www.fdanews.com/articles/174240-triphase-wins-fda-orphan-drug-designation-for-malignant-glioma-therapy
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Triphase Wins FDA Orphan Drug Designation for Malignant Glioma Therapy
November 25, 2015
The FDA has granted orphan drug designation to Triphase Accelerator’s marizomib for the treatment of malignant glioma, an aggressive form of brain cancer.
The proteasome inhibitor is being evaluated in combination with bevacizumab in patients with recurrent glioblastoma.
Triphase is developing marizomib in both IV and oral formulations. The IV formulation has been evaluated in more than 290 patients with solid and hematologic malignancies as a single agent and in combination with dexamethasone.
Triphase also is developing marizomib in combination with pomalidomide and dexamethasone in patients with relapsed and refractory myeloma.