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Canbridge Pharmaceuticals Studying CAN008 in Phase II Glioblastoma Multiforme Trial in China

NEW YORK – Canbridge Pharmaceuticals on Tuesday said the first patient has been dosed in a Phase II trial of its investigational agent CAN008 for glioblastoma multiforme in China.

The randomized, double-blind trial will compare Canbridge's CD95 Fc fusion protein CAN008 plus the standard of care, which comprises surgery followed by radiation therapy and temozolomide, against just the standard treatment plus placebo. Researchers will assess CAN008's efficacy and explore the ability of select biomarkers to predict treatment outcomes.

CAN008 is designed to bind to CD95L, which blocks the interaction between the CD95 receptor and its cognate ligand CD95L. This mechanism has shown in studies to inhibit tumor growth, limit programmed cell death among T cells, and enhance the immune system's ability to recognize cancer cells. A previous Phase I study of CAN008 plus chemotherapy in newly diagnosed glioblastoma multiforme demonstrated promising activity and acceptable safety and tolerability, the company said.

The drug has orphan designation in both the US and EU for glioblastoma multiforme. China's National Medical Products Administration has also deemed CAN008 a class I new drug, a designation given to new molecular entities that comes with five years of regulatory exclusivity in China.