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Business Summary and Article:CTIC
Free Level 2 Stock Quotes Business Summary: CTIC
Cell Therapeutics, Inc. markets lymphoma drug, Zevalin, in the United States. Zevalin is an FDA-approved radioimmunotherapeutic for treating lymphoma. The company also develops, acquires, and commercializes novel treatments for cancer.

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Cell Therapeutics, Inc., incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company’s research, development, acquisition and in-licensing activities concentrate on identifying and developing new, less toxic and effective ways to treat cancer. It is developing paclitaxel poliglumex, which the Company has previously referred to as XYOTAX, for the treatment of non-small cell lung cancer (NSCLC), and ovarian cancer. Cell Therapeutics, Inc. is also developing paclitaxel poliglumex as potential maintenance therapy for women with advanced stage ovarian cancer who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. The Company is developing pixantrone, an anthracycline derivative, for the treatment of non-Hodgkin’s lymphoma (NHL). An interim analysis of its ongoing phase III study of pixantrone, known as the EXTEND or PIX301 study, was performed by the independent Data Monitoring Committee during the year ended December 31, 2006. Cell Therapeutics, Inc. is developing Zevalin for additional indications. 

On December 21, 2007, the Company completed its acquisition of the United States development, sales and marketing rights to the radiopharmaceutical product Zevalin (Ibritumomab Tiuxetan) (Zevalin) from Biogen Idec Inc. (Biogen), pursuant to an Asset Purchase Agreement. Zevalin was the first radioimmunotherapy approved by the United States Food and Drug Administration (FDA). It was approved to treat patients with relapsed or refractory low-grade, follicular, or B-cell non-Hodgkin’s lymphoma (NHL). On July 31, 2007, the Company completed its acquisition of Systems Medicine, Inc. (SM), which is a privately held oncology company. 

Paclitaxel Poliglumex
Paclitaxel poliglumex is a chemotherapeutic agent, which links a used anti cancer agent, paclitaxel, to a polyglutamate polymer for the potential treatment of NSCLC and ovarian and other cancers. Paclitaxel poliglumex utilizes a biodegradable polymer to deliver the chemotherapeutic agent paclitaxel preferentially to tumor tissue. By linking paclitaxel to a biodegradable amino acid carrier, the conjugated chemotherapeutic agent is inactive in the bloodstream, sparing normal tissues the toxic side effects of chemotherapy. The chemotherapeutic agent is activated and released once inside tumor tissue by the action of an enzyme called cathepsin B. The activity of this enzyme and thus the rate of release of XYOTAX is increased in the presence of estrogen. More than 1,900 patients were treated in the Company’s four pivotal phase III trials of Paclitaxel poliglumex for the treatment of NSCLC. 

In February 2006, the Company presented results that confirm the observation of efficacy in the presence of estrogen seen in the STELLAR first-line trials. In the three first-line trials of paclitaxel poliglumex (PGT202, STELLAR 3 and STELLAR 4), women of pre-menopausal age or with normal estrogen levels had the survival advantage over their counterparts. In an analysis of the 113 of 198 women in the pooled STELLAR 3 and 4 trial data who are of pre-menopausal age or normal estrogen level, women treated with paclitaxel poliglumex had a prolongation in the 1-year and overall survival estimates compared to women treated with standard chemotherapy, with the paclitaxel poliglumex patients having a 44% reduction in the overall risk of dying and a 43% 1-year survival estimate compared to 19% for women on standard chemotherapy. 

Cell Therapeutics, Inc.’s phase III trials demonstrated that single agent paclitaxel poliglumex has a reduced incidence of severe side effects, including a reduction in severe neutropenia, febrile neutropenia, infection and anemia, when compared to patients receiving standard chemotherapy agents gemcitabine, vinorelbine or docetaxel. Paclitaxel poliglumex also resulted in less severe allergic reactions, hair loss and requirements for growth factor support (Neupogen, Neulasta, Aranesp and/or Epogen) than patients receiving standard chemotherapy. 

In December 2006, in agreement with the Data Safety Monitoring Board, it closed the PIONEER lung cancer clinical trial. During the year ended December 31, 2007, the Company submitted two new protocols under an special protocol assessment (SPA) to the FDA. The new trials, known as PGT306 and PGT307, focus exclusively on NSCLC in women with pre-menopausal estrogen levels, the subset of patients where paclitaxel poliglumex demonstrated the greatest potential survival advantage in the STELLAR trials. The Company has initiated the PGT307 trial in September 2007, but has not initiated the PGT306 trial. In 2008, Cell Therapeutics, Inc. limited enrollment on the PGT307 study to the United State sites only, until either approval of an marketing authorization application (MAA) for paclitaxel poliglumex by the Europeam medicines agency (EMEA) or until positive results from the GOG212 trial of paclitaxel poliglumex for first-line maintenance therapy in ovarian cancer are reported.

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