Geron Corporation Presents Data From GRNOPC1 Trial

Geron Corporation announced two presentations on the Company’s ongoing Phase 1 clinical trial of the human embryonic stem cell-based therapy, GRNOPC1, in patients with spinal cord injury. Data were presented on two patients with neurologically complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries, who received GRNOPC1 at a dose of 2 million cells delivered by injection into the lesion site using a syringe positioning device specially designed by Geron. GRNOPC1 was administered between 7 and 14 days after injury. Low-dose tacrolimus was given for temporary immune-suppression from the time of injection for 46 days, at which point the dose was tapered and withdrawn completely at 60 days. Endpoints of the trial are safety and neurological function, using standardized testing at specified timepoints to monitor sensory and lower extremity motor function. The trial protocol also includes multiple MRI scans. One patient in the trial has completed the Day 180 follow-up visit and the other has completed Day 7 follow-up. There were no surgical complications during or after either procedure. No adverse events have occurred to date related to the injection procedures or to GRNOPC1. One patient experienced two mild adverse events related to tacrolimus, nausea and low magnesium, which are known to be associated with the immune-suppressive drug and were minor.