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International Stem Cell Corporation Announces Positive Animal Efficacy Results in Liver Disease Program
CARLSBAD, CA, Jan 07, 2013 (MARKETWIRE via COMTEX) --
International Stem Cell Corporation (OTCQB: ISCO)
(www.internationalstemcell.com) ("ISCO" or "the Company") a
California-based biotechnology company, today announced positive top
line efficacy results from its pre-clinical in vivo liver study. The
primary goal of the efficacy study was to demonstrate the therapeutic
equivalence of human parthenogenetic stem cell (hpSC)-derived
hepatocytes to adult liver cells as a prerequisite for using such
cells in the treatment of metabolic liver diseases including
Crigler-Najjar Syndrome.
Crigler-Najjar Syndrome (CNS) is a rare inherited disorder in which
bilirubin, a substance made by the liver, cannot be broken down by
the liver. The build-up of this toxic compound can lead to damage to
the brain, muscles, and nerves and eventually cause death. Current
treatment paradigms for CNS include phototherapy and blood
transfusions, but these do not treat the underlying cause of the
disease. Hepatocyte transplantation has emerged as a therapeutic
strategy, and has been successfully applied to treat patients with
CNS, however the extremely limited availability of human livers and
therefore of donated primary hepatocytes makes a stem cell based
approach attractive.
These ISCO study results demonstrate that the hpSC-derived
hepatocytes engraft in the liver of Gunn rats and behave in a similar
manner to primary human hepatocytes. The Gunn rat is a
well-established model of CNS and has been used extensively to study
bilirubin toxicity and hepatocytes transplantation. Additionally, the
study indicates that a single intrasplenic injection of hpSC-derived
hepatocytes results in a change in the plasma indirect bilirubin
level equivalent to that achieved by injecting primary hepatocytes.
Establishing the equivalence of hpSC-derived and donor-derived
hepatocytes in their ability to metabolize bilirubin supports the
thesis that hpSC-derived hepatocytes can be used therapeutically as a
substitute for donated primary liver cells.
"Achieving this milestone is very encouraging," said Dr. Andrey
Semechkin, CEO and Co-chairman of ISCO. "These results suggest that
hpSC-derived hepatocytes could be a well suited alternative to
donated primary hepatocytes as a source of cells in clinical
applications including the treatment of Crigler-Najjar Syndrome."
About International Stem Cell Corporation
International Stem Cell
Corporation is focused on the therapeutic applications of human
parthenogenetic stem cells (hpSCs) and the development and
commercialization of cell-based research and cosmetic products.
ISCO's core technology, parthenogenesis, results in the creation of
pluripotent human stem cells from unfertilized oocytes (eggs) hence
avoiding ethical issues associated with the use or destruction of
viable human embryos. ISCO scientists have created the first
parthenogenetic, homozygous stem cell line that can be a source of
therapeutic cells for hundreds of millions of individuals of
differing genders, ages and racial background with minimal immune
rejection after transplantation. hpSCs offer the potential to create
the first true stem cell bank, UniStemCell(TM). ISCO also produces
and markets specialized cells and growth media for therapeutic
research worldwide through its subsidiary Lifeline Cell Technology
(www.lifelinecelltech.com), and stem cell-based skin care products
through its subsidiary Lifeline Skin Care (www.lifelineskincare.com).
More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated
developments, the potential use of technologies to develop
therapeutic products and other opportunities for the company and its
subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements that
are not historical fact (including, but not limited to statements
that contain words such as "will," "believes," "plans,"
"anticipates," "expects" or "estimates") should also be considered to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products and the management of collaborations, regulatory approvals,
need and ability to obtain future capital, application of capital
resources among competing uses, and maintenance of intellectual
property rights. Actual results may differ materially from the
results anticipated in these forward-looking statements and as such
should be evaluated together with the many uncertainties that affect
the company's business, particularly those mentioned in the
cautionary statements found in the company's Securities and Exchange
Commission filings. The company disclaims any intent or obligation to
update forward-looking statements.
Contacts:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Dr. Ruslan Semechkin
Vice President, R&D
Phone: 760-940-6383
Email: ras@intlstemcell.com
Investor Relations:
MZ Group
Mark McPartland
Senior Vice President
Phone: 212-301-7130
Email: markmcp@mzgroup.us
Web: www.mzgroup.com
SOURCE: International Stem Cell Corporation
mailto:ir@intlstemcell.com
mailto:ras@intlstemcell.com
mailto:markmcp@mzgroup.us
http://www.mzgroup.com/
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