Geron has announced that its IND (Investigational New Drug application) for GRNOPC1 has been placed on clinical hold by FDA, pending the agency’s review of new nonclinical animal study data submitted by the company. GRNOPC1 is a cell therapy for neurologically complete, subacute spinal cord injury.
Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application of the product to other neurodegenerative diseases. The company has also been performing additional product characterization and conducting further animal studies. Data from this work has been submitted to the FDA.
Geron will work closely with the FDA to facilitate their review of the new data and to release the clinical hold. No patients have yet been treated in this study.