LOS ANGELES, June 15, 2015 /PRNewswire/ -- ImmunoCellular
Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced
the selection of PCT, LLC, a subsidiary of Caladrius Biosciences,
Inc. ("Caladrius") (NASDAQ:CLBS), as the US manufacturer for
ImmunoCellular's ICT-107 phase 3 registrational clinical program in
newly diagnosed glioblastoma, anticipated to begin in the second
half of 2015. Under the terms of the multi-year agreement, PCT will
provide current good manufacturing practice (cGMP) services for the
manufacture of clinical supplies of ICT-107, a dendritic cell-based
immunotherapy targeting six tumor-associated antigens. PCT, which
was previously engaged by ImmunoCellular to manufacture clinical
supplies of ICT-107 and the Company's other cancer immunotherapy
clinical programs, is also working with ImmunoCellular's European
contract manufacturer, PharmaCell B.V., to perform a technology
transfer process to harmonize the EU and US methods of production
of ICT-107 for the planned phase 3 registration trial. PCT's
facilities are registered with the FDA as human cells, tissues, and
cellular and tissue-based products (HCT/Ps) facilities, and
maintain GMP-compliant quality systems.
"Selecting our US manufacturer for the ICT-107 phase 3 trial is
an important step toward initiation of our registration program,"
said Andrew Gengos, ImmunoCellular
Chief Executive Officer. "We have been pleased with PCT's ability
to provide high quality, cost-effective and consistent
manufacturing, and have confidence in their ability to support our
phase 3 trial. Over the coming weeks, we look forward to announcing
additional key milestones toward initiating the phase 3 trial,
which have the potential to be major value-creating events for our
Company. We expect to be in position to begin patient enrollment in
the late third quarter or early fourth quarter of this year."
"We are extremely pleased that the leadership team at
ImmunoCellular has chosen to develop a long-term relationship
partnership with PCT in order to maintain the cell therapy
manufacturing reliability, quality, and cost efficiencies they have
come to expect," said Dr. Robert A.
Preti, President of PCT, and Chief Technology Officer of
Caladrius. "We feel our clients significantly reduce their clinical
development risk by manufacturing with PCT and leveraging our
Innovation and Quality infrastructure."
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.
About Caladrius Biosciences, Inc. (formerly NeoStem,
Inc.)
Caladrius Biosciences, Inc. is among the first of a new
breed of immunotherapy companies with proven expertise
and unique experience in cell process optimization, development,
and manufacturing. Caladrius is a cell therapy leader with
late-stage clinical programs based on a proprietary platform
technology for immuno-oncology, as well as additional platform
technologies for ischemic repair and immunomodulation, and
capabilities that support other cell therapy developers. This
integrated approach supports the industry in bringing significant
life-improving medical treatments to market. To learn more
about Caladrius, please visit www.caladrius.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 manufactured,
developed or commercialized. 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 required 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:
For ImmunoCellular Therapeutics, Ltd.
Jane Green
Investor Relations
415.348.0010
jane@jmgcomm.com
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SOURCE ImmunoCellular Therapeutics, Ltd.