ImmunoCellular Therapeutics to Present Long-term Survival Data from Clinical Study of ICT-107 in Glioblastoma Multiforme at American Society of Clinical Oncology Meeting - New Clinical Data Supports Long-term Efficacy of ICT-107 as 38% of Patients are Progression-Free After Four Years
May 31, 2012
LOS ANGELES, CA – ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the "Company") (OTCBB: IMUC) News), announced today it will present new data from the previously completed Phase I clinical trial of ICT-107, the Company’s lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. The abstract, titled “Correlation of survival with tumor antigen expression in patients with newly diagnosed glioblastoma receiving a multi-epitope pulsed dendritic cell vaccine” (Abstract #2087), has been accepted for presentation on June 2, 2012 from 1:15 PM to 5:15 PM, during the Central Nervous System Tumors General Poster Session. The data will show that there is downregulation of both the tumor associated antigens that ICT-107 is targeting as well as CD-133, a cancer stem cell (CSC) marker, in some of the patients. These observations suggest that targeting antigens highly expressed by CSCs is a promising strategy for treating patients with GBM.
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.
While not all 16 of the patients in the Phase I trial have crossed the five-year time point, three of the patients are disease-free for five years. Cancer stem cell population measured by CD-133 in patients who went through a second surgery has gone down by a multiple of 3-5 times. Usually the CSC population goes up 3-5 times with the standard of care treatment alone, which appears to validate ICT-107’s mechanism of action. The positive trend between the expression of gp-100, MAGE-1, AIM-2 and Her-2 and PFS appears to indicate that those cells are more susceptible to respond to the vaccination. In addition, several of these antigens were downregulated over time, further validating the mechanism of action of ICT-107. This new data follows previously announced two-year results showing an OS rate of 80% and a PFS rate of 44%, which compare very favorably to historic median survival rates with standard of care alone.
In ImmunoCellular’s follow-on Phase II trial of ICT-107, there are 213 patients enrolled to date, of which 100 patients have been either randomized (or treated with the product) or are waiting to complete radiation therapy prior to treatment. The Company recently announced that its Phase II trial is now on-going at 25 sites, with patients enrolled in leading medical centers such as Mass General Cancer Center and the Dana Farber Cancer Institute. ImmunoCellular plans to continue enrollment for a short time to ensure enough patients will be available for the data analysis. The trial, as originally designed, was to enroll over 200 patients to treat at least 102 patients with HLA-A1/A2 immunological subtypes.
“The continued impressive survival data we have seen to date and the timely enrollment in our ongoing Phase II trial, further build our confidence that targeting CSCs may provide a breakthrough in the treatment of GBM,” said Manish Singh, Ph.D., President and CEO of ImmunoCellular. “As we complete enrollment of our Phase II trial, we look forward to obtaining patient data.”
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