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FDA Law Weekly

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Cell Therapeutics, Inc.



Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial



November 20th, 2008

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that it has closed the data set for preliminary analysis of the primary endpoint in the phase III EXTEND (PIX301) trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL) and it has provided Novartis notice that the data set has been closed. The primary endpoint for the study is the complete remission (CR) and unconfirmed complete remission (uCR) rate in patients receiving either pixantrone or another single agent chemotherapeutic drug. CTI plans to report top-line results in November.

"We are excited to have reached the end of the treatment phase and...


Source: FDA Law Weekly (2008-11-20)

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