Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell L...(YOTAX as a single agent for first-line t...)

PGT307 Clinical Trial Protocol

The PGT307 clinical trial is recruiting women with advanced NSCLC who have pre-menopausal estrogen levels (>30pg/mL). The phase III trial is expected to enroll 450 patients. Each study arm of approximately 225 patients will be randomized to receive either XYOTAX 175mg/m2 plus carboplatin (AUC6) or paclitaxel 225mg/m2 plus carboplatin (AUC6) once every three weeks. Patients will be treated for up to six cycles. The primary endpoint is superior overall survival with several secondary endpoints including progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms.

"An analysis of recent Eastern Cooperate Oncology Group (ECOG) studies presented at the World Conference on Lung Cancer shows that women under 45 years old, presumably pre-menopausal, have worse outcomes than older women who are over 60," said Jack W. Singer, M.D., Chief Medical Officer at CTI. "This data, coupled with the recent Southwest Oncology Group (SWOG) analysis that also showed women under 60 had shorter survival, underscores the potential importance of the survival advantage we observed with XYOTAX in younger women on the STELLAR trials."

Singer added, "Preclinical studies show the influence of estrogen on the anti-tumor effect and metabolism of XYOTAX and provide the likely scientific basis for the clinical observation that women treated with XYOTAX, and in particular women with normal estrogen levels, had superior survival over women who were randomized to standard chemotherapy in the STELLAR clinical trials. Through our PGT307 study we hope to take a negative risk factor -- estrogen -- and turn it into one that potentially benefits patients."

Laurie Fenton Ambrose, President of the Lung Cance
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