Cell Therapeutics said it began a Phase III trial of Xyotax as a combination therapy specifically geared towards women with advanced, non-small cell lung cancer. The trial, which received special protocol assessment approval from the FDA on its design, will focus exclusively on women with pre-menopausal estrogen levels, who have significantly shorter survival than do post-menopausal women. "In our STELLAR 3 trial we saw a survival benefit in the 70 percent of women who were pre-menopausal, where the Xyotax/carboplatin combination increased the overall survival of this group by 34% over the control arm," said Cell Therapeutics CEO James A. Bianco. Xyotax, or paclitaxel poliglumex, will be studied in combination with carboplatin against paclitaxel/carboplatin, which is the most commonly used treatment for lung cancer. The trial, known as PGT307, will cover 450 patients. Based on the results, the company plans to submit a marketing authorization application in Europe in the first half of 2008. Shares are up 6.7% to $3.74 in early Monday trading.
Sources: Press release
Commentary: Cancer Stocks: Lagging Again • Cell Therapeutics: Mixed Shelf Registration News Sinks Stock
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