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Cell Therapeutics Announces that the European Organization for Research and Treatment of Cancer Completes Enrollment in Phase II Clinical Trial of Brostallicin as First Line Therapy for Advanced or Metastatic Soft Tissue Sarcoma
Date:8/11/2008

Potential for data analysis early 2009

SEATTLE, Aug. 12 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc.'s (CTI) (Nasdaq: CTIC; MTA) subsidiary Systems Medicine (SM) announced today that planned enrollment is complete in the European Organization for Research and Treatment of Cancer (EORTC) randomized phase II clinical trial of brostallicin in patients with newly diagnosed advanced or metastatic soft tissue sarcoma who have had no prior chemotherapy. The primary endpoint of the trial is progression-free survival at six months. Patients are randomized in a 2:1 ratio either to receive brostallicin or the standard therapy, doxorubicin. The EORTC designed the study to enroll a total of 108 eligible and treated (evaluable) patients, and plans to conduct the final data analysis in early 2009.

"New therapies are needed to improve outcomes in patients with advanced non-GIST soft tissue sarcomas. This study is the second EORTC study of brostallicin in soft tissue sarcoma. The initial study used brostallicin as single agent salvage therapy in patients whose disease had progressed following initial chemotherapy. The EORTC considered the results in that trial to be of sufficient magnitude to conduct the current study, using brostallicin as first line therapy in patients with advanced or metastatic soft tissue sarcoma who have not received any prior chemotherapy," said Jack Singer, M.D., EVP, Chief Medical Officer of Cell Therapeutics. "A standard-of-care arm (doxorubicin) is included as a reference arm, although not used to determine comparative efficacy. If the study results are encouraging, a Phase III study in soft tissue sarcoma could be initiated in 2009."

The title of the trial is "Randomized phase II study
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SOURCE Cell Therapeutics, Inc.
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