July 7, 2008 - Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced the publication of results from its randomized phase III trial comparing OPAXIO(TM) (paclitaxel poliglumex, CT-2103) with gemcitabine or vinorelbine for the treatment of PS 2 (performance status 2) patients with previously untreated non-small cell lung cancer (NSCLC) in the Journal of Thoracic Oncology (Volume 3, Number 7, July 2008). Results showed that overall survival was similar between the two arms (hazard ratio of 0.95; OPAXIO to control). Patients treated with OPAXIO required less supportive care including fewer red blood cell transfusions, hematopoietic growth factors, and opioid analgesics than those patients receiving either gemcitabine or vinorelbine. There were relatively few non-hematopoietic grade 3 or 4 toxicities in either arm. Additionally, patients receiving OPAXIO required fewer clinic visits due to its administration schedule, once every three weeks, and short infusion time, compared to patients receiving either gemcitabine or vinorelbine. The objective of the study, known as STELLAR 4, was to determine if OPAXIO would improve overall survival when compared with the standard single-agent treatments of gemcitabine or vinorelbine in PS 2 patients with advanced NSCLC who had not previously received chemotherapy. The trial did not meet the primary endpoint. Secondary objectives of the study included measuring the efficacy and safety of the treatments. OPAXIO did demonstrate similar overall survival and a reduction in the supportive care required by patients... Cell Therapeutics' Press Release -
