LOS ANGELES, June 7, 2016 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today
announced that the first patient has been treated in the phase 3
registrational trial of ICT-107, the Company's lead cancer
immunotherapy product candidate, in newly diagnosed glioblastoma.
ICT-107 is a patient-specific, dendritic cell-based immunotherapy
targeting multiple tumor-associated antigens on glioblastoma stem
cells. The phase 3 trial is designed as a randomized, double-blind,
placebo-controlled study of 414 HLA-A2-positive subjects, which
will be conducted at approximately 120 sites in the US,
Canada and the EU. The primary
endpoint in the trial is overall survival, which the FDA and EU
regulators have identified as an appropriate endpoint for
registrational clinical studies in glioblastoma. Secondary
endpoints include progression-free survival and safety, as well as
overall survival in the two pre-specified MGMT subgroups.
"Treating our first US patient in the phase 3 registrational
trial for ICT-107 is a major milestone achievement for our Company,
for patients with brain cancer and their families and for our
shareholders," said Andrew Gengos,
ImmunoCellular President and Chief Executive Officer.
"ImmunoCellular is now one of the very few companies in the cancer
immunotherapy arena that we believe to be in the final stage of
clinical development. What we think differentiates our phase 3
program from any other in newly diagnosed glioblastoma is that it
is based on data and insights from a placebo-controlled phase 2
trial, and it uses the overall survival primary endpoint which is
the only efficacy endpoint US and EU regulatory authorities will
currently accept for registration. We think we have designed into
the phase 3 trial a set of protocol improvements that give ICT-107
the best probability of success. We want to express our sincere
appreciation to the medical oncology community worldwide for their
ongoing support of our phase 3 trial and look forward to treating
our first patients in Canada and
Europe in the third quarter of
2016."
The principal investigator on the trial is Prof. Dr.
Michael Weller, Chairman, Department
of Neurology, University Hospital Zurich,
Switzerland. Dr. Weller serves as the Chairman of the German
Glioma Network of the German Cancer Council, and serves as
President of the European Association for Neuro-Oncology (EANO). He
is also the Chairman of the Brain Tumor Group of the European
Organisation for Research and Treatment of Cancer (EORTC). A world
expert in glioblastoma treatment and research, Dr. Weller has
provided extensive support to ImmunoCellular relative to
interpretation of the phase 2 results and design of the phase 3
trial protocol, and served as the Company's clinical expert in our
end of phase 2 presentation to the European Medicines Agency
(EMA).
Dr. Weller commented: "Glioblastoma has remained to be one of
the most difficult to treat type of cancer for decades.
Conventional treatments such as radiotherapy and chemotherapy seem
to have reached their limits. In contrast, there is now emerging
evidence that harnessing the patient`s immune system to actively
combat this deadly tumor may change this. Moreover, modern medicine
increasingly tries to move away from "one-size-fits-all" approaches
to more individualized approaches. ICT-107 meets these requirements
in an ideal way, being an innovative design of immunotherapy taking
into consideration biological characteristics of both the patients
and their tumors. The phase 3 trial is well designed and will
benefit from important insights from the encouraging results of the
placebo controlled phase 2 trial."
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. ImmunoCellular has also been honored with a
$19.9 million award from the
governing Board of the California Institute for Regenerative
Medicine (CIRM), California's stem
cell agency, to implement the phase 3 registration trial. To
support timely patient enrollment at participating sites across ten
countries, ImmunoCellular has established agreements with the
European Organisation for Research and Treatment of Cancer (EORTC),
the Alliance for Clinical Trials in Oncology (the Alliance) in the
US, and the Canadian Brain Tumor Consortium.
For patients, families and physicians seeking additional
information about the ICT-107 phase 3 trial, please consult
www.clinicaltrials.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. The phase 3 registrational trial of lead product
candidate, ICT-107, a patient-specific, dendritic cell-based
immunotherapy targeting multiple tumor-associated antigens on
glioblastoma stem cells, has been initiated. ImmunoCellular's
pipeline also includes: ICT-121, a patient-specific, dendritic
cell-based immunotherapy targeting the CD133 antigen on cancer stem
cells in recurrent glioblastoma; ICT-140, a patient-specific,
dendritic cell-based 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, the timing for completion of the phase 3 studies,
whether the results will support registration filing with the FDA
or EMA and the whether the Company has sufficient resources to
complete the phase 3 trial and if successful, file an NDA.
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.