Novel Tx Granted Orphan Drug Status for Aggressive Brain Cancer

Triphase Accelerator announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to marizomib for the treatment of malignant glioma, an aggressive form of brain cancer with a significant unmet need due to its poor prognosis.

Triphase is currently evaluating marizomib in a proof-of-concept clinical study in combination with bevacizumab (Avastin) in patients with Grade IV malignant glioma (glioblastoma). Marizomib is also being studied in combination with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma, an indication that received an Orphan Drug designation from the FDA.

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Marizomib is being developed in both intravenous (IV) and oral formulations for hematologic malignancies and solid tumors. The IV formulation has been evaluated in clinical studies for use either as a single agent or in combination with dexamethasone, a histone deacetylase inhibitor, or an immunomodulatory drug. The oral formulation is being evaluated in preclinical studies.

Marizomib is a novel, irreversible, highly potent and brain-penetrant proteasome inhibitor.

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