US company Bold Therapeutics has launched an expanded clinical trial of its BOLD-100 therapy to be used in conjunction with chemotherapy as treatment of gastric, pancreatic, colorectal and bile duct cancer patients.
The trial will be a Phase Ib//IIa investigation of the treatment’s safety and efficacy alongside the use of FOLFOX Chemotherapy.
The FDA has approved the use of BOLD-100 as an investigational new drug meaning the company can now begin at the H Lee Moffitt Cancer Center & Research Institute in Tampa, Florida and USC in Los Angeles.
The treatment works by using a ruthenium small molecule treatment to modify the unfolded protein response, hindering GRP78. It stimulates the reactive oxygen process that halts the cell reproduction cycle. These processes lead to cell death in otherwise resistant cancers.
The treatment is designed to be used with chemotherapy or other cancer treatments in order to improve the outcomes of these treatments in solid or liquid tumors.
The company found the treatment effective as a monotherapy in its previous Phase I trial, involving 46 subjects who had advanced tumors. The trial proved to be safe and well tolerated with fewer hematologic and neurologic side effects.
The trial is currently recruiting in Canada across six different centers.
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