Xyotax Retains Fast Track Status For Certain Female Lung Cancer Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
Trials of Xyotax in women with lung cancer who have normal estrogen levels are landmark studies using estrogen as a biomarker, CTI says.
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CellTherapeutics' Xyotax (paclitaxel poliglumex) has received FDA fast-track designation for use in the treatment of women with first-line advanced non-small cell lung cancer who have poor performance (PS2) status, the company announced April 11. FDA initially granted fast-track status to Xyotax in 2003 for NSCLC in both male and female patients. Since then, CTI has concluded through the analysis of successive failed trials that the patient population most likely to show a survival advantage with Xyotax is women with normal estrogen levels. As a result, the company will enroll only "women with normal estrogen levels either as a result of pre-menopausal age or hormone replacement therapy" in an upcoming Phase III research program. In an interview with "The Pink Sheet" DAILY in January, CTI CEO James Bianco was enthusiastic about using estrogen as a biomarker. "It's the first time someone is going to be doing this study specifically with the biologic marker of estrogen as a way to enhance a drug's therapeutic effect," Bianco said. "If we're correct, then we have a whole new area of science to explore ... not just in women, but in men," he said (1 (Also see "Cell Therapeutics CEO James Bianco: An Interview With “The Pink Sheet” DAILY" - Pink Sheet, 26 Jan, 2007.)). The Seattle company is planning two Phase III trials to test the hypothesis and has requested a special protocol assessment from FDA on both. The first, PGT306, is a study of Xyotax as a single agent that aims to enroll 300 PS2 women with advanced stage NSCLC who have not received prior chemotherapy. The second, PGT307, for which CTI requested an SPA in March, will study Xyotax in combination with carboplatin versus paclitaxel/ carboplatin in 450 female NSCLC patients with performance status of 0, 1 or 2, the company said. CTI said it expects to begin enrollment in one or possibly both trials in the second quarter, with a target interim analysis in the first half of 2008. Performance status is a World Health Organization scale used to describe how well potential trial patients are. PS2, for example, indicates a person who is up and about more than half the day but is not well enough to work. A performance status of zero means the person is fully active. Xyotax is a biologically-enhanced chemotherapeutic that links paclitaxel (the active ingredient in Bristol-Myers Squibb's Taxol ) to a biodegradable polyglutamate polymer. Since late 2006, CTI has been partnered with Novartis for the development of Xyotax (2 (Also see "Novartis Signs Development Deal With Cell Therapeutics For Xyotax" - Pink Sheet, 18 Sep, 2006.)). CTI expects data from two studies of a second cancer therapy, pixantrone, in aggressive non-Hodgkin's lymphoma to be available during 2007, with a possible NDA filing in early 2008 (3 (Also see "CTI Plans To File Pixantrone For Non-Hodgkin’s Lymphoma In Early 2008" - Pink Sheet, 13 Mar, 2007.)). Novartis has an option to participate in the development and commercialization of pixantrone, an anthracycline-based inhibitor of topoisomerase-2 that CTI maintains has a more favorable cardiac toxicity profile than anthracyclines and may prove to have more potent tumor activity than currently available drugs of that class. - Shirley Haley ([email protected]) |