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European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
Date:4/1/2008

process for XYOTAX," said James A. Bianco, M.D., President and CEO of CTI. "This is an important step toward making XYOTAX available for lung cancer patients in Europe."

About Lung Cancer

Lung cancer is the most common malignancy worldwide. Non-small cell lung cancer (NSCLC) accounts for 80 percent of all lung cancer cases. Within the population of patients with NSCLC requiring chemotherapy, PS2 patients, which account for approximately 25 percent of this group, are a population with special requirements since they have poor survival with cytotoxic chemotherapy and targeted agents. PS2 patients represent a subgroup of patients who are ambulatory and capable of self-care, but are unable to carry out any work activities, although they are up and about more than 50 percent of waking hours. There are presently no drugs approved to treat PS2 patients with advanced NSCLC.

Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.

About XYOTAX(TM)

XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational, 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,
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SOURCE Cell Therapeutics, Inc.
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