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Discussions With FDA on Pixantrone EXTEND (PIX301) Trial Provide Path for NDA Submission
Date:9/5/2007

Food and Drug Administration (FDA) and pixantrone has received fast track designation for this indication.

About RAPID (PIX203)

The RAPID trial is a first-line randomized phase II study of the CHOP-R versus CPOP-R in previously untreated aggressive NHL patients. The study is evaluating replacing doxorubicin in the standard CHOP-R combination regimen (cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab) with pixantrone to part of the CPOP-R regimen (cyclophosphamide, pixantrone, vincristine, prednisone and rituximab). The objective of the study is to demonstrate non-inferior complete response rates as the standard doxorubicin-based therapy with significantly less severe cardiac toxicities and other doxorubicin-related toxicities on the CPOP-R arm of the study. 280 patients are expected to be enrolled.

About Pixantrone

Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to the currently marketed anthracyclines.

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.cticseattle.com. This press release includes forward-looking statements that involve a number of risks and
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SOURCE Cell Therapeutics, Inc.
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