On September 26, 2016 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that the first patient was dosed in the Phase I/II trial of its lead candidate, CAN-008, for the treatment of newly-diagnosed glioblastoma multiforme (GBM), in Taiwan (Press release, CANbridge Life Sciences, SEP 26, 2016, View Source [SID:SID1234515418]). The patient was treated at Linkou Chang Gung Memorial Hospital, in Taipei, Taiwan. CAN-008, CANbridge’s lead candidate, is an immunotherapy that enhances the immune system response to cancer and inhibits tumor cell growth. The combined Phase I/II trial will consist of an open-label, dose-escalation Phase I portion, with a primary endpoint of safety. Phase II will consist of a multi-center, double-blind, randomized, placebo controlled trial, with the primary endpoint and secondary efficacy endpoints of progression free survival, overall survival and safety, respectively. Overall, the trial will enroll a total of 55 patients. CANbridge expects to report Phase I safety data after mid-2017.
"CANbridge is now a clinical stage company, delivering on our mission to develop Western drug candidates for Asian markets, " said James Xue, CANbridge CEO. "It is of particular value to us that CAN-008 shows promise in glioblastoma multiforme, a terrible cancer that has had no new front-line treatments approved, anywhere in the world, since 1999. We are proud to bring a potentially new treatment option to this underserved group of patients."
"I am honored to lead this well-designed, high-quality clinical trial, " said principal investigator (PI) Kuo-Chen Wei (MD), Professor of Neurosurgery,Vice Chairman of Cancer Center, and Director of Brain Tumor Division, Linkou Chung Gung Memorial Hospital. "We look forward to doing all we can to explore CAN-008’s potential to make a meaningful difference in the treatment of GBM patients"
About CAN-008
CAN-008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.