On September 24, 2015 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported that the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, has awarded the Company $19.9 million to support the ICT-107 phase 3 registration trial in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, SEP 24, 2015, View Source [SID:1234507542]). The $19.9 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. ICT-107 qualified for grant consideration on the basis of being specifically engineered as an immunotherapy that preferentially targets and kills cancer tumor stem cells with the goal of preventing tumor recurrence following standard-of-care treatment.
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ImmunoCellular is on track to initiate the phase 3 ICT-107 trial in the fourth quarter of 2015, which will include approximately 120 clinical sites in the US, Europe and Canada, and will recruit about 400 patients. ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. The $19.9 million CIRM grant funds will be received by the Company over the duration of the trial as specified milestones are achieved.
"We are deeply appreciative to CIRM for their generous support and validation of the therapeutic potential of our ICT-107 dendritic cell-based immunotherapy. We share CIRM’s commitment to advancing potential breakthrough stem cell-based therapies to patients with unmet medical needs," said Andrew Gengos, ImmunoCellular President and Chief Executive Officer. "We are excited to be close to initiating our phase 3 registration trial. With this important grant of non-dilutive capital and our current cash, we are in position to cover the full external cost of conducting the trial and ensure high quality trial execution. Our strategic focus going forward will be on advancing our Stem-to-T-cell immunotherapy platform and pursuing additional related technologies to grow our pipeline – strategies that are key to achieving our goal of building a leading cancer immunotherapy company."