the survival and PFS data are mature. The summary update presented at ASH meeting is available for viewing on the Company's website www.celltherapeutics.com.

About the PIX301 EXTEND trial: PIX301 is the largest and only randomized trial comparing single agent pixantrone to a list of physician's choice of standard chemotherapy to patients with relapsed or refractory aggressive NHL who have failed two or more lines of therapy. There are currently no approved or effective agents for these patients. The successful PIX301 study results formed the basis of the Company's recent MAA submission to the EMA which was validated and accepted for review on November 17th, 2010.

In addition on December 2, 2010 the Company filed a formal appeal with the U.S. Food and Drug Administration (the "FDA") under the FDA's dispute resolution proceedings. The basis for the appeal is based on the Company's belief that the FDA diverged from accepted statistical principles and practices when the FDA applied a more stringent statistical significance level in concluding that the PIX301 primary analysis required an adjustment for type 1 error as if an interim analysis had been conducted. This was not the case in the PIX301 trial where only a single final analysis was undertaken. The Company expects to have a response to the appeal in the first quarter of 2011.

About PIX203 trial design: The PIX203 trial is a first-line randomized phase II study of the CHOP-R versus CPOP-R in high risk and elderly patients with previously untreated DLBCL  The study evaluates replacing doxorubicin in the standard CHOP-R combination regimen with pixantrone as part of the CPOP-R regimen. The objective of the study was to demonstrate non-inferior complete response rates to standard doxorubicin-based therapy while producing significantly less severe acute and chronic cardiac toxicities. The Company plans to submit the results of this study for
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SOURCE Cell Therapeutics, Inc.
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3. Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval
4. Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkins Lymphoma
5. Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
6. Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009
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