China-based biopharmaceutical company CANbridge Life Sciences has secured approval for the investigational new drug (IND) application from the Taiwan Food and Drug Administration (TFDA) to conduct the Phase I/II clinical trial of CAN-008 for patients with newly-diagnosed glioblastoma multiforme (GBM).
Developed by Apogenix, CAN-008 is a fully human fusion protein comprised of the extracellular domain of CD95 bound to the Fc region of human IgG, which blocks the CD95 ligand, a member of the tumour necrosis factor (TNF) family.
An inhibition of the CD95 ligand enables CAN-008 to restore the immune system’s anti-tumour response and blocks further invasive tumour cell growth.
The open-label, dose-escalation Phase I trial intends to determine the efficacy, safety, tolerability and pharmacokinetics profile of CAN-008 when administered during and after radiation therapy to patients with GBM.
The multi-centre, double-blind, randomised, placebo-controlled Phase II trial is designed to evaluate the efficacy and safety of CAN-008.
Both Phase I and Phase II trials will enrol approximately 55 patients with the Phase I portion slated to begin next month.
CANbridge acting chief medical officer Mark Goldberg said: “This approval by the TFDA is a very important step in the development of CAN008 for patients with glioblastoma multiforme (GBM) brain tumours.
“Glioblastoma multiforme is a devastating type of brain tumour. Better therapies are desperately needed.
“We are pleased to be able to move the clinical programme forward and hope that CAN008 will prove an important advance, improving outcomes for patients with GBM.”
A European Phase II trial conducted by Apogenix has demonstrated benefits in patients with biomarkers for the CD95 ligand after being treated with CAN008.