Full Press Release Details
Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy in
Patients with Spinal Cord Injury
Patient Treated at Shepherd Center in Atlanta
MENLO PARK, Calif.--(BUSINESS WIRE)--October 11, 2010--Geron Corporation
(Nasdaq: GERN) today announced the enrollment of the first patient in
the company's clinical trial of human embryonic stem cell (hESC)-derived
oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this
Phase I study is to assess the safety and tolerability of GRNOPC1 in
patients with "complete" American Spinal Injury Association (ASIA)
Impairment Scale grade A thoracic spinal cord injuries. Participants in
the study must be newly injured and receive GRNOPC1 within 14 days of
The patient was enrolled at Shepherd Center, a 132-bed spinal cord and
brain injury rehabilitation hospital and clinical research center in
Atlanta, GA. Shepherd Center is one of seven potential sites in the
United States that may enroll patients in the clinical trial.
"Initiating the GRNOPC1 clinical trial is a milestone for the field of
human embryonic stem cell-based therapies," said Thomas B. Okarma,
Ph.D., M.D., Geron's president and CEO. "When we started working with
hESCs in 1999, many predicted that it would be a number of decades
before a cell therapy would be approved for human clinical trials. This
accomplishment results from extensive research and development and a
succession of inventive steps to enable production of cGMP master cell
banks, scalable manufacture of differentiated cell product, and
preclinical studies in vitro and in animal models of spinal cord
injury, leading to concurrence by the FDA to initiate the clinical
"We are pleased to have our patients participating in this exciting
research," said Donald Peck Leslie, M.D., medical director, Shepherd
Center. "Our medical staff will evaluate the patients' progress as part
of this study. We look forward to participating in clinical trials that
may help people with spinal cord injury."
David Apple, M.D., Shepherd Center's medical director emeritus and
principal investigator of the trial at Shepherd Center, said, "This
clinical trial represents another step forward in Shepherd Center's
involvement in an attempt to find a cure for paralysis in people with
spinal cord injury. Shepherd Center is an ideal place to conduct this
study because of our clinical expertise and the volume of patients
referred here for rehabilitation care."
In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is
also open for patient enrollment. As additional trial sites come online
and are ready to enroll patients, they will be listed on the Patient
Information pages of Geron's website at www.geron.com/patients/clinicaltrials/hESC.aspx
and on the NIH clinical trials registry, ClinicalTrials.gov, at
clinicaltrials.gov/ct2/show/NCT01217008?term=GRNOPC1&rank=1.
Further information on the criteria for patient eligibility for the
study is also available on ClinicalTrials.gov.
About Spinal Cord Injury
Spinal Cord Injury (SCI) is caused by trauma to the spinal cord that
results in a loss of such functions as locomotion, sensation or
bowel/bladder control. 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 glial cells that insulate the
nerve fibers in the spinal cord. Most human SCIs are contusions
(bruises) to the cord, rather than a severance of the nerve fibers.
Every year approximately 12,000 people in the U.S. sustain spinal cord
injuries. The most common causes are automobile accidents, falls,
gunshot wounds and sports injuries.
GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have
demonstrated remyelinating and nerve growth stimulating properties
leading to restoration of function in animal models of acute spinal cord
injury. Preclinical studies showed that administration of GRNOPC1
significantly improved locomotor activity and kinematic scores of
animals 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 rat axons. For more information about GRNOPC1, visit www.geron.com/GRNOPC1Trial/.
About Shepherd Center
Shepherd Center is a private, not-for-profit rehabilitation hospital
specializing in medical treatment, research and rehabilitation for
people with spinal cord injury and disease, brain injury, multiple
sclerosis, chronic pain and other neuromuscular conditions. Each year
Shepherd Center admits more than 940 inpatients and more than 530 day
program patients. Its staff also treats about 6,000 people on an
outpatient basis annually. For more information, visit Shepherd Center
online at shepherd.org.
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. 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 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, including the quarterly report
on Form 10-Q for the quarter ended June 30, 2010.
Anna Krassowska, Ph.D., 650-473-7765
Sanders, 404-350-7707