LOS ANGELES, Sept. 24, 2015 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced 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. 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.
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."
About CIRM
At CIRM, we never forget that we were created by the people of
California to accelerate stem cell
treatments to patients with unmet medical needs, and to act with a
sense of urgency commensurate with that mission.
To meet this challenge, our team of highly trained and
experienced professionals actively partners with both academia and
industry in a hands-on, entrepreneurial environment to fast track
the development of today's most promising stem cell
technologies.
With $3 billion in funding and
over 280 active stem cell programs in our portfolio, CIRM is the
world's largest institution dedicated to helping people by bringing
the future of medicine closer to reality.
For more information, please visit:
https://www.cirm.ca.gov/.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that
is developing immune-based therapies for the treatment of brain and
other cancers. ImmunoCellular has concluded a phase 2 trial of its
lead product candidate, ICT-107, a dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells. ImmunoCellular's pipeline also includes:
ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen
on stem cells in recurrent glioblastoma; ICT-140, a dendritic cell
immunotherapy targeting antigens on ovarian cancer stem cells; and
the Stem-to-T-cell research program which engineers the patient's
hematopoietic stem cells to generate antigen-specific
cancer-killing T-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 in the anticipated timeframe as well as the amount
and timing of reimbursement of expenditures from the CIRM grant
funding over the course of the phase 3 ICT-107 trial. 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
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SOURCE ImmunoCellular Therapeutics, Ltd.