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Geron Provides GRNOPC1 Data

November 7, 2007

Geron reports that GRNOPC1, a human embryonic stem cell-based therapeutic for spinal cord injury, exhibits durable and robust human remyelination in rats with spinal cord injuries for at least nine months following a single injection.

Data showed GRNOPC1 does not amplify neuropathic pain or the reaction to painful stimuli. This finding is in contrast to research showing many other cell types, when injected into the spinal cord, amplify neuropathic pain, Geron said.

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. GRNOPC1-treated animals exhibited no increase in allodynia or neuropathic pain compared with untreated spinal cord-injured animals at any time, the company added.

Geron’s development plan for the product calls for the filing of an investigational new drug application with the FDA and, pending the agency’s review, initiation of human clinical trials in 2008.