Paclitaxel Poliglumex Gets Orphan Drug Designation for Glioblastoma Multiforme

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Cell Therapeutics, Inc, recently announced that paclitaxel poliglumex (OPAXIO) has been granted orphan drug designation by the FDA for the treatment of glioblastoma multiforme. Orphan designation was granted based on preliminary activity seen from phase II results of paclitaxel poliglumex when added to standard therapy (temozolomide plus radiation).

In this study, progression-free and overall survival was encouraging among patients with glioblastoma multiforme, including patients whose tumors expressed unmethylated MGMT (O[6]-methylguanine-DNA methyltransferase). Current standard therapy is less effective in patients with tumors that have unmethylated MGMT, an important DNA repair enzyme. A randomized trial is now underway for patients with glioblastoma multiforme with unmethylated MGMT, comparing standard temozolomide and radiation to OPAXIO and radiation.

Randomized Trial

“The current randomized trial is based on the encouraging results previously demonstrated with OPAXIO and radiation in patients with newly diagnosed malignant brain cancer and specifically targets GBM patients with a genomic marker, unmethylated MGMT, who are less likely to benefit from the current standard of care TMZ and radiation,” stated Howard Safran, MD, Medical Director of the Brown University Oncology Group, Providence, Rhode Island.

The study is expected to enroll up to 120 patients. Patients in the OPAXIO arm will receive OPAXIO once every week plus radiotherapy for 6 weeks. Patients in the temozolomide arm will receive daily oral temozolomide plus radiotherapy for 6 weeks. After completion of initial therapy, both arms will receive maintenance temozolomide on days 1 to 5 and then every 28 days for up to 12 cycles for a total of 48 weeks. ■




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