Oct 20, 2011 07:30:02 (ET)
MENLO PARK, Calif., Oct 20, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN, Trade )
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was tapered and withdrawn completely at 60 days.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:
-- No surgical complications during or after the procedures.
-- No adverse events related to the injection procedures or to GRNOPC1.
-- A few mild adverse events related to tacrolimus.
-- No evidence of cavitation in the spinal cord at the injury sites on MRI.
-- No unexpected neurological changes.
-- 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 www.geron.com/GRNOPC1Trial/ . For further information about the Phase 1
clinical trial, including location of clinical sites, visit http://clinicaltrials.gov/ct2/show/NCT01217008 .
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 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 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.
SOURCE: Geron Corporation
MENLO PARK, Calif., Oct 20, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN, Trade )
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:
-- No surgical complications during or after the procedures.
-- No adverse events related to the injection procedures or to GRNOPC1.
-- A few mild adverse events related to tacrolimus.
-- No evidence of cavitation in the spinal cord at the injury sites on MRI.
-- No unexpected neurological changes.
-- 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 www.geron.com/GRNOPC1Trial/ . For further information about the Phase 1
clinical trial, including location of clinical sites, visit http://clinicaltrials.gov/ct2/show/NCT01217008 .
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 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 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.
SOURCE: Geron Corporation
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