Fast-track for Cell Thera's Xyotax
Cell Therapeutics says that Xyotax (paclitaxel poliglumex), a novel biologically-enhanced version of one of the most used cancer drugs, Taxol (paclitaxel), qualifies for fast-track designation for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer.
The company recently filed a Special Protocol Assessment with the US Food and Drug Administration for the design of its Phase III trial of Xyotax for women with advanced NSCLC. The trial, PGT306, will focus exclusively on women with normal estrogen levels, the subset where the drug demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 PS2 women who have advanced NSCLC and have not received prior chemotherapy. Only women with normal estrogen levels, either as a result of pre-menopausal age or hormone replacement therapy, will be randomized in the trial.
CT's stock rallied nearly 13% to $1.83 on the news, which was released April 11.
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