CELL THERAPEUTICS TO AMEND PROTOCOL FOR LUNG CANCER STUDY

Cell Therapeutics announced it has agreed with the data safety monitoring board (DSMB) to close the PGT305 PIONEER lung cancer clinical trial and take patients off both treatment arms. The company's decision was due to its plans to submit a new protocol to the FDA and to the low rate of deaths in the control group. The company plans to submit a new protocol by the end of the year, under a Special Protocol Assessment. The new protocol will focus exclusively on women with normal estrogen levels, the subset where Xyotax has demonstrated the greatest survival advantage in the STELLAR trials.

The company had suspended the trial in November to allow maturity of the data and assessment of differences in early cycle deaths observed between arms of the study.

The PIONEER study was initiated in 2005 in 170 sites in North and South America, Europe and Asia. The trial was originally designed to enroll approximately 600 PS2 chemotherapy-naive women with advanced non-small-cell lung cancer. Each study arm will be randomized to receive either Xyotax (paclitaxel poliglumex) or paclitaxel once every three weeks. The primary endpoint is superior overall survival, with several secondary endpoints including disease control, response rate in patients with measurable disease, time to disease progression and disease-related symptoms.

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.