US-based ImmunoCellular Therapeutics has started treatment in the Phase III registrational trial of the company's immunotherapy product, ICT-107, in patients with newly diagnosed glioblastoma.
Scheduled to be conducted at approximately 120 sites in the US, Canada and the EU, the randomised, double-blind, placebo-controlled Phase III trial will be conducted in 414 HLA-A2-positive subjects.
The trial focuses on two endpoints, with the primary endpoint emphasising overall survival, which the FDA and EU regulators have declared appropriate for registrational clinical studies in glioblastoma.
The secondary endpoint emphasises on progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.
ImmunoCellular president and CEO Andrew Gengos said: "What we think differentiates our Phase III programme from any other in newly diagnosed glioblastoma is that it is based on data and insights from a placebo-controlled Phase II trial, and it uses the overall survival primary endpoint that is the only efficacy endpoint US and EU regulatory authorities will currently accept for registration.
"We think we have designed a set of protocol improvements into the Phase III trial that give ICT-107 the best probability of success.
"We want to express our sincere appreciation to the medical oncology community worldwide for their ongoing support of our Phase III trial and look forward to treating our first patients within Canada and Europe in the third quarter of 2016."
Glioblastomas defines the occurrence of cancerous tumours found in the cerebral hemispheres of the brain, causing headaches, nausea, vomiting, and drowsiness.
ICT-107 is a patient-specific, dendritic cell-based immunotherapy targeting multiple tumour-associated antigens on glioblastoma stem cells.
ImmunoCellular has secured the US Food and Drug Administration (FDA) agreement on a Special Protocol Assessment (SPA) related to the primary and secondary endpoints, as well as the statistical plan for the Phase III trial.