Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) has recently filed a Special Protocol Assessment (SPA) to the US FDA for the design of a phase III trial of combination therapy for women with advanced lung cancer.
The said trial, known as PGT307, will focus on women with normal estrogen levels, and will evaluate XYOTAX™ (paclitaxel poliglumex) in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1 or 2.
The trial is targeting to enrol 450 patients; the interim analysis is planned in the first half of 2008.
According to James A. Bianco, M.D., President and CEO of CTI:
"The basis for this trial is the survival benefit we saw among pre-menopausal women in our STELLAR 3 trial, where the XYOTAX/carboplatin combination increased the median survival of this group by 34 percent over the control arm.
Since doublet therapy is the standard first-line treatment for advanced NSCLC patients with normal performance status, this trial may reach a much larger segment of women with pre-menopausal estrogen levels who are diagnosed with the disease than our PGT306 single agent PS2 trial.
We believe based on preclinical and clinical results that XYOTAX will be beneficial to this patient population by taking a negative risk factor in lung cancer -- estrogen -- and turning it into one that enhances response to therapy."
Under investigation in non-small cell lung, ovarian, prostate and breast cancers, XYOTAX™ (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel (the active ingredient in Taxol®) to a biodegradable polyglutamate polymer, resulting in a new chemical entity.
Find more details from the press release.
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