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ImmunoCellular, Novella to conduct Phase III registration trial of ICT-107 to treat glioblastoma

ImmunoCellular Therapeutics has entered into an agreement with a clinical research organization (CRO), Novella Clinical, to conduct the Phase III registration trial of its lead product candidate, ICT-107, in patients with newly diagnosed glioblastoma.

Novella provides clinical trial services for small to mid-sized oncology companies.

ImmunoCellular chief executive officer Andrew Gengos said: "Establishing this agreement with Novella Clinical moves us one more critical step forward in the implementation of our Phase III ICT-107 registrational trial.

"Novella’s special expertise in oncology clinical trials, combined with their strong international network, experience working with oncology cooperative groups, and reputation for high quality, efficiency and cost-effectiveness, make them an excellent partner for our ICT-107 program.

"We are rapidly building the infrastructure for our Phase III program and remain on track to initiate the trial later this year."

The Phase III trial of ICT-107 will include about 120 clinical sites in the US, Europe and Canada, and will enroll around 400 patients with newly diagnosed glioblastoma.

The company intends to initiate the Phase III trial in the fourth quarter of this year.

ImmunoCellular has concluded a Phase II trial of ICT-107, a dendritic cell-based cancer immunotherapy targeting multiple tumor-associated antigens for glioblastoma.