Lineage will evaluate Neurgain PDI system’s to deliver OPC1 to the spinal cord in both preclinical and clinical studies
Lineage Cell Therapeutics has signed an exclusive option and licence agreement with medical device firm Neurgain Technologies to assess novel parenchymal delivery injection (PDI) system for OPC1 to treat spinal cord injury.
OPC1 is Lineage’s allogeneic oligodendrocyte progenitor cell (OPC) transplant.
Neurgain is involved in the commercialisation of technology developed by neurosurgeons at the University of California San Diego (UC San Diego).
As per terms of the deal, the firms will conduct the clinical testing of Neurgain’s novel PDI system, which is designed to help administer cells to the spinal cord without halting the patient’s respiration.
During surgery, preventing the need to stop respiration is expected to reduce the complexity, risk, and variability of administering cells to the area of injury.
In 2021, Lineage is expected to assess the Neurgain PDI system’s potential to safely and efficiently deliver OPC1 to the spinal cord in both preclinical and clinical studies starting.
Neurgain PDI System has been designed for precise and on-target delivery of cells with accurate dosing. It includes a platform and manipulator with a disposable magnetic needle assembly.
Compact in size, the PDI system is attached directly to the patient during the procedure.
The OPC1’s SCiStar study is an open-label, 25-patient and single-arm trial evaluating three sequential escalating doses of OPC1 administered 21 to 42 days post-injury in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI).
The novel delivery system is expected to offer a significant improvement in usability and precision compared against the methods and tools used to deliver OPC1 cells in the phase 1/2a SCiStar study of OPC1 to treat acute cervical SCI.
Lineage plans to exercise its option to enter into a pre-negotiated licence and commercialisation agreement with Neurgain based on the positive results of the PDI system.
Following the agreement, Lineage may incorporate the PDI system into a later-stage clinical trial. It will also commercially offer OPC1 to treat patients with a cervical spinal cord injury, if approved.
Lineage CEO Brian Culley said: “The Neurgain PDI offers an easier, potentially safer, and commercially more attractive option to treat SCI patients and is preferable to the complicated gantry utilized in an earlier study.
“It also will allow us to incorporate our new ‘thaw-and-inject’ formulation of OPC1, thereby enabling faster patient enrollment via access to a larger number of clinical trial sites.”