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New Drug Application Will Be Submitted for Paclitaxel Poliglumex as First-Line Monotherapy for Women With Advanced Non-Small Cell Lung Cancer

SEATTLE, Aug. 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) announced that it has decided on its strategy for seeking registration and approval for Xyotax. In the United States, CTI plans to submit a New Drug Application (NDA) and seek approval for Xyotax as first-line monotherapy for women with advanced non-small cell lung cancer (NSCLC) who have poor performance status (PS2). The filing in Europe will also seek use as monotherapy in first-line PS2 patients with NSCLC, but is not expected to be limited to women; however, additional input on the statistical interpretation of non-inferiority will be needed from the scientific committee of the European Medicines Agency (EMEA) prior to submitting a Marketing Authorization Application (MAA).

"We believe that the survival data demonstrated among women in the STELLAR 3 and 4 trials are important enough to warrant review and consideration for approval. Based on our discussions with FDA, accelerated review and non- inferiority are not possible routes to pursue in the United States. We believe that a standard review based on the gender specific survival advantage observed in women in the STELLAR 3 and 4 trials is the most appropriate registration strategy in the US," stated Jack W. Singer, M.D., Chief Medical Officer of CTI. "While having missed the primary endpoints will make for a challenging review with the agencies, we are committed to conducting a study to try to confirm the survival advantage seen in women who received Xyotax in the STELLAR 3 and 4 studies and plan to initiate such a clinical study in the fourth quarter of 2005. This would be the first submission exclusively targeting survival in women with lung cancer."

About Lung Cancer
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women and results in more deaths per year than colorectal, breast, prostate, liver, and kidney cancers combined. Nearly 60 percent of people with lung cancer die within one year of their diagnosis and nearly 75 percent die within 2 years; figures which have not improved in 10 years. Lung cancer is expected to kill nearly twice as many women as breast cancer this year.

About Xyotax
Xyotax (paclitaxel poliglumex) is a pharmaceutical that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. 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 trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor.

Source: Cell Therapeutics

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