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Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval
Date:10/24/2011

SEATTLE, Oct. 25, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that it has resubmitted the pixantrone New Drug Application ("NDA") to the U.S. Food and Drug Administration's ("FDA") Division of Oncology Drug Products ("DODP") for accelerated approval to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.

CTI had appealed the FDA's Complete Response Letter for the pixantrone NDA based on the results of the PIX301 clinical trial. In May 2011, the FDA's Office of New Drugs ("OND") responded to CTI's appeal recommending that CTI conduct an additional review of radiographs utilizing a new independent panel of radiologists to confirm the response and progression events noted in the pixantrone NDA in order to determine that efficacy had been established.  CTI recently announced that a second independent radiology assessment of response and progression endpoint data confirmed the statistical robustness of the PIX301 efficacy data contained in the NDA.

In June 2011, CTI met with the DODP to review its plans for responding to the items noted in the Complete Response Letter ("CRL"), as well as its plans for addressing the items noted by the OND in response to the appeal. The Company believes the information contained within the resubmitted NDA adequately addresses the recommendations from the OND and items noted in the CRL.

"We believe the resubmitted NDA not only addresses the items in the Complete Response Letter, but confirms the reliability of the initial efficacy results, which we believe demonstrates that pixantrone does provide a clinical benefit to this patient population for which there are no currently approved therapies," said James A. Bianco, M.D., CEO of CTI.

The DODP previously confirmed that the review of the NDA would be completed within six months from the date of resubmission, which should provide C
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SOURCE Cell Therapeutics, Inc.
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