22 June 2021 - - US-based clinical-stage biotechnology company Lineage Cell Therapeutics, Inc. (NYSE American) (TASE: LCTX) has provided an update on the clinical advancement of OPC1, its investigational allogeneic oligodendrocyte progenitor cell transplant therapy for the treatment of spinal cord injury.

Following feedback received from an interaction held with the US Food and Drug Administration last week under the FDA's Regenerative Medicine Advanced Therapy program, Lineage intends to submit an amendment to its Investigational New Drug application for OPC1 to support a Phase 1 clinical study to evaluate the safety and performance of Neurgain Technologies Inc.'s Parenchymal Spinal Delivery System to deliver OPC1 cells to the spinal cord.

In February, the company entered into an exclusive option and license agreement with Neurgain to evaluate its novel PSD system in both preclinical and clinical settings. The IND amendment is expected to be submitted to the FDA in 4Q21.

The data from the Phase 1 clinical study is intended to validate the Neurgain PSD system for use in a late-stage clinical study, expected to begin in 2022 following the completion of the Phase 1 study.

The Neurgain PSD system has been designed to allow for the administration of cells to the spinal cord without stopping the patient's ventilator during the procedure.

Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury.

The Neurgain PSD system has been designed to provide delivery of cells with accurate anatomical positioning and dosing, is more compact than existing devices and is attached directly to the patient during the procedure.

This innovative delivery system is expected to provide a significant improvement in usability and provide more flexibility to the surgeon when compared to the methods and tools utilized to deliver OPC1 cells in the completed Phase 1/2a SCiStar study of OPC1 for the treatment of cervical SCI.

Neurgain Technologies, Inc. is a medical device company that is developing technologies developed by neurosurgeons at the University of California San Diego.

Lineage plans to evaluate the safety and performance of the Neurgain PSD system to deliver OPC1 to the spinal cord in both the preclinical and clinical setting.

If results of these studies are positive, Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain.

Pursuant to that agreement, Lineage may integrate the Neurgain PSD system into a late-stage clinical trial and, if approved, commercial use of OPC1 for the treatment of patients with spinal cord injury. There currently are no FDA approved treatments for spinal cord injury.

A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions.

There are approximately 18,000 new spinal cord injuries annually in the US The cost of a lifetime of care for a severe spinal cord injury can be as high as USD5 m.

OPC1 is an oligodendrocyte progenitor cell transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with subacute spinal cord injuries.

OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath.

While variability exists for the precise duration of each phase, subacute SCI generally refers to the phase that is three to six weeks post-injury and chronic SCI refers to the phase beginning after the subacute phase.

The OPC1 program has been partially funded by a USD 14.3m grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy designation for its use in subacute cervical SCI and Orphan Drug designation from the FDA.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage's programs are based on its proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities.

With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials.