Lineage Announces Submission of OPC1 Investigational New Drug Amendment for Treatment of Chronic and Subacute Spinal Cord Injury

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1, its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury (SCI). Receipt of FDA clearance of the INDa would enable the Company to initiate its DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, to evaluate the safety and utility of a novel spinal cord delivery device in both subacute and chronic SCI patients. The OPC1 cell transplant is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from traumatic cervical or thoracic SCIs.

“The submission of our IND amendment for OPC1 and its return to clinical testing represents a significant milestone for this program and a diligent effort by our team,” stated Brian M. Culley, Lineage CEO. “With so few opportunities for SCI patients to participate in clinical trials, it is a privilege to be able to re-engage with the community as part of our efforts to improve outcomes for individuals with a debilitating condition for which there currently are no FDA-approved treatments. Our team has made a significant effort to introduce improvements to the OPC1 program, including enhancements to the production process and quality of our product candidate and an improved delivery system compatible with our immediate use, thaw-and-inject formulation. We are encouraged by the meaningful quality of life and safety results observed with OPC1 in previous trials, and we look forward to building on that promising work. We are excited by the opportunity to initiate the DOSED study and the opening of the first clinical sites in early 2024, assuming no further comments are received from the FDA in the 30 days following our INDa submission.”