ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular” or the “Company”) (NYSE MKT: IMUC), a clinical stage biotechnology company that is focused on developing new immune-based products to treat cancer, announced today that it will expand its current Phase IIb trial of ICT-107 from 102 to up to 123 patients with glioblastoma multiforme (GBM) and who are HLA-A1/A2 positive. There are currently 231 patients enrolled in the study and more than 105 patients have either been treated or are scheduled to be randomized and treated over the next few weeks. The Company expects to complete the expanded enrollment within the next 60 days.
“We believe that the increase in the number of patients may further validate the study, and accelerate the path to data analysis,” said Manish Singh, Ph.D., President and CEO of ImmunoCellular Therapeutics. “The additional patients could also provide for a more robust and meaningful trial.”
The Phase IIb trial of ICT-107 is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study has been enrolling patients at medical institutions in collaboration with leading experts and opinion leaders in neuro-oncology at those sites. An interim analysis is expected when 32 events have been observed. As the final analysis will be event-driven, increasing the number of patients treated, the Company believes it may shorten the trial by a few months compared to treating only 102 patients. This should also provide more information for robust sub-group analysis of the trial results, as differences in age, degree of resection, and other factors can impact overall survival.
In the Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care treatment of surgery, radiation and chemotherapy demonstrated two-year overall survival of 80 percent and a three-year overall survival of 55 percent. These figures compare favorably to the current 26 percent two-year overall survival and 16 percent three-year overall survival based on the historical standard of care treatment alone. Updated data from the 16 patients in the Phase I trial shows that patients treated with ICT-107 reported overall survival (OS) of 50% after four years and 38% of the trial patients are progression free (PFS) for 48-66 months. This compares very favorably to historic mean OS of 12.1% after four years and 5.6 % PFS after 48 months with standard of care alone. The clinical centers currently recruiting for this clinical trial and enrollment criteria are listed at: http://clinicaltrials.gov/ct2/show/study/NCT01280552?term=ICt-107&rank=1.About ImmunoCellular Therapeutics, Ltd. IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company is conducting a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more about IMUC, please visit www.imuc.com. Forward-Looking Statements for ImmunoCellular Therapeutics This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that obtaining the additional capital that will now be necessary to fund the increased costs for expanding the current trial and other costs associated with development of ICT-107 and completion of that trial may not be available to IMUC on attractive terms or at all; and the risk prior safety and efficacy results for ICT-107 will not be confirmed in current or any subsequent trials in statistically significant larger patient populations; and the risks associated with adhering to clinical timeframes. Additional risks and uncertainties are described in IMUC’s most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K. IMUC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.