ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced today that the company has completed enrollment for its Phase II randomized, double-blinded, placebo-controlled, multi-center trial of its dendritic cell-based cancer vaccine ICT-107 for treatment of glioblastoma. A total of 278 patients at 25 participating sites have been enrolled in this trial, which was initiated in January 2011.
“We believe that ICT-107 represents the next generation of cancer immunotherapy by targeting both tumor cells and cancer stem cells with a dendritic cell-based vaccine,” said John. S. Yu, MD, ImmunoCellular’s Interim Chief Executive Officer. “We deeply appreciate the oncology community’s enthusiasm for the ICT-107 clinical program and their shared interest in exploring the therapeutic potential of this potentially breakthrough technology, as reflected in the pace of enrollment in the trial. I congratulate the ImmunoCellular clinical team for this successful milestone in efficiently and rapidly completing enrollment in this complex clinical trial.”
“This potential vaccine tested in patients with Stage IV glioblastoma is designed to leverage the patient’s own immune system after surgery and chemo-radiation treatments to hunt and destroy remaining brain tumor cancer cells,” says Dr. John Boockvar, director of the Brain Tumor Research Group, associate professor of neurological surgery at Weill Cornell Medical College and a neurosurgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center - one of the clinical trial testing sites for the experimental vaccine. “Previous Phase I study results show the vaccine may improve patient survival by enabling them to remain disease-free longer when the vaccine is combined with standard treatments. I look forward to seeing the Phase II results.”
ICT-107 is a dendritic cell based vaccine targeting multiple tumor-associated antigens and cancer stem cells in development as a potential treatment for glioblastoma. ICT-107 is exclusively licensed by Immunocellular from Cedars-Sinai Medical Center. The Phase II trial of ICT-107 is a randomized, double-blinded, placebo-controlled, multi-center study in patients with newly diagnosed glioblastoma. The primary endpoint of the Phase II trial is overall survival (OS), and secondary endpoints include progression-free survival (PFS), OS and PFS at various time intervals, immune response (T cells) and safety. ImmunoCellular expects that the trial’s data safety monitoring committee will conduct an interim safety analysis when 32 events (patients deaths) have occurred, which is anticipated in the first quarter of 2013. Depending on the progress of the trial, final safety and efficacy results from the Phase II trial could be available late in the second half of 2013.