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Opaxio

Generic name: paclitaxel poliglumex
Treatment for: Non-Small Cell Lung Cancer, Ovarian Cancer, Glioblastoma Multiforme, Head and Neck Cancer

CTI and FDA Agree on NDA Filing Strategy for Xyotax

PIONEER Trial Interim Data to Provide Basis for Review Supported by Gender-Specific STELLAR Trial Results

SEATTLE, June 01, 2006 -- Cell Therapeutics, Inc. (CTI) announced that at a recent meeting with the U.S. Food and Drug Administration (FDA), CTI and the FDA agreed on a new drug application (NDA) route for Xyotax (paclitaxel poliglumex) for women with lung cancer. The FDA agreed to review an NDA submission based on interim results of the PIONEER trial with the results of the STELLAR 3 and 4 trials to support the filing. Based on this feedback, if the PIONEER trial meets its pre-specified interim endpoint, CTI plans to submit an NDA in the first half of 2007 and would request a priority (six month) review based on the fast track designation, instead of the standard (ten month) review as previously planned.

"We are happy with the outcome from our pre-NDA meeting with the FDA, which focused on how best to utilize the survival data observed among women in the STELLAR 3 and 4 trials and confirmatory data from our ongoing gender- specific PIONEER trial," stated James A. Bianco, M.D., President and CEO of CTI.

"By reviewing an NDA based on interim data from the PIONEER study, this approach could reduce the approval process for this novel therapeutic by more than 12 months over a filing based on full results of the PIONEER study."

"Lung cancer is a major unmet medical crisis for women and will kill 70,000 women this year. The biology of lung cancer is different in women and they appear to respond differently to treatment than men. We need to examine the potential for gender-specific therapy, not only in lung cancer but in a number of cancers that are known to express the estrogen receptor. Increasing knowledge of human biology is the ultimate promise of personalized medicine," Bianco added.

About the PIONEER clinical trial

The PIONEER clinical trial is targeting approximately 170 sites in the United States, Eastern Europe, and Latin America. 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/m(2) paclitaxel equivalents) or paclitaxel (at a dose of 175mg/m(2)) 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.

About Xyotax

Xyotax (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. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Based on preclinical studies, it appears that Xyotax is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. 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.

Posted: June 2006

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