LOS ANGELES, Jan. 13, 2014 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
provided an update on the Company's anticipated 2014 corporate
strategies and milestones.
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"2013 was an eventful year for ImmunoCellular Therapeutics,"
said Andrew Gengos, ImmunoCellular's
Chief Executive Officer. "It was a year of progress, and some
challenges – quite typical for a development-stage biotechnology
company that is breaking new ground with a novel technology to
treat cancer. As we enter 2014, we are focused on advancing our
pipeline of cancer vaccines, and on creating and delivering value
to all our stakeholders. We are committed to making the best
data-driven decisions we can about how we move forward and invest
our resources. We are confident that our clinical programs have
meaningful therapeutic and commercial potential, and intend to
ensure that our strategies are driven by appropriate medical and
scientific rationales. We are also confident that we have more than
enough resources to achieve our near-term goals and that we will
continue our progress in building a leading cancer immunotherapy
company and transforming the treatment of cancer."
ICT-107 Phase II Program
ImmunoCellular is committed to objectively assessing ICT-107's
therapeutic value. The Company believes that ICT-107 has the
potential to offer a meaningful difference for patients, and
anticipates that the additional information to be gathered as
analysis of the data from the phase II trial continues will
reinforce that view.
The next steps for ICT-107 include the following:
- Continue to monitor overall survival (OS) for patients in the
phase II trial. The Company thinks that the progression-free
survival (PFS) result could portend improvement in the OS result
over the next two to three quarters, as it continues to collect and
incorporate more survival data.
- Analyze immunological data relating to the patients and the
vaccine, to inform the phase III design and potential patient
selection. The Company plans to focus on three important categories
of data:
- Antigen expression in patient tumor samples, to determine if
there is a correlation between the expression of certain antigens
in patients' tumors and OS and PFS. The Company expects these data
to be available in the second quarter of 2014.
- Dendritic cell characterization data, focusing on two
indicators of dendritic cell activation that are statistically
predictive of OS in the treated patients. This information is being
analyzed now and may inform manufacturing assay development as well
as phase III trial design.
- Analysis of patient samples for vaccine-induced T-cell
activation, to enable determination of a potential relationship
between vaccine responders and OS. These results are expected to
become available in the second quarter of 2014.
- ImmunoCellular will submit an abstract for the 50th
Anniversary Annual ASCO meeting taking place May 30-June 3, 2014. If the abstract is
accepted, the Company will report on more mature OS results and
findings from the immunological analysis.
- ImmunoCellular plans to meet with FDA for an end-of-phase II
discussion of the ICT-107 trial results and future trial design.
The Company anticipates this meeting can take place late in the
second quarter or in the third quarter of 2014.
- In the second quarter, ImmunoCellular expects to have a
decision from the European Medicines Agency (EMA) on granting
ICT-107 orphan designation in the EU (orphan designation has
already been granted in the US), and plans for its first in-person
discussion with the EMA regarding ICT-107 clinical data also in the
second quarter.
ICT-121 and ICT-140 Programs
While advancing ICT-107 is ImmunoCellular's major focus in 2014,
The Company also anticipates progress in its ICT-121 program in
patients with recurrent GBM, being conducted at Cedars-Sinai
Medical Center in Los Angeles, and
in its ICT-140 program in patients with ovarian cancer.
- ImmunoCellular anticipates completing enrollment of the
investigator-sponsored ICT-121 phase I trial by the end of the
2014. A recent publication in Stem Cells Translational
Medicine by the Cedars-Sinai and ImmunoCellular team supported
the use of our CD-133 specific epitope vaccine for the treatment of
GBM and other cancers.
- ImmunoCellular expects the ICT-140 phase II trial in ovarian
cancer patients to begin enrolling in the third quarter of 2014.
The timing to begin that trial is directly tied to the Company's
decision to implement fourth-generation process improvements in its
dendritic cell vaccine manufacturing platform. These platform
improvements are designed to enable the Company to manufacture all
of its DC vaccines at or near commercial quality going
forward.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles area-based clinical-stage company
that is developing immune-based therapies for the treatment of
brain and other cancers. ImmunoCellular has concluded a phase II
trial of its lead product candidate, ICT-107, a dendritic
cell-based vaccine targeting multiple tumor-associated antigens for
glioblastoma. ImmunoCellular's pipeline also includes ICT-121, a
dendritic cell vaccine targeting CD133, and ICT-140, a dendritic
cell vaccine targeting ovarian cancer antigens and cancer stem
cells. To learn more about ImmunoCellular, 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 ICT-107 can be further successfully developed or
commercialized, the outcome and timing of our immunological data,
the outcome of our end-of-phase II meeting with the FDA, EMA grant
of orphan designation for ICT-107, our ability to show that PFS and
OS outcomes are related with respect to ICT-107 in a manner that
justifies further development and our ability to continue to our
ICT-121 and ICT-104 programs successfully and in a timely manner.
Additional risks and uncertainties are described in IMUC's most
recently filed quarterly report on Form 10-Q and annual
report on Form 10-K. Except as permitted by law, IMUC undertakes no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
SOURCE ImmunoCellular Therapeutics, Ltd.