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Gender-Specific Phase III Trial for Advanced Non-Small Cell


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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

Trial Lays Road Map for Potential Approval of XYOTAX® for Women with Advanced Non-Small Cell Lung Cancer

September 24, 2007: 01:30 AM EST

SEATTLE, Sept. 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) 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 (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 XYOTAX as a single agent for first-line treatment of NSCLC in performance status 2 (PS2) patients based on results from its STELLAR 4 randomized phase III trial.

PGT307 Clinical Trial Protocol

The PGT307 clinical trial is recruiting women with advanced NSCLC who have pre-menopausal estrogen levels (>30pg/mL). The phase III trial is expected to enroll 450 patients. Each study arm of approximately 225 patients will be randomized to receive either XYOTAX 175mg/m2 plus carboplatin (AUC6) or paclitaxel 225mg/m2 plus carboplatin (AUC6) once every three weeks. Patients will be treated for up to six cycles. The primary endpoint is superior overall survival with several secondary endpoints including progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms.

"An analysis of recent Eastern Cooperate Oncology Group (ECOG) studies presented at the World Conference on Lung Cancer shows that women under 45 years old, presumably pre-menopausal, have worse outcomes than older women who are over 60," said Jack W. Singer, M.D., Chief Medical Officer at CTI. "This data, coupled with the recent Southwest Oncology Group (SWOG) analysis that also showed women under 60 had shorter survival, underscores the potential importance of the survival advantage we observed with XYOTAX in younger women on the STELLAR trials."

Singer added, "Preclinical studies show the influence of estrogen on the anti-tumor effect and metabolism of XYOTAX and provide the likely scientific basis for the clinical observation that women treated with XYOTAX, and in particular women with normal estrogen levels, had superior survival over women who were randomized to standard chemotherapy in the STELLAR clinical trials. Through our PGT307 study we hope to take a negative risk factor -- estrogen -- and turn it into one that potentially benefits patients."

Laurie Fenton Ambrose, President of the Lung Cancer Alliance, noted, "We are excited to learn that CTI is moving forward on a new clinical trial for women with lung cancer. This is exactly the kind of research we need to help us better understand not only lung cancer's genetic differences, but to provide patients with improved treatment options." The Lung Cancer Alliance is a national non-profit organization dedicated solely to patient support and advocacy for people living with lung cancer or those at risk for the disease.

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