International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com,
today announced that its stem cell therapeutic programs focused on
protective, transparent corneas (CytoCor™) in the front of the eye and
the light-sensitive retinal tissue (CytoRet™) in the back of the eye
will be formalized into a new business unit, Cytovis™. Together these
programs will leverage external and internal development, regulatory and
commercial expertise in cellular ophthalmology to form a focused
portfolio of complementary product candidates designed to address high
unmet medical needs with apparent pharmacoeconomic and quality of life
benefits.
CytoCor is the brand name for ISCO's corneal tissue that can be derived
from the company's proprietary parthenogenetic stem cells or commonly
used embryonic stem cells. Research and development with partners
Absorption Systems in the US, Sankara Nethralaya in India and Automation
Partnership in the UK continues for the purpose of optimizing the tissue
for transplantation in the 10 million people worldwide suffering from
corneal vision impairment and as an alternative to the use of live
animals and animal eyes in the $500+M market for safety testing of
drugs, chemicals and consumer products. ISCO's goal in the coming months
is to establish funding and infrastructure in India for accelerated
development of CytoCor for the therapeutic application and to advance
and implement the chemical testing application with partners in the US
and Europe.
CytoRet is the brand name for ISCO's stem cell-derived retinal tissue.
ISCO is using its parthenogenetic stem cells to develop individual
retinal pigmented epithelial ('RPE') cells and layered retinal
structures internally and in collaboration with the laboratory of Dr.
Hans Keirstead, Professor of Anatomy and Neurobiology at the University
of California, Irvine. ISCO recently commenced a new research
collaboration with UC Irvine to launch the next phase of its retinal
studies with that institution, including preclinical trials. Potential
therapeutic applications include retinitis pigmentosa, an untreatable
inherited disease affecting about 100,000 Americans, and the dry form of
age-related macular degeneration, a major cause of blindness in the
elderly of the Western world. ISCO's goal is to establish functional
proof of concept for RPE cellular therapy in models of human disease in
the next twelve-eighteen months.
Jointly referred to as Cytovis ('cyto' for cellular, 'vis' for vision),
these two cellular ophthalmology programs share a number of features and
benefits. First, with the aging of the population worldwide and the
growing number of work-related eye injuries in India, China and other
major countries, the market opportunity is growing steadily. Second,
there are strong pharmacoeconomic and quality-of-life rationales for
full or partial vision restoration or delay of vision impairment
diseases. Third, delivery of cells and tissues to the confined anatomy
of the eye inherently provides for better safety and efficacy than, for
example, the systemic circulation or the central nervous system. This
will likely result in lower regulatory barriers and shorter and less
costly development paths compared to that of anatomically deeper and
more widespread diseases. Fourth, a number of eye diseases cannot be
treated with surgery or traditional small molecule or protein
therapeutics, yet cell and tissue therapy is proven to work but
currently limited by availability of safe and sufficient cells and
tissue from human donors. Finally, eye care development programs like
CytoCor and CytoRet share a number of regulatory, development and
commercial aspects that make it feasible for a relatively small team to
produce substantial clinical outcomes and achieve competitive presence
in the marketplace alone or in collaboration with dedicated partners.
Brian Lundstrom, ISCO's President, says: 'ISCO's proprietary
parthenogenetic stem cell technology continues to form the foundation
for the company's long term regenerative medicine therapy programs. In
the nearer term, CytoCor and CytoRet's unique benefits in the field of
cellular ophthalmology offer the potential for partnering and funding at
a relatively early stage. Combined with the current and future revenue
of Lifeline Cell Technology and the revenue potential of Lifeline Skin
Care, scheduled for launch in the 4th quarter, Cytovis adds
significantly to ISCO's diversity and value creation potential for its
investor base in a cost-efficient fashion.'
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)
International Stem Cell Corporation is a California-based biotechnology
company focused on therapeutic and research products. ISCO's core
technology, parthenogenesis, results in creation of pluripotent human
stem cells from unfertilized oocytes (eggs). These proprietary cells
avoid ethical issues associated with use or destruction of viable human
embryos and, unlike all other major stem cell types, can be immune
matched and be a source of therapeutic cells with minimal rejection
after transplantation into hundreds of millions of individuals across
racial groups. ISCO also produces and markets specialized cells and
growth media for therapeutic research worldwide through its subsidiary
Lifeline Cell Technology, develops a line of cosmeceutical products via
its subsidiary Lifeline Skin Care and advances novel human stem
cell-based therapies where cells have been proven to be efficacious but
traditional small molecule and protein therapeutics do not. More
information is available at ISCO's website, www.internationalstemcell.com.
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FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and
therapeutic applications, the potential benefits of collaborations,
affiliations, 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," "should," "believes," "plans," "anticipates," "expects,"
"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, uncertainty in the results of
clinical trials or 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 these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation Kenneth C. Aldrich, Chairman 760-940-6383 kaldrich@intlstemcell.com or Brian
Lundstrom, President 760-640-6383 bl@intlstemcell.com |