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Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell Lung Cancer
Date:9/23/2007

Trial Lays Road Map for Potential Approval of XYOTAX(R) for Women with

Advanced Non-Small Cell Lung Cancer

SEATTLE, Sept. 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) said today it has begun a confirmatory phase III clinical trial of combination chemotherapy for women with advanced non-small cell lung cancer (NSCLC) -- the most lethal cancer facing women today. The trial, known as PGT307, will focus exclusively on women with pre-menopausal estrogen levels -- a group whose survival is significantly shorter than post-menopausal women. XYOTAX (TM) (paclitaxel poliglumex) will be studied in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1, or 2. Paclitaxel in combination with carboplatin is the most commonly used treatment for the estimated 200,000 Americans who are diagnosed with lung cancer each year. The company also announced it received special protocol assessment (SPA) approval from the U.S. Food and Drug Administration (FDA) on the design of the trial.

"In our STELLAR 3 trial we saw a survival benefit in the 70 percent of women who were pre-menopausal, where the XYOTAX/carboplatin combination increased the overall survival of this group by 34 percent over the control arm," said James A. Bianco, M.D., President and CEO of CTI. "This was the basis for PGT307, which can potentially show the important relationship between levels of estrogen and XYOTAX' effectiveness in lung cancer. Lung cancer remains the number one cancer killer of women -- we must ensure that this patient population has access to effective therapies as soon as possible. A successful PGT307 trial will also mean a step forward for gender medicine --a concept too long ignored by the medical establishment."

The PGT307 trial will enroll 450 patients. CTI plans to submit a marketing authorization application (MAA) in Europe in the first half of 2008 for X
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SOURCE Cell Therapeutics, Inc.
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