Boston Biomedical announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for its investigational compound, napabucasin, for the treatment of gastric cancer, including gastroesophageal junction (GEJ) cancer.

Napabucasin is an orally administered cancer stemness inhibitor designed to target STAT3 signaling pathways, thereby inhibiting stemness, the ability of cancer stem cells (CSCs) to self-renew and differentiate into heterogeneous cancer cells. 

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Data from a Phase 1b/2 study for napabucasin in gastric/GEJ cancer were previously presented at the American Society of Clinical Oncology 2015 annual meeting. The study found that treatment with napabucasin can be combined with weekly paclitaxel in patients with advanced pre-treated gastric/GEJ cancer. In heavily pre-treated patients, lesion regression, objective responses and prolonged stable disease were observed.

Boston Biomedical is currently conducting the BRIGHTER study, a Phase 3 clinical trial for napabucasin in combination with paclitaxel in patients with advanced gastric and GEJ cancer.

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