LOS ANGELES, Aug. 13, 2015 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced
today that it has reached agreement with the US Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) for the
phase 3 registrational trial of its cancer immunotherapy ICT-107 to
treat patients with newly diagnosed glioblastoma. The phase 3 trial
is designed as a randomized, double-blind, placebo-controlled study
of about 400 HLA-A2 positive subjects, which will be conducted at
about 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 stated is the 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. Patient enrollment is anticipated to begin in the late
third quarter or early fourth quarter of 2015.
A Special Protocol Assessment is a written agreement between the
sponsor company and the FDA on the design, clinical endpoints, size
and statistical design of a clinical trial intended to form the
primary basis of an efficacy claim in the marketing application,
such as a biologic licensing application (BLA) or a new drug
application (NDA). Final marketing approval depends upon the safety
and efficacy results demonstrated in the phase 3 clinical
program.
Andrew Gengos, ImmunoCellular's
Chief Executive Officer Commented: "We are pleased to have achieved
this important milestone, and think that successful completion of
the SPA process adds meaningful validation to the ICT-107 phase 3
program and design, especially the use of the gold standard primary
endpoint of overall survival. With this SPA in place, we think that
ICT-107 is uniquely positioned in the field of immuno-oncology
approaches being tested in glioblastoma. We are making significant
progress toward establishing our clinical site network and
obtaining the necessary institutional review board approvals. We
are confident that we are on track to begin patient enrollment in
the late third quarter or early fourth quarter of this
year."
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, including whether the SPA endpoints can be
achieved, and even if achieved whether the FDA will deem that
sufficient to approve ICT-107 and the timing of the initiation of
patient enrollment for the phase 3 study in the late third quarter
or early fourth quarter of this year. 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.