07.11.2007 12:30:00
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Data Show Geron's Cell-Based Therapeutic for Spinal Cord Injury Survives and Exhibits Remyelination for at Least Nine Months Following Injection
Geron Corporation (Nasdaq:GERN) today announced that data show GRNOPC1,
the company’s human embryonic stem cell
(hESC)-based therapeutic for spinal cord injury, survives and exhibits
durable and robust human remyelination in spinal cord-injured rats for
at least nine months following a single injection.
Presented by Geron’s Arjun Natesan, Ph.D., at
the Society for Neurosciences Annual Meeting in San Diego, the data also
demonstrate that GRNOPC1 does not amplify neuropathic pain or the
reaction to painful stimuli. This finding is in contrast to research
that shows many other cell types, when injected into the spinal cord,
amplify neuropathic pain, a common long-term complication of spinal cord
injury in man.
"These important results speak to both the
long-term safety and duration of effectiveness of GRNOPC1,”
said Thomas B. Okarma, Ph.D., M.D., Geron’s
president and CEO. "A comparison of the
GRNOPC1-treated rats at nine months after injection against untreated
control rats shows dramatic evidence of durable remyelination of intact
rat axons traversing the lesion. These results show that a single
injection of GRNOPC1 cells produces significant and persistent
remyelination of the damaged spinal cord.”
Allodynia, a painful response to a stimulus that normally does not
elicit pain, was assessed on large numbers of GRNOPC1-treated and
untreated spinal cord-injured rats at three, six, and nine months
post-injury. Both mechanical and cold stimuli were repeatedly applied at
the injury site and on the paws by observers blinded to the animals’
treatment. Measurements included vocalization, attendance to the
stimulus site, and avoidance behaviors. GRNOPC1-treated animals
exhibited no increase in allodynia or neuropathic pain compared to
untreated spinal cord-injured animals at any time.
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.
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