Cell Therapeutics Inc. (CTI) has announced it will file a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA) for the design of a phase III trial of 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/carboplatin in female NSCLC patients with performance status of 0, 1 or 2. The enrolment 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 pre- menopausal women in our Stellar 3 trial, where the Xyotax/carboplatin combination increased the median survival of this group by 34 per cent over the control arm," said James A. Bianco, president and CEO of CTI. "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."

Laurie Fenton Ambrose, president of the Lung Cancer Alliance, noted, "We are excited to learn that CTI is moving forward on a new clinical trial for women with lung cancer. This is exactly the kind of research we need to help us better understand not only lung cancer's genetic differences, but to provide patients with improved treatment options." The Lung Cancer Alliance is a national non-profit organization dedicated solely to patient support and advocacy for people living with lung cancer or those at risk for the disease.

Xyotax (paclitaxel poliglumex) 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. Blood vessels in tumour tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that Xyotax is preferentially distributed to tumours due to their leaky blood vessels and trapped in the tumour bed allowing significantly more of the dose of chemotherapy to localize in the tumour than with standard paclitaxel.