Home » FDA Grants Bold Therapeutics Orphan Drug Status for Gastric Cancer Treatment
FDA Grants Bold Therapeutics Orphan Drug Status for Gastric Cancer Treatment
May 12, 2021
The FDA has granted Vancouver, Canada-based Bold Therapeutics Orphan Drug designation for its ruthenium-based small molecule therapeutic, BOLD-100, as a treatment for gastric cancer.
The investigational drug is designed to induce cell death in tumors, targeting both solid and liquid tumors in combination with anti-cancer therapies.
The company is currently enrolling patients at six sites in Canada in a phase 1b trial to evaluate the drug in combination with the FOLFOX chemotherapy regimen (5-fluorouracil, leucovorin, oxaliplatin), as a treatment for advanced gastrointestinal cancers. The study is expected to progress to phase 2 later this year, with new sites added in the U.S. and South Korea.
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