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Complete Study Results Comparing CTI's OPAXIO(TM) With Gemcitabine or Vinorelbine in Performance Status (PS 2) NSCLC Patients Published in Journal of Thoracic Oncology
Date:7/6/2008

with the control arm (30 percent versus 5 percent, (p <0.001)), and grade 3 neuropathy occurred in 4 percent of the OPAXIO patients, with no occurrences of grade 4 neuropathy. There was a lower incidence of alopecia in the OPAXIO arm (2 percent versus 5 percent respectively, p = 0.085), as well as fatigue (16 percent versus 25 percent, p= 0.055), asthenia (11 percent versus 16 percent, p = 0.169), and weight loss (7 percent versus 12 percent, p = 0.121).

Details of the Study

The phase III trial, reported by Mary E. R. O'Brien, M.D., F.R.C.P., et al, of the Royal Marsden Hospital and the Kent Cancer Centre in Surrey, UK, was a randomized, multi-center trial. The trial was conducted at 83 centers in ten countries, and randomized on a 1:1 ratio to evaluate the efficacy and safety of this regimen in patients with chemotherapy-nave NSCLC. Patients with advanced stage IIIb/IV NSCLC and PS 2 were treated with OPAXIO on day 1 of a 21-day cycle, while patients receiving gemcitabine were treated on days 1, 8, and 15 of each 28-day cycle. Vinorelbine was administered on days 1, 8, and 15 of each 21-day cycle. Patients received up to six cycles of treatment, and were not treated until significant toxicities were under control (less than or equal to grade 1). The primary objective was effect on survival, and secondary objectives were determining the efficacy and safety of the treatments.

About OPAXIO(TM)

OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was previously branded as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is rendered inactive, potentially sparing normal tissue's exposure to high levels of the active drug and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules l
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SOURCE Cell Therapeutics, Inc.
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