A confirmatory Phase III trial of Cell Therapeutics' polymer-linked paclitaxel Xyotax is recruiting women with advanced non-small cell lung cancer who have premenopausal estrogen levels (>30 pg/mL). The PGT307 trial, designed under a special protocol assessment with FDA, will enroll 450 women with NSCLC performance status 0, 1, or 2, who will be randomized to Xyotax (paclitaxel poliglumex) plus carboplatin or paclitaxel/carboplatin. CTI has been highlighting its plans for a normal estrogen level protocol to support a "gender medicine" NDA (1Pharmaceutical Approvals Monthly, December 2006, p. 11). An earlier gender-specific trial, the PIONEER study, enrolled women with both normal and abnormal estrogen levels, but was terminated late last year due to early cycle deaths in both arms. CTI has been trying to isolate the effect observed in women in its STELLAR pivotal program. The traditional gender-neutral program failed to meet endpoints in the total NSCLC population, but showed a benefit in women...

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...

Novartis has signed a licensing agreement with Cell Therapeutics that could potentially hasten to market the first gender-specific therapy for the treatment of non-small cell lung cancer