CELL THERAPEUTICS FILES FOR SPA FOR LUNG CANCER TRIAL

Cell Therapeutics announced it will file for a special protocol assessment (SPA) with the FDA for the design of a Phase III trial of a combination therapy for women with advanced lung cancer.

The trial, known as PGT307, will focus on women with normal estrogen levels and will study Xyotax (paclitaxel poliglumex) in combination with carboplatin versus paclitaxel plus carboplatin in female non-small-cell lung cancer (NSCLC) patients with performance status of 0, 1 or 2. The enrollment target is 450 patients with an interim analysis planned in the first half of 2008.

"The basis for this trial is the survival benefit we saw among premenopausal women in our STELLAR 3 trial, where the Xyotax/carboplatin combination increased the median survival rate of this group by 34 percent over the control arm," President and CEO James Bianco said.

Previously the company filed for an SPA for the PGT306 Phase III trial of Xyotax in NSCLC.

Xyotax is a biologically enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer. 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.