Cell Thera temporarily halts PIONEER study enrollment

USA-based drug developer Cell Therapeutics says that recruitment in its PIONEER lung cancer trial, designed to assess its developmental anticancer agent Xyotax (paclitaxel poliglumex), has been suspended while it awaits follow-up data from recently-enrolled patients. The firm added that all patients currently involved in the program will continue with the treatment protocol.

Cell Therapeutics explained that, following consultation with the trial's steering committee and the data safety monitoring board, it has decided to carry out assessment of the different rates of early cycle deaths observed between study groups. The company went on to say that, while most of the observed deaths were attributable to disease progression, more complete data is required to fully analyze this difference.

The Seattle-headquartered firm also said that, in accordance with recommendations from the Food and Drug Administration, the company reviewed the demographic and estrogen-related data that had arisen so far and decided to make amendments to the trial during its suspension. Specifically, the assessment will be refocused to concentrate on measureing the efficacy of the agent in women with normal estrogen levels, the subgroup which demonstrated the greatest survival benefit in a previous study.