Program Expands Company's Commitment to Brain Cancer
LOS ANGELES--(BUSINESS WIRE)--
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
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.
Source: ImmunoCellular Therapeutics, Ltd.
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