Biotechnology outfit Lineage Cell Therapeutics has announced that it will return to clinical testing with its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for the treatment of spinal cord injury (SCI).
Following feedback from the US Food and Drug Administration (FDA), Lineage says it intends to submit an amendment to its Investigational New Drug application (IND) for OPC1 to support a phase one clinical study to evaluate the safety and performance of Neurgain Technologies’ Parenchymal Spinal Delivery (PSD) System to deliver OPC1 cells to the spinal cord.
In February, Linegae entered into an exclusive option and license agreement with Neurgain to evaluate its novel PSD system in both pre-clinical and clinical settings. The IND amendment is expected to be submitted to the FDA in the fourth quarter of 2021.
The data from the phase one clinical study is intended to validate the Neurgain PSD system for use in a late-stage clinical study, expected to begin in 2022.
Brian Culley, Lineage’s CEO, said: “It is a privilege to report that our novel OPC1 program will be returning to clinical testing earlier than anticipated. There currently are few opportunities for SCI patients to participate in clinical trials, so we are excited to re-engage with these patients and their advocacy community as part of our efforts to improve outcomes for individuals with this debilitating condition, for which there are no FDA-approved treatments.”