Cell Therapeutics, Inc. Issues Statement On Study In Women With Lung Cancer

SEATTLE, July 13 /PRNewswire-FirstCall/ -- James A. Bianco, M.D., President and CEO of Cell Therapeutics, Inc. (CTI) today issued the following statement on the release of a study by the Journal of the American Medical Association which included the findings that women smokers are more at risk for lung cancer than men:

“The recent announcement of the higher susceptibility of women smokers to the dangers of lung cancer should remind lawmakers on Capitol Hill and the medical research community of the need to devote increased resources to finding new therapies for the number one cancer killer of women in the United States. The federal government spends in research $1,829 per lung cancer death, compared to $23,474 per breast cancer death. Lung cancer research needs to take gender into account. Women are affected differently from men when lung cancer strikes, as shown by this study, and women respond differently to treatment. We need to better understand that biological difference to develop more effective therapies for women,” Bianco concluded.

CTI is currently conducting a phase III clinical trial exclusively for women with advanced non-small cell lung cancer.

About the PIONEER Clinical Trial

The PIONEER clinical trial is targeting approximately 170 sites in North and South America, Europe, and Asia. CTI expects to enroll approximately 600 PS2 chemotherapy-naive women with advanced stage NSCLC. Each study arm of approximately 300 patients will be randomized to receive either XYOTAX (at a dose of 175mg/m2 paclitaxel equivalents) or paclitaxel (at a dose of 175mg/m2) once every three weeks. The primary endpoint is superior overall survival with several secondary endpoints including disease control, response rate in patients with measurable disease, time to disease progression, and disease-related symptoms. For more information on the PIONEER trial, call 1-800-715-0944.

About XYOTAX

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.

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 www.cticseattle.com.

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. Pursuant to U.S. 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.

Cell Therapeutics, Inc.

CONTACT: media, Dan Eramian, +1-206-272-4343, or Susan Callahan,+1-206-272-4472, or fax, +1-206-272-4434, or media@ctiseattle.com, orwww.cticseattle.com/media.htm, or investors, Leah Grant, +1-206-282-7100,or fax, +1-206-272-4434, or invest@ctiseattle.com, orwww.cticseattle.com/investors.htm, all of Cell Therapeutics, Inc.

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