CTI seeks Xyotax SPA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Seattle-based Cell Therapeutics is requesting a special protocol assessment for its revised Phase III Xyotax (paclitaxel poliglumex) trial, the company announced Jan. 10. CTI closed its Xyotax PIONEER study last month because the drug did not meet its primary endpoint in the overall patient population (1Pharmaceutical Approvals Monthly December 2006, p. 11). The new protocol (PGT306) will examine the investigational oncologic in the population that showed the most benefit - women with normal estrogen levels. CTI expects to enroll 300 patients who are either pre-menopausal or on hormone replacement therapy. Registration data are expected in the second quarter of 2008...