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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: Extra Pale who wrote (736)	9/27/2005 11:12:33 AM
From: tuck	Read Replies (3) \| Respond to of 946

Fuller analysis of the STELLAR trials showing the benefit to women are presented at UBS conference today. Effect of estrogen on metabolism of XYOTAX being studied: >>NEW YORK, Sept. 27 /PRNewswire-FirstCall/ -- At a presentation at the UBS Global Life Sciences Conference, Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX: CTIC) presented new results from a recently completed phase II clinical trial of XYOTAX in the first-line treatment of men and women with advanced non-small cell lung cancer (NSCLC). In that single arm study, known as PGT202, the 35 women who received XYOTAX plus carboplatin had a 36 percent probability of living at least 1 year compared to only 16 percent in the 39 men receiving the same regimen. A pooled analysis of XYOTAX treated patients from STELLAR 3, STELLAR 4 and the PGT202 trial demonstrated a statistically significant (p=0.004) survival advantage for women treated when compared to men, with women having a 39 percent probability of surviving at least 1 year compared to 25 percent of men (HR =1.37, log rank p = 0.014 N = 463 patients). The Company previously reported that in a combined analysis of STELLAR 3 and 4, women treated with XYOTAX survived significantly longer than women treated on the standard chemotherapy control arms of these studies. "To the best of our knowledge this is the first time a drug therapy for advanced lung cancer has consistently demonstrated such a strong survival advantage for women compared to men or compared to women randomized to treatment with standard chemotherapy," noted Jack W. Singer, M.D., Chief Medical Officer at CTI. "We are currently evaluating the effect of estrogen on the metabolism of XYOTAX in normal and cancerous tissues to provide mechanistic support for these important clinical results." In August, CTI outlined its plans to file a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe in 2006 based on the results of its Stellar 3 and 4 trials.<< snip Stock is back over $3 bucks. Hoping good Pix results are next. Any statisticians here want to throw cold water on the pooled subset analysis? Cheers, Tuck