FDA Grants Bold Therapeutics Orphan Drug Status for Gastric Cancer Treatment
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.