SEATTLE, Aug. 18, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ: CTIC and MTA: CTIC) announced that enrollment has opened for a randomized phase II clinical study comparing the combination of OPAXIO (paclitaxel poliglumex, PPX) and radiation ("RT") to the combination of temozolomide ("TMZ") and RT for patients with newly diagnosed glioblastoma, a high-grade malignant brain tumor.
The objectives of the study are to determine if OPAXIO and RT improve progression free survival ("PFS") and overall survival ("OS") compared to TMZ and RT as well as to evaluate neuro-cognitive function and toxicities of these therapies. If positive, results from the study could be used to plan a phase III study of OPAXIO added to standard radiation therapy for approval in this disease.
Glioblastoma is the most common and deadliest type of primary brain tumor in adults. It is estimated that 17,000 primary brain tumors are diagnosed each year in the U.S., 60% of which are gliomas with glioblastoma being the most prevalent. The prognosis for the great majority of patients with glioblastoma is poor with less than 25% of patients surviving two years with current therapies.
In a recent study, treatment with OPAXIO added to standard therapy with TMZ and RT resulted in a median PFS of 13.5 months in the subset of patients with GBS (n=17). Median OS has not yet been reached with 50% of patients having at least 22 months of follow-up since completing therapy. The study was presented in June 2011 by Drs. Suriya Jeyapalan, Heinrich Elinzano and Mark Goldman, Assistant Professors of Neurology and Neurosurgery, Brown University Oncology Group at the 2011 American Society of Clinical Oncology Annual Meeting. Additional survival data are expected to be presented at the Society of Neuro-Oncology annual meeting later this year.
"The data from the earlier OPAXIO study with an overal
|SOURCE Cell Therapeutics, Inc.|
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