Menlo Park, Calif.-based Geron Corporation (GERN) said on November 7 that data from a study in rats show that the company’s human embryonic stem cell (hESC)-based therapeutic survives and regenerates the myelin sheath of damaged spinal cords for at least nine months after one injection.
According to the company, the data also show that the therapeutic, GRNOPC1, does not intensify neuropathic pain or the reaction to painful stimuli.
The company said it hopes to get FDA approval for testing the therapeutic among humans next year.
The company said the finding is “in contrast to research that shows many other cell types, when injected into the spinal cord, amplify neuropathic pain, a common long-term complication of spinal cord injury in man.”
The study data were presented by Geron’s Arjun Natesan, Ph.D., at the Society for Neurosciences Annual Meeting in San Diego.
“These important results speak to both the long-term safety and duration of effectiveness of GRNOPC1,” said CEO Thomas B. Okarma. “A comparison of the GRNOPC1-treated rats at nine months after injection against untreated control rats shows dramatic evidence of durable remyelination of intact rat axons traversing the lesion. These results show that a single injection of GRNOPC1 cells produces significant and persistent remyelination of the damaged spinal cord.”
Allodynia, a painful response to a stimulus that normally does not elicit pain, was assessed on large numbers of GRNOPC1-treated and untreated spinal cord-injured rats at three, six, and nine months post-injury.
Both mechanical and cold stimuli were repeatedly applied at the injury site and on the paws by observers blinded to the animals’ treatment.
Measurements included vocalization, attendance to the stimulus site, and avoidance behaviors.
Treated animals exhibited no increase in allodynia or neuropathic pain compared to untreated spinal cord-injured animals at any time.
GRNOPC1 is an allogeneic (taken from different individuals of the same species) population of cells containing oligodendroglial progenitors that is intended for transplantation into the lesion site of patients with spinal cord injury to induce tissue repair.
Geron’s development plan for the product calls for the filing of an Investigational New Drug (IND) Application with the FDA and launching human clinical trials in 2008.
Geron is developing biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes.
Contact: http://www.geron.com
