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Randomized Study Comparing Cell Therapeutics' OPAXIO (Paclitaxel Poliglumex) and Radiotherapy to Standard of Care Temozolomide and Radiotherapy Treatment Open for Enrollment
Date:8/18/2011

l survival not yet reached at a median follow-up of 22 months led us to quickly initiate this study. Only patients with glioblastomas without MGMT methylation will be eligible for this new study. Approximately half of all patients with glioblastomas have unmethylated MGMT and these patients have particularly poor prognosis with standard treatment with temozolomide and radiation so there is a serious unmet medical need -- particularly for MGMT-positive patients," commented Howard Safran, M.D., head of the Brown University Oncology Group. "There was strong interest in participating in this study based on those data and we hope to be able to enroll this trial on schedule."

The study is expected to enroll 60 patients. Patients in the OPAXIO arm will receive OPAXIO once every week plus RT for six weeks. Patients in the TMZ arm will receive daily oral TMZ plus RT for six weeks. After completion of initial therapy, both arms will receive TMZ on day 1-5 and then every 28 days up to 12 cycles for a total of 48 weeks.

About OPAXIO(TM)

OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, re
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SOURCE Cell Therapeutics, Inc.
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