| Geron announced its plan to advance clinical development of its human embryonic stem cell-based product, GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with complete thoracic spinal cord injury and to support future expansion of the trial to patients with cervical injuries. As announced previously, in one preclinical study, a higher frequency of animals developed cysts in the injury site than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1. These cysts are non-proliferative, confined to the injury site, smaller than the injury cavity, and were not associated with adverse effects on the animals. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, the company developed new candidate markers and assays. Data from studies using the new markers were submitted to the FDA. The IND for spinal cord injury was placed on clinical hold pending FDA review of the data. :theflyonthewall.com |
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