January 12, 2007

Cell Therapeutics has filed for a special protocol assessment (SPA) with the FDA for the design of its Phase III trial of Xyotax for women with advanced lung cancer. The trial, PGT306, will focus exclusively on women with normal estrogen levels, the subset where Xyotax demonstrated the greatest survival advantage in the STELLAR trials.

The trial is expected to enroll 300 poor-performance-status women who have advanced-stage non-small-cell lung cancer (NSCLC) and have not received prior chemotherapy. Only women with normal estrogen levels either as a result of premenopausal age or hormone replacement therapy will be randomized in the follow-on study to the PIONEER trial.

Last month the company announced it agreed with the data safety monitoring board to end the PIONEER lung cancer clinical trial and take patients off both treatment arms. The company's decision was due to the low rate of deaths in the control group. The company had suspended the trial in November 2006 to assess the differences in early cycle deaths observed between arms of the study.

Xyotax is a biologically enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities, according to the company.