GERN comments..
Recent Advances in Cellular Reprogramming
No Impact on Human Embryonic Stem Cell Therapeutic Product Development
MENLO PARK, Calif., Nov 21, 2007 (BUSINESS WIRE) -- Geron Corporation (GERN)
today commented on the impact of recent advances in cellular reprogramming on the
development of human embryonic stem cell (hESC)-based therapies.
Advances in Cellular Reprogramming
As reported yesterday, two laboratories have generated what appear to be
pluripotent stem cell lines from human skin cells by permanently introducing a
number of specific gene sequences into the genome via live viral vectors. The
resulting "induced" pluripotent stem cell lines (iPS) expressed genes
characteristic of "embryonic" human stem cell lines, proliferated in vitro at
small scale for several months and displayed the ability to form teratomas and to
undergo differentiation in vitro to several functional cell types. Although the
iPS cells appear similar to human embryonic stem cells, they differed from hESCs
in global gene expression patterns, with over 1000 genes differentially
expressed, and they have not been extensively characterized.
No Impact on hESC Therapeutic Product Development
"This is beautiful science," said Thomas Okarma, Ph.D., M.D., Geron's president
and CEO. "These findings contribute to a better understanding of the molecular
biology of cellular differentiation. The work will enable the generation of
pluripotent lines from individuals who suffer from poorly understood genetic
diseases. Such lines will be useful in understanding how certain abnormal genes
induce dysfunction in particular cell types that lead to disease."
"Yet the results are unlikely to impact the development of stem-cell based
therapeutics," continued Dr. Okarma. "The notion of using an individually derived
pluripotent stem cell line as the source for the manufacturing of a therapeutic
cell type used only for that individual is not only extremely labor intensive and
technically difficult, it is economically unfeasible. Moreover, the often stated
reason to make individual lines is to avoid immune rejection as in organ
transplantation. However, immune rejection may not pertain to cells manufactured
from hESCs, as we have shown recently with our OPC1 cells, our hESC-based
therapeutic for spinal cord injury. These therapeutic cells made from hESCs are
immune-privileged and are not recognized by the human immune system in vitro
(Journal of Neuroimmunology, December 2007, 192(1-2): 134-144)."
"What is most important to recognize is that an undifferentiated stem cell is not
a therapeutic cell," said Dr. Okarma. "Geron has the preeminent global leadership
position using our own patented technologies developed over many years to
scalably and reliably manufacture therapeutic (differentiated) cells from
pluripotent stem cell lines, regardless of their source. Indeed, one of the two
labs successfully used Geron's proprietary methods (Nature Biotechnology,
September 2007, 25(9): 1015-1024) in order to produce cardiomyocytes from their
iPS cell lines derived from human skin."
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer
and chronic degenerative diseases, including spinal cord injury, heart failure
and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine
that target the enzyme telomerase through multiple clinical trials. Geron is also
the world leader in the development of human embryonic stem cell-based
therapeutics, with its spinal cord injury treatment anticipated to be the first
product to enter clinical development. For more information, visit
geron.com.
This news release may contain forward-looking statements made pursuant to the
"safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that statements in this press release regarding potential
applications of Geron's human embryonic stem cell technology constitute
forward-looking statements that involve risks and uncertainties, including,
without limitation, risks inherent in the development and commercialization of
potential products, uncertainty of clinical trial results or regulatory approvals
or clearances, need for future capital, dependence upon collaborators and
maintenance of our intellectual property rights. Actual results may differ
materially from the results anticipated in these forward-looking statements.
Additional information on potential factors that could affect our results and
other risks and uncertainties are detailed from time to time in Geron's periodic
reports, including the quarterly report on Form 10-Q for the quarter ended
September 30, 2007.
SOURCE: Geron Corporation
Geron
David L. Greenwood, 650-473-7765
Chief Financial Officer
info@geron.com
or
Russo Partners LLC
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