ImmunoCellular Therapeutics Announces First Patient Receives Vaccine in Phase I Trial of Cancer Vaccine ICT-121 in Recurrent ...
December 23 2013 - 4:00PM
Business Wire
Program Expands Company’s Commitment to
Brain Cancer
ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT:
IMUC) announced today that the first patient in the phase I
clinical trial of ICT-121, a cancer vaccine targeting recurrent
glioblastoma multiforme (GBM, or brain cancer), has received the
vaccine. ICT-121 is a dendritic cell vaccine targeting CD-133, an
important cancer stem cell marker that is commonly expressed on a
broad range of solid tumors. The investigator-sponsored phase I
trial is being conducted at Cedars-Sinai Medical Center in Los
Angeles, CA. ImmunoCellular is supporting the trial by providing
the ICT-121 vaccine.
“The start of this ICT-121 trial signifies an expansion of our
commitment to developing treatments for patients with GBM, and to
the continued advancement of our pipeline of dendritic cell-based
immunotherapeutic cancer vaccines,” said Andrew Gengos,
ImmunoCellular’s Chief Executive Officer. “In 2014 we expect to
have three active cancer vaccine clinical programs, led by ICT-107
in newly diagnosed GBM and including ICT-140 in ovarian cancer and
ICT-121.”
Continued Mr. Gengos: “We are making progress in analyzing the
data from the recently completed phase II trial of ICT-107 in newly
diagnosed GBM, with the goal of informing our ongoing clinical and
regulatory strategies for this program and seeking a meeting with
the FDA. We are actively consulting with nationally renowned
neuro-oncologists to help establish an objective view of the
initial results, and we continue to receive encouragement about the
phase II trial from these discussions. They share our view that as
the survival data mature in 2014, there is the potential to see
clarification of the survival benefit of the ICT-107 treated group.
We continue to think that the progression-free survival (PFS) data,
which showed a statistically significant advantage of ICT-107 over
placebo, represents a meaningful indicator for how the overall
survival (OS) data might mature.”
Concluded Mr. Gengos: “I want to emphasize some key points
relative to ImmunoCellular’s corporate goals and strategies. We
intend to build a leading cancer immunotherapy company. We think
that our dendritic cell-based cancer vaccine platform has the
potential to transform cancer treatment, and that our cancer
vaccines in development today could represent new therapeutic
options for patients. ICT-107 is the first immunotherapy in a
well-designed and placebo-controlled trial to demonstrate safety
and a treatment effect in newly diagnosed GBM, a disease for which
nothing has been approved in the US since temozolomide in 2005. We
urge patients and other stakeholders to look beyond the
unsubstantiated commentary on the recent trial results to what we
and clinical experts believe are important findings from this
clinical program to date. We believe that ICT-107 has notched an
important advance in the development of new immunotherapy
treatments for GBM, and we are committed to its development. We
intend to continue to make high quality, data-driven decisions
about advancing and expanding our pipeline, and believe we have
sufficient financial resources to meet our near-term goals. We look
forward to continuing to meet both the challenges and opportunities
inherent in the drug development process.”
About the ICT-121 Phase I Trial
The primary objective of the open label phase I trial is to
assess the safety and tolerability of ICT-121. Secondary objectives
include overall survival (OS) and progression-free survival (PFS)
at six months after surgery as well as other response parameters.
Approximately 20 patients who have had gross tumor resection and
experience a first recurrence of GBM, and who are HLA-A2 positive,
will receive the vaccine in the trial. Patients will be
administered the vaccine once per week for four weeks during the
induction phase, followed by a maintenance phase consisting of one
administration of vaccine every two months until their supply of
vaccine is depleted or they experience progressive disease.
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 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. 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, whether the PFS data will continue to favorable
results seen in our phase II study or that the survival outcome may
change favorably with more data from patients, the outcome of the
post-phase II meeting with the FDA and whether our platform
technology can be used to develop successful cancer drugs.
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.
In this press release, you can identify forward-looking statements
by terms such as “may,” “will,” “should,” “could,” “would,”
“expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,”
“predict,” “potential,” “future,” “intend,” “certain,” and similar
expressions intended to identify forward-looking statements. You
can identify forward-looking statements by terms such as “may,”
“will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,”
“believe,” “estimate,” “project,” “predict,” “potential,” “future,”
“intend,” “certain,” and similar expressions intended to identify
forward-looking statements.
ImmunoCellular Therapeutics, Ltd.Investor RelationsJane
Green415.348.0010 direct415.652.4819 mobilejane@jmgcomm.com
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