Geron Corporation (Nasdaq: GERN) today announced two presentations on
the company’s ongoing Phase 1 clinical trial of its human embryonic stem
cell-based therapy, GRNOPC1, in patients with spinal cord injury. Safety
data were presented at the Pre-Conference Symposia of the joint 2011
American Congress of Rehabilitation Medicine and American Society of
Neuro-Radiology Annual Meeting in Atlanta, GA. A second presentation was
given at the Working 2 Walk 2011 conference in Rockville, MD. The
presentations were given by Joseph Gold, Ph.D., Geron’s Senior Director
of Neurobiology and Stem Cell Therapies and Linda Jones, P.T., M.S.,
Geron’s Senior Clinical Trials Manager for GRNOPC1.
“We are pleased to report that the lowest intended dose of GRNOPC1 has
been administered to four patients with complete thoracic spinal cord
injuries,” said Stephen M. Kelsey, M.D., Geron’s Head of Research &
Development and Chief Medical Officer. “To date, GRNOPC1 has been well
tolerated with no serious adverse events.”
Phase 1 Clinical Trial Data
Data were presented on four patients with neurologically complete
American Spinal Injury Association (ASIA) Impairment Scale grade A
thoracic spinal cord injuries, who received GRNOPC1 at a dose of two
million cells delivered by injection into the lesion site using a
syringe positioning device designed by Geron. GRNOPC1 was administered
between 7 and 14 days after injury. Low-dose tacrolimus was given for
temporary immune-suppression from the time of injection for 46 days, at
which point the dose was tapered and withdrawn completely at 60 days.
Endpoints of the trial are safety and evaluation of neurological
function, using standardized testing at specified timepoints to monitor
sensory and lower extremity motor function. The trial protocol also
includes multiple MRI scans. Initial follow-up of patients is one year.
One patient in the trial has completed the Day 365 follow-up visit. The
most recent patient to be enrolled in the clinical trial has completed
the Day 30 follow-up. After one year the patients enter a period of
long-term follow-up that includes annual in-person visits for the first
five years and subsequent yearly check-ups via telephone for an
additional nine years.
Safety data to date from the trial has shown:
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No surgical complications during or after the procedures.
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No adverse events related to the injection procedures or to GRNOPC1.
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A few mild adverse events related to tacrolimus.
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No evidence of cavitation in the spinal cord at the injury sites on
MRI.
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No unexpected neurological changes.
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No evidence of immune responses to GRNOPC1.
GRNOPC1 was delivered to four spinal cord injured patients at a dose of
two million cells without complications from either the cells or the
surgical procedure itself, and without any negative effects on the
spinal cord or neurological function of the patients to date. The only
side-effects observed were due to the immunosuppressive drug tacrolimus,
which is administered for the first two months after injection of
GRNOPC1. Furthermore, there is no evidence to date of immune rejection
of GRNOPC1, an allogeneic cell therapy, including after withdrawal of
immunosuppressive drug.
About GRNOPC1
GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have
demonstrated remyelinating, nerve growth stimulating and angiogenic
properties leading to restoration of function in rodent models of acute
spinal cord injury. Preclinical studies have shown that administration
of GRNOPC1 significantly improved locomotor activity and kinematic
scores of rodents with spinal cord injuries when injected seven days
after the injury. Histological examination of the injured spinal cords
treated with GRNOPC1 showed improved axon survival and extensive
remyelination surrounding the rodent axons. For more information about
GRNOPC1, visit .
For further information about the Phase 1 clinical trial, including
location of clinical sites, visit .
About Spinal Cord Injury
Spinal cord injury is caused by trauma to the spinal cord that results
in a loss of motor control, sensatory perception, bowel and bladder
control, and numerous other voluntary or involuntary body functions. A
traumatic blow to the spine can fracture or dislocate vertebrae that may
cause bone fragments or disc material to injure the nerve fibers and
damage the oligodendrocyte cells that insulate the nerve fibers in the
spinal cord. Most human spinal cord injuries are contusions (bruises)
rather than lacerations to the cord. Every year approximately 12,000
people in the U.S. sustain spinal cord injuries. There are currently no
approved therapies for the treatment of spinal cord injury.
About Geron
Geron is developing first-in-class biopharmaceuticals for the treatment
of cancer and chronic degenerative diseases. The company is advancing
anti-cancer therapies through multiple Phase 2 clinical trials in
different cancers by targeting the enzyme telomerase and with a compound
designed to penetrate the blood-brain barrier. The company is developing
cell therapies from differentiated human embryonic stem cells for a
range of indications, with the first product in a Phase 1 clinical trial
for spinal cord injury. For more information, visit .
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 technologies and GRNOPC1 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 protection 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, filed with the
Securities and Exchange Commission, including the quarterly report on
Form 10-Q for the quarter ended June 30, 2011.

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