CELL THERAPEUTICS SUSPENDS ENROLLMENT IN LUNG CANCER TRIAL

Cell Therapeutics announced that enrollment in its PIONEER lung cancer clinical trial has been temporarily suspended while the company awaits follow-up data of recently enrolled patients. After consultation with the company and the study's steering committee, the data safety monitoring board (DSMB) recommended and the company agreed to suspend enrollment on the trial to allow maturity of the data and assessment of differences in early cycle deaths observed between arms of the study. While most of the deaths were attributed to disease progression, more complete data is required. Also, according to the recommendation of the DSMB, all patients who are currently on the trial will continue to be treated per the protocol.

In addition, as a planned follow-up to its May meeting with the FDA, the company reviewed the demographic and estrogen data of the patients on the PIONEER study and plans to amend the current study while enrollment is suspended. The study will be amended to focus on the primary efficacy endpoint of survival in women with normal estrogen levels -- the subset of patients that demonstrated the greatest survival benefit in the STELLAR trials.

The PIONEER study was initiated in 2005 using premenopausal age to stratify patients. Based on feedback from the FDA, the company will follow the agency's recommendation to amend the protocol to use estrogen level as a stratification factor and as the primary efficacy endpoint of the study. The company expects to submit an amendment to the FDA under a special protocol assessment request. The company anticipates the change to the protocol will push the interim analysis of the PIONEER trial back by at least six months.

The PIONEER trial is targeting approximately 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.