Geron Announces $25 Million in Funding from California Institute of Regenerative
Medicine
To Support Clinical Development of Cell Therapy for Spinal Cord Injury
MENLO PARK, Calif., May 04, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)
today announced that the company has been approved to receive a Targeted Clinical
Development Award totaling $25 million from the California Institute for
Regenerative Medicine (CIRM). The funding will support the clinical development
of GRNOPC1, Geron's cell therapy containing oligodendrocyte progenitor cells
derived from human embryonic stem cells (hESCs), currently in a Phase 1 trial in
patients with spinal cord injury.
"Bringing novel stem cell therapies to patients with an unmet medical need, such
as spinal cord injury, is a goal that we share with CIRM," said Jane S.
Lebkowski, Geron's Senior Vice President and Chief Scientific Officer, Cell
Therapies. "We are very pleased to announce the approval of this funding to
support Geron's clinical development of this first cell therapy derived from
human embryonic stem cells to reach clinical trials."
CIRM Funding
The Targeted Clinical Development Award was designed to facilitate clinical
development of novel cell therapies derived from pluripotent stem cells for the
treatment of disease or serious injury. Geron's application was approved for
funding by CIRM's governing board, the Independent Citizens Oversight Committee
(ICOC), on recommendation from the Scientific and Medical Research Working Group.
Geron is currently conducting a Phase 1 clinical trial of GRNOPC1 in patients
with neurologically complete injuries in the thoracic region of the spinal cord.
In this first cohort of patients, a dose of 2 million cells is being administered
to assess safety. Pending demonstration of safety, clinical testing will be
expanded to patients with injuries to the cervical region and to patients with
incomplete injuries, as well as to assess escalating doses of GRNOPC1. The Award
will support funding of clinical trial costs, supporting non-clinical studies,
analytical development and the manufacture of cells to be used in the clinical
trials. CIRM funding will provide a total of $25 million in matching support as
Geron moves through the Phase 1 trial. For further information regarding the
funded program, visit cirm.ca.gov.
The Award will be structured as a product-backed loan, such that Geron's
obligation for repayment will be contingent on commercial success of GRNOPC1 for
spinal cord injury.
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 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. A Phase 1 clinical trial of GRNOPC1 has
been initiated in patients with complete American Spinal Injury Association
(ASIA) Impairment Scale grade A thoracic spinal cord injuries. For more
information about GRNOPC1, visit geron.com. For further
information about the Phase 1 clinical trial, visit
clinicaltrials.gov.
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 or bowel and 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
oligodendrocyte cells that insulate the nerve fibers in the spinal cord. Most
human spinal cord injuries 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. 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 therapy products from differentiated
human embryonic stem cells for multiple indications, including central nervous
system (CNS) disorders, heart failure, diabetes and osteoarthritis, and has
initiated a Phase 1 clinical trial in spinal cord injury. For more information,
visit 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 March 31, 2011.
Undue reliance should not be placed on forward-looking statements, which speak
only as of the date they are made, and, except as required by law. Geron
disclaims any obligation to update these forward-looking statements to reflect
future events or circumstance.
SOURCE: Geron Corporation
Geron Corporation
Anna Krassowska, Ph.D., 650-473-7765
Investor and Media Relations
info@geron.com |
