MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: 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.”
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 http://www.cirm.ca.gov/summary-application-ct1-05168.
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.
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 www.geron.com/GRNOPC1Trial/. For further information about the Phase 1 clinical trial, 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 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.
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 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 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.