ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC), 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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