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What is OPAXIO™?OPAXIO™ (oh-packs-ee-oh) (paclitaxel poliglumex, CT-2103; formerly branded as XYOTAX) is our novel chemotherapeutic agent that links paclitaxel to a biodegradable polymer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. Because the polymer is water-soluble, OPAXIO can be administered without solvents and infused over an average of ten to twenty minutes. OPAXIO remains stable in the bloodstream for several days after administration; this prolonged circulation allows the passive accumulation of OPAXIO in tumor tissue.Currently, we are studying OPAXIO in pivotal trials for non-small
cell lung and ovarian cancers.
OPAXIO in Non-Small Cell Lung CancerTwo randomized phase III trials, STELLAR 3 and STELLAR 4, compared OPAXIO alone or in combination with carboplatin to standard therapy in PS2 patients with advanced NSCLC. STELLAR 2, also phase III, compared OPAXIO to docetaxel in patients with relapsed disease. Another phase III trial, PIONEER (PGT305), compared OPAXIO to paclitaxel in first-line treatment of PS2 women with advanced NSCLC. These studies treated more than 1,900 patients.The STELLAR trials did not meet their endpoints of superior survival. Instead single-agent OPAXIO resulted in similar efficacy, and with the exception of neuropathy, improved tolerability in both first-line and second-line treatment of advanced NSCLC. Hypersensitivity reactions were rare on the OPAXIO arms of the studies despite the lack of required premedications. In December 2006, in agreement with the Data Safety Monitoring Board, we closed the PIONEER trial and took patients off both treatment arms. Our decision was due in part to the diminishing utility of the PIONEER trial given our plans to submit a new protocol to the U.S. Food and Drug Administration (FDA). Clinical Trials for Women with Lung CancerA phase III clinical trial, known as PGT307, is currently recruiting women with advanced NSCLC who have pre-menopausal estrogen levels (> 30pg/mL) – a group who’s survival is significantly shorter than post-menopausal women. We received Special Protocol Assessment (SPA) approval from the FDA on the design of the trial.This phase III trial is expected to enroll 450 patients. Each study arm of approximately 225 patients will be randomized to receive either OPAXIO plus carboplatin, or paclitaxel plus carboplatin once every three weeks. Patients will be treated for up to six cycles. The primary endpoint is superior overall survival with several secondary endpoints including progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms.
OPAXIO Regulatory StrategyIn March 2008, we submitted and the European Medicines Agency (EMEA) accepted for review a marketing authorization application (MAA) seeking European approval for OPAXIO on equivalent effectiveness and improved safety as a single-agent in first-line PS2 NSCLC patients.In the United States, we plan to seek approval for the drug’s use in maintenance of ovarian cancer following complete remission after first-line treatment.
Contact CTIFor media inquiries:Dan Eramian, T (206) 272-4343 (800) 215-CELL (US) F (206) 272-4010 Media@ctiseattle.com  back to top
Posted May 13, 2008 Copyright © 2004-2008 Cell Therapeutics, Inc., Seattle, WA, USA. All rights reserved. "Making cancer more treatable" is a registered mark of CTI. |
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