FDA is reviewing animal data that was submitted after the initial IND filing.
FDA has put a clinical hold on Geron’s human embryonic stem cell (hESC) therapy for spinal cord injury, because it is reviewing nonclinical animal data submitted after the IND filing. The IND covers the study of GRNOPC1 in neurologically complete, subacute spinal cord injury.
The new data submitted to the FDA was derived from studies to enable dose escalation and application of the product to other neurodegenerative diseases. The firm adds that it has also been performing additional product characterization and conducting further animal studies.
In January Geron was given the go-ahead to initiate a Phase I trial in patients with spinal cord injury. GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury, the firm explains.
