ImmunoCellular Therapeutics (OTC:IMUC) said Thursday it has expanded the number of sites for its phase two clinical trial of ICT-107, a potential vaccine treatment for brain cancer.
Originally, the trial, which is now underway, was planned to be held at up to 15 clinical centres, but this number has now been increased to 20 or more, the Los Angeles-based company said.
ImmunoCellular has qualified 21 sites so far, and has submitted the trial to 12 prospective sites’ Institutional Review Board (IRB) for approval. Of these 12 sites, six have now received their IRB approval.
The phase two study is a double-blind, placebo-controlled test to determine the safety and efficacy in patients with newly diagnosed glioblastoma multiforme, an aggressive type of brain tumour.
The vaccine uses cancer stem cells to target multiple tumour-associated antigens, which generate an antibody response from the body’s own immune system.
In other words, white blood cells are primed in the lab to attach to markers present in brain tumours, and these cells are then injected back into the body, where they travel to the brain and attack tumour cells.
In the phase one trial, 80% of 16 patients showed a two-year overall survival rate, while44% also showed a progression-free survival rate. Even more, six of the 16 clinical patients are now disease-free.
“We are excited to accelerate and expand site enrollment of our Phase II clinical trial for ICT-107,” said president and CEO, Dr. Manish Singh.
“With this trial we look forward to generating data in support of the safety and efficacy of ICT-107 in the treatment of GBM and to further support the promising outcomes reported in our Phase I study.” —Deborah Sterescu