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CANbridge Pharmaceuticals CAN008 Phase 2 Trial for Treatment of Glioblastoma Multiforme (GBM) in China Reaches Full Enrollment
CANbridge Pharmaceuticals, a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced that the CAN008 (asunercept) Phase 2 trial for the treatment of glioblastoma multiforme (GBM) in China is fully enrolled, with a total of 117 patients.
The multi-center, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of CAN008 plus temozolomide (TMZ) during and after radiation therapy in newly diagnosed patients and is a potentially registrational trial. Five-year follow-up data from the CAN008 Phase 1 trial showed 67% overall survival in the high-dose group and a median 17.95 months of progression-free survival in newly diagnosed GBM patients. The data were presented at the ESMO Sarcoma and Rare Cancers Annual Meeting in March. Interim data from the CAN008 Phase 2 GBM China trial is expected in mid-2023.
”Treatment with CAN008 significantly improved progression-free survival in the Phase 2 clinical trial of recurrent glioblastoma conducted by Apogenix in Germany,” said Wenbin Li, Director of Comprehensive Treatment Ward of Neuro-Oncology, Beijing Tiantan Hospital, Capital Medical University, principal investigator of the study. “The recently published long-term follow up data from newly diagnosed GBM patients in the CAN008 Phase 1 clinical trial is also encouraging, with 4 of the 7 patients in the 400mg/week dose group still alive at 5 years. We are pleased to have completed enrollment in the Phase 2 trial of CAN008, which we believe is a promising treatment that could provide new hope to patients. Thank you to all of the researchers and staff who helped ensure that patients got their medications during the difficult COVID-19 prevention and control period and to the patients, who put their trust in us.”
“We are delighted to have reached full enrollment in our Phase 2 glioblastoma trial for our first-in-class candidate, CAN008, in China, “ said James Xue, Ph.D., founder, chairman and CEO of CANbridge Pharmaceuticals Inc. “In addition, we are greatly encouraged by the five-year overall survival data of 67% in the high-dose group from our Phase 1 trial and look forward to the furthering the clinical development of CAN008 for patients in China.”
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