11/29/12 -- International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO"
or "the Company"), a California-based biotechnology company focused
on the development of therapeutic products, today announced the achievement of
a critical milestone towards the clinical development of its stem cell therapy.
The Company's research and
development team has created the world's first human clinical-grade stem cell
lines with the ability to immune-match millions of individuals. ISCO's existing
research-grade parthenogenetic stem cell lines, one of which contains the most
common immune type in the Caucasian population and may be an immune-match to
approximately 70 million people, are used in pre-clinical development. These
new clinical-grade stem cell lines position ISCO to be able to conduct clinical
trials in the United States.
Dr. Semechkin, CEO and Co-Chairman
of the Board, comments, "We've been working diligently for three years to
perfect this technology, which was first developed by our scientific founder,
Dr. Elena Revazova in Moscow, and I'm excited to report that we have been able
to derive new stem cell lines in the United States under the US and California
regulatory frameworks. I'm optimistic that the new parthenogenetic stem cell
lines, by providing a potentially unlimited supply of cells and tissue for
transplantation, will be of great benefit to the medical community and patients
world-wide."
The new stem cell lines, created
using ISCO's proprietary technology, are the first of a new generation of
clinical-grade human parthenogenetic stem cell (hpSC) lines created in the
United States under US regulatory oversight and designed to meet FDA
regulations. The US Food and Drug Administration developed Good Tissue Practice
(GTP) and Good Manufacturing Practice (GMP) standards to ensure the safety of
products developed for clinical use. Conforming to GMP is extremely important
as it means that the cells can be used in clinical development programs.
The new lines have been confirmed by
independent third-party testing to be "homozygous" in the HLA coding
regions meaning that they have a simple genetic profile in the critical areas
of the DNA that code for immune rejection. This feature is one of the most
important differences of hpSC when compared with embryonic stem cells and a
distinct clinical advantage because of their ability to be immune-matched to
the patient. We expect the new lines to immune-match millions of individuals,
and will be added to ISCO's existing bank providing a platform from which to
develop cells and tissue for clinical use.
"The importance of this
breakthrough cannot be overstated," commented Dr. Craw, Executive Vice
President of ISCO. "Expanding our collection is not only important for our
therapeutic programs, but also further establishes our leadership position in
human stem cell technology. Achieving this critical milestone moves us along
the path to make the transition into a clinical stage company."
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?. 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.
To receive ongoing corporate
communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
To like our Facebook page or follow
us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation
and www.twitter.com/intlstemcell
Safe harbor statement
Statements
pertaining to anticipated developments, the potential uses of our technologies
(including our human clinical grade stem cell lines) 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.
