Chinese biopharmaceutical company CANbridge Pharmaceuticals has announced plans to continue its Phase II study of CAN008 (asunercept) for the treatment of glioblastoma multiforme (GBM) in China.
The decision to continue the double-blinded study was based on an interim analysis carried out by the independent data monitoring committee.
A total of 119 subjects were enrolled and randomised at a 2:1 ratio to receive either 400mg of CAN008 intravenously along with standard-of-care chemoradiotherapy or placebo.
Subjects who had previously undergone surgical excision of a GBM tumour are included in the study.
Participants were initially given triple therapy of temozolomide, radiotherapy and CAN008 or placebo for a period of six weeks.
Following one month’s rest, they were then treated for 12 months with either a dual therapy of temozolomide and CAN008 or placebo.
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The final stage of the trial involved patients being given a monotherapy of CAN008 or placebo until either intolerability to treatment, disease progression, death or withdrawal.
Progression-free survival is the study’s primary endpoint while overall survival is its secondary endpoint.
CANbridge Pharmaceuticals founder, chairman and CEO James Xue said: “We are pleased that the independent data monitoring committee made the recommendation to continue the CAN008 Phase II glioblastoma multiforme trial in China, based on their analysis of the interim data.
“Glioblastoma is an intractable cancer with poor patient outcomes under standard-of-care.
“We look forward to continuing to develop CAN008 as a potentially new treatment for patients in China.”
CAN008 is a CD95-Fc fusion protein designed to improve immune recognition of GBM by inhibiting T-cell apoptosis and the invasive growth and migration of tumour cells.
CANbridge also develops therapeutics for treating rare cholestatic liver diseases, neuromuscular diseases, haemophilia A, metabolic disorders and Hunter syndrome.
The company has the rights to develop and market CAN008 for any indication in Greater China.