International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com,
announced today that its oocyte collection and activation protocol has
received the approval of an Institutional Review Board (IRB). IRB review
and approval is a Federal requirement for all studies enrolling human
subjects, and ensures appropriate subject safety and monitoring to
protect subjects from unnecessary medical risks. 'Obtaining IRB approval
for our oocyte collection and activation protocol is a major step
forward towards the goal of building a viable bank of human
parthenogenetic stem cells,' said Dr. Simon Craw, Vice President of ISCO.
ISCO's breakthrough discoveries have resulted in unique stem cells
carrying distinct advantages over other human pluripotent stem cells.
ISCO uses unfertilized eggs (oocytes) to create human 'parthenogenetic'
stem cells (hpSCs). Like human embryonic stem cells (hESCs), hpSCs are
pluripotent, i.e. they have the capacity to become almost any cell type
in the body, yet avoid ethical issues associated with use or destruction
of viable human embryos. Unlike hESCs, hpSCs can be created in a form
such that they can be immunologically matched to millions of
individuals. This makes possible, for the first time, the establishment
of a bank containing a manageable number of stem cell lines immune
matched to a large patient population.
ISCO also announced that Prof. M. Kalichman of the University of
California San Diego and Director of the San Diego Research Ethics
Consortium has been engaged to provide help in creating an effective
system for the ethical review of ISCO's donor recruitment processes
including facilitating Stem Cell Research Oversight (SCRO) committee
review and approval. SCRO committee review involves the analysis and
approval of the scientific rationale, including any ethical
considerations associated with stem cell research. The SCRO committee
membership is mandated to include an ethicist, an assisted reproductive
technology expert, appropriate scientific expertise, a patient advocate
and a non-scientific member of the public.
Prof. Kalichman said, 'I look forward to working with International Stem
Cell Corporation to help with both identifying and recommending
solutions to the challenges of conducting ethically responsible research
with human stem cells.'
These achievements mark major milestones along ISCO's strategic path of
leveraging its discoveries and intellectual property to create a bank of
immune matched pluripotent human stem cells and their therapeutic
derivatives that can be used for clinical research and ultimately as a
valuable medical resource to the growing field of regenerative medicine.
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 most 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 of
differing racial groups. ISCO also produces and markets specialized
cells and growth media for therapeutic research worldwide through its
subsidiary, Lifeline Cell Technology, and is developing a line of
cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is
advancing novel human stem cell-based therapies where cells have been
proven to be efficacious but traditional small molecule and protein
therapeutics have 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 Simon
Craw, PhD, Vice President 760-940-6383 sc@intlstemcell.com |