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ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) today announced initiation of a phase I clinical trial of cancer vaccine ICT-121 as a potential treatment for patients with recurrent glioblastoma multiforme (GBM). The investigator-sponsored phase I trial is being conducted at Cedars-Sinai Medical Center in Los Angeles, CA, by Jeremy Rudnick, MD, and ImmunoCellular is supporting the trial by providing the ICT-121 vaccine. ICT-121 is a dendritic cell vaccine targeting CD133, an important cancer stem cell marker that is commonly overexpressed on a broad range of solid tumors.
The primary objective of the open label phase I trial is to assess the safety and tolerability of ICT-121. Secondary objectives include overall survival (OS) and progression-free survival (PFS) at six months after surgery as well as other response parameters. Approximately 20 patients who have had gross tumor resection and experience a first recurrence of GBM, and who are HLA-A2 positive, will be treated in the trial. Patients will be administered the vaccine once per week for four weeks during the induction phase, followed by a maintenance phase consisting of one treatment every two months until their supply of vaccine is depleted or they experience progressive disease.
“The initiation of the ICT-121 trial completes another important clinical milestone for ImmunoCellular and adds to the substantial pipeline progress we have made this year in advancing our ICT-107 phase II program in patients with newly diagnosed brain cancer,” said Andrew Gengos, ImmunoCellular Chief Executive Officer. “We are positioning our company as an emerging leader in cancer immunotherapy by building our dendritic cell-based vaccine pipeline, maintaining a strong financial underpinning, and planning for the future should we achieve success in our ongoing ICT-107 phase II trial. The second half of 2013 will be an exciting time as we expect to reach the prescribed event level in the ICT-107 trial that triggers analysis of the final results.”