LOS ANGELES, Sept. 17, 2014 /PRNewswire/
-- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE
MKT: IMUC) provides a corporate update on its plans to advance
ICT-107 to a registrational phase III program in patients with
newly diagnosed glioblastoma (GBM), and on its portfolio of
dendritic cell-based vaccines: ICT-121 for patients with recurrent
GBM; and ICT-140 for patients with ovarian cancer.
"We have now received supportive feedback from both the US FDA,
and European national regulatory authorities on the phase II
results of ICT-107 in GBM. Both governance bodies provided
encouraging suggestions for advancing ICT-107 into phase III
testing, and we are now accelerating preparations for trial
initiation in 2015," said Andrew
Gengos, ImmunoCellular Chief Executive Officer. "The new
input from the regulatory agencies supplements the feedback we have
already received from the medical and scientific community, and
increases our confidence in the potential therapeutic value of
ICT-107 in this deadly disease."
"As ICT-107 moves into phase III, we continue to monitor
surviving patients on the Phase II trial. We look forward to
presenting the next set of updated efficacy data at the upcoming
Society for Neuro-Oncology (SNO) meeting in Miami, FL. We are pleased to announce that our
SNO abstract has been selected for an oral presentation on
Friday, November 14, 2014," added Mr.
Gengos.
ICT-107: Phase III Registration Program Anticipated to Begin
Mid-2015
During the second and third quarters of 2014, ImmunoCellular
conducted discussions with regulatory authorities in the US and on
the national level in Europe
concerning the rationale, design and protocol of a phase III
program for ICT-107 in newly diagnosed GBM.
IMUC held discussions with FDA representatives on the potential
for future development of ICT-107 in glioblastoma in an
End-of-Phase II meeting. FDA was in agreement with the
proposed design of an IMUC phase III program which focuses on
HLA-A2 patients. HLA-A2 represents about 50% of GBM patients
in the US and Europe. Because GBM
patients partition into two distinct populations based on their
MGMT gene status and corresponding response to chemotherapy, the
Company proposed separate phase III trials for each of these two
populations. The FDA concurred with this approach and advised that
the alternative approach of a single trial with patients stratified
based on MGMT status also would be acceptable. The FDA indicated
that positive results in either of these phase III trials
demonstrating safety and efficacy, combined with data from the
phase II trial, would satisfy the requirements for a Biologics
License Application (BLA) submission. The FDA reiterated that
overall survival is the appropriate endpoint for these
registrational trials in glioblastoma. IMUC appreciated that the
FDA noted the positive benefit of ICT-107 in HLA-A2 patients and
commended the Company on the organized and efficient approach to
the phase III program. The Company anticipates additional
interactions with the FDA to finalize the phase III design and
protocol, with the goal of initiating the program in mid-2015.
ImmunoCellular met with European regulatory groups from
Germany, the United Kingdom and the Netherlands at a national level and
received encouraging feedback on the ICT-107 program and data
generated to date. Each group advised that the Company seek
scientific guidance from the EMA on the program, which we
subsequently requested in a submission containing similar
information to our End-of-Phase II submission to FDA. In the fourth
quarter, the Company anticipates receiving formal scientific advice
on next clinical and regulatory steps from the Committee on Human
Medicines, through the EMA, which will inform a decision on whether
to include EU sites in a phase III design. ICT-107 was recently
designated as an Advanced Therapy Medicinal Product by the EU
Committee for Advanced Therapies, which should provide access in
Phase III to valuable services and incentives offered by the EMA,
should the Company conduct the phase III program in the EU.
Oral Presentation of Updated ICT-107 Phase II Data at SNO
At the Society for Neuro-Oncology (SNO) meeting being held in
Miami, FL November 13-16, the principal investigator on the
ICT-107 phase II study, Patrick Y.
Wen, MD, Director of the Center for Neuro-Oncology at The
Dana Farber Cancer Institute and Professor of Neurology at
Harvard Medical School, will present
updated efficacy data from the trial. The platform presentation is
scheduled for Friday, November 14th,
at 3:45 pm ET.
Dr. Wen's presentation is titled "A randomized, double‑blind,
placebo-controlled phase 2 trial of dendritic cell (DC) vaccination
with ICT-107 following standard treatment in newly diagnosed
patients with GBM."
ICT-121 and ICT-140 Programs on Track; Business Development
Discussions Progressing
"We are also pleased with our progress in advancing the ICT-121
and ICT-140 programs, and look forward to the prospect of having
three active clinical programs underway," said Mr. Gengos. "The
required operational systems and manufacturing processes are now in
place to support our growing clinical portfolio, including the
large ICT-107 registration program, and we are continuing to manage
in a highly capital-efficient manner. On the business development
front, we continue to engage in discussions concerning partnering
for ICT-107. We have been active in exploring new immuno-oncology
technologies that could expand and complement our dendritic
cell-based platform, as well as combining our vaccines with other
targeted cancer immunotherapeutics. We look forward to keeping our
stakeholders apprised of our progress in the coming weeks and
months."
ImmunoCellular continues to advance its other two dendritic cell
vaccine programs: the ICT-121 program using cancer stem
cell-antigen-primed dendritic cells in patients with recurrent GBM,
and the ICT-140 program which uses a dendritic cell vaccine primed
by seven ovarian cancer-associated antigens in patients who are at
high risk for ovarian cancer recurrence. Additional clinical
sites are being added to the ICT-121 phase I trial, and enrollment
should increase shortly. The Company plans to complete enrollment
of 20 patients by the second quarter of 2015. Plans are progressing
well to initiate the exploratory phase II ICT-140 trial, which is
designed to enroll 56 patients and utilize historical controls as
the comparator in the trial.
ImmunoCellular plans to report third quarter 2014 financial
results and provide a corporate update in November, 2014. The
Company will host a conference call and webcast in conjunction with
that report.
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 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 interpretation of the meeting with the FDA and
EMA, whether or not we may be in a position to start a phase III
study in mid-2015, the continued progress and potential for success
of ICT-121 and ICT-140 and the timing and continued enrollment of
ICT-121. 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.