Journal of Neuroimmunology Publishes Study Results Showing That
Geron's Human Embryonic Stem Cell-Based Therapeutic for Spinal Cord
Injury Evades Direct Attack by the Human Immune System
Tuesday, November 13, 2007; Posted: 07:30 AM
More Breaking News about GERN
Geron Says Stem Cell-based Therapeutic GRNOPC1 Evades Direct Attack
By Human Immune System In Vitro - Quick Facts
*Geron Reports Results Of GRNOPC1 Study
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MENLO PARK, Calif., Nov 13, 2007 (BUSINESS WIRE) -- GERN | charts |
news | PowerRating -- Geron Corporation (Nasdaq:GERN) today announced
the publication of study results showing that GRNOPC1, the company's
human embryonic stem cell (hESC)-based therapeutic for the treatment
of spinal cord injury, evades direct attack by the human immune
system in vitro.
Published in the November online issue of the Journal of
Neuroimmunology, the results of research conducted by Ross Okamura,
Ph.D. and other Geron scientists suggest that unlike whole organ
transplants, cellular therapeutics derived from hESCs may provoke
only minimal immune reactions and that rejection may be controlled or
prevented by short courses of low-dose immunosuppressive drugs. The
results also support the position that patient-specific hESC lines
are not needed to prevent immune rejection.
Specifically, the research findings demonstrate that GRNOPC1 cells
are minimally recognized by both the innate (natural killer) and
adaptive (cytotoxic T cell) arms of the human immune system. In
addition, the data show that the cells are resistant to lysis by
human serum containing anti-Neu5Gc antibodies, which some scientists
believed was problematic for any hESC line derived on mouse feeders.
Geron's oligodendroglial progenitors express HLA class I antigen but
not class II markers, even after stimulation by inflammatory
cytokines. Analysis of factors secreted by these cells in the
presence of inflammatory cytokines show the induction of several
ligands, including B7-H1, which have been previously shown to enhance
successful engraftment across allogeneic barriers.
"We published evidence in 2004 showing that undifferentiated hESCs
are immunoprivileged, which means they are minimally recognized by
allogeneic human immune cells in vitro," said Thomas B. Okarma,
Ph.D., M.D., Geron's president and CEO. "This publication shows that
the same immune-privileged properties are displayed by differentiated
progeny of hESCs. In this case, they are oligodendroglial progenitors
for acute spinal cord injury. More importantly, the study results
suggest a possible reduction in the requirement for immunosuppressive
drugs in patients treated with OPC1 cells. This should minimize the
potential for side effects often attributed to these agents."
In the studies, GRNOPC1 cells were tested for susceptibility to both
immune effector cells and sera from multiple allogeneic normal
healthy individuals. GRNOPC1 cells stimulated very low levels of T
cell proliferation. Allogeneic T cell proliferation is a standard
measure of immune recognition of foreign transplanted tissue. Even
when GRNOPC1 cells were exposed to proinflammatory cytokines, such as
gamma-interferon or TNF-alpha, allogeneic T cell proliferation was
not induced.
In addition, GRNOPC1 cells were not lysed by natural killer cells,
the "innate" arm of the immune system. Finally, GRNOPC1 cells were
largely resistant to killing by antibodies present in the sera of
normal healthy individuals. Sera from eight of 10 individuals failed
to induce the killing of GRNOPC1 cells. The sera from the remaining
two individuals induced only 10% GRNOPC1 cell lysis.
GRNOPC1 is an allogeneic population of cells containing
oligodendroglial progenitors that is intended for transplantation
into the lesion site of patients with spinal cord injury to induce
tissue repair. Geron's development plan for the product calls for the
filing of an Investigational New Drug (IND) Application with the U.S.
Food and Drug Administration and, pending the agency's review,
initiation of human clinical trials in 2008.
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 www.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 Media and Investors: David
Schull, 858-717-2310 david.schull@
619-814-3511 tracey.milani@
http://www.tradingm
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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