LOS ANGELES, Feb. 25, 2014 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced
that the European Medicines Agency (EMA) has granted orphan drug
designation for ICT-107 for the treatment of patients with
glioblastoma. Granting of orphan drug status in the EU provides
sponsor companies with incentives, including a 10-year period of
market exclusivity, access to a centralized review process, trial
design assistance and scientific advice during product development,
fee reductions, and tax incentives. ImmunoCellular has previously
received orphan designation for ICT-107 in glioblastoma in the
US.
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"Obtaining orphan designation in the EU for ICT-107 is an
important achievement for our Company, as we believe that it adds
value to our lead asset and creates additional development,
commercialization and partnering opportunities in the European
market," said Andrew Gengos,
ImmunoCellular's Chief Executive Officer. "We anticipate additional
milestones in the ICT-107 program in the coming months. We have
submitted an abstract and hope to present at ASCO new and updated
data from the phase II program, including immunological data
analyses. We expect to hold an end-of-phase-II meeting with the FDA
to discuss potential phase III planning, and assuming favorable
outcomes from those discussions, we could be in position to start
planning that trial later in 2014. We are formulating our EU
regulatory strategy in preparation for our first meeting with the
EMA. We are completing our fourth-generation manufacturing
process development, and plan to select a phase III manufacturer in
the second half of this year. We continue to believe that ICT-107
has significant therapeutic and commercial potential, and look
forward to advancing our development and regulatory
strategies."
ICT-107 is an intradermally administered autologous vaccine
consisting of the patient's dendritic cells pulsed with six
synthetic tumor-associated antigens: AIM-2, MAGE-1, TRP-2, gp100,
HER-2, IL-13Rα2. ImmunoCellular has completed a randomized,
double-blind, placebo-controlled phase II trial of the safety and
efficacy of ICT-107 in newly diagnosed patients with glioblastoma
multiforme following resection and chemoradiation.
Orphan drug designation in the European Union (EU) is granted to
a medicine that meets certain criteria: it must be intended for the
diagnosis, prevention or treatment of rare diseases that are
life-threatening or chronically debilitating; the prevalence of the
disease in the EU must not be more than five in 10,000 people; and
the medicine must be of significant benefit to those affected by
the condition.
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 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 timing and outcome of our planned
end-of-phase-II meeting with the FDA and whether or not we may be
in a position start a phase III study in 2014. 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
SOURCE ImmunoCellular Therapeutics, Ltd.