Cell Therapeutics, Inc. (CTIC) today announced that its paclitaxel poliglumex drug OPAXIO has been granted orphan-drug designation by the U. S Food and Drug Administration for the treatment of malignant brain cancer (glioblastoma multiforme). CTIC stock closed up 11.2% on the 4fold of its 10day average volume.
Phase 2 study has been initiated at Brown University Medical Center. Howard Safran, M.D., Medical Director of the Brown University Oncology Group, stated:
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. We are pleased OPAXIO has been granted orphan-drug designation as patients with this disease have a serious unmet medical need for improved long-term survival particularly when MGMT is unmethylated.
Cell Therapeutics, Inc.
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Cell Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing novel agents that seek to improve the safety and efficacy of existing standard-of-care cancer treatments, and those that may have unique, new mechanisms to kill cancer cells.