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Independent Radiology Assessment Panel Results Confirm Statistical Significance of Response and Progression Endpoints of Cell Therapeutics' Pixantrone PIX301 Pivotal Trial
Date:9/27/2011

SEATTLE, Sept. 28, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that a second independent radiology assessment of response and progression endpoint data from CTI's PIX301 clinical trial of pixantrone confirmed the statistical robustness of the PIX301 efficacy data that was previously submitted by CTI to the U.S. Food and Drug Administration ("FDA") in CTI's new drug application ("NDA") for pixantrone.

This second independent assessment was recommended by the FDA's Office of New Drugs ("OND") as part of CTI's appeal of the Complete Response Letter ("CRL") for the NDA, which CTI received from the FDA's Office of Oncology Drug Products.

"The review conducted by a second independent panel of three radiologists confirmed the statistically and clinically significant results the first independent panel reported for the PIX301 study response and progression endpoints," noted James A. Bianco, M.D., CEO of CTI. "We now have two separate independent response assessment panels reporting significant results for complete response/complete response unconfirmed, overall response rate and progression-free survival at both end of treatment and end of study assessment periods as well as among the histologically confirmed aggressive non-Hodgkin's lymphoma ("NHL") subset of patients. We look forward to sharing these confirmatory results with the Division of Oncology Drug Products ("DODP") in our resubmission of the pixantrone NDA."

The review and the review process was conducted based on the recommendations by OND in order to determine that efficacy had been established by confirming confidence in the endpoint ascertainment and reliability of the primary results.

Based on the results of this second independent assessment panel's review, CTI plans on resubmitting the pixantrone NDA as early as October 2011 for accelerated approval.  The DODP previously confirmed that the review of the NDA would be complet
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SOURCE Cell Therapeutics, Inc.
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