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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(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 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.


XYOTAX(TM) (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies. XYOTAX is being studied in non-small cell lung and ovarian cancers as well as in several investigator-sponsored trials for prostate and breast cancers.

Women and Lung Cancer

Lung cancer is the number one cancer killer of women in the United States -- more than breast and ovarian cancers combined. The American Cancer Society estimates that in 2007 there will be about 213,380 new cases of lung cancer in the United States -- up 22 percent from 2006. Of those new cases, 98,620 will be among women -- up 20 percent from a year ago. One in 16 women will develop lung cancer in their lifetime.

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

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of XYOTAX include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the potential failure of XYOTAX to prove safe and effective for treatment of non-small cell lung cancer, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

Susan Callahan

T: 206.272.4472

F: 206.272.4434


Investors Contact:

Leah Grant

T: 206.282.7100

F: 206.272.4434


Medical Information Contact:

T: 800.715.0944


SOURCE Cell Therapeutics, Inc.
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