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Lineage's Spinal Cord Injury Cell Therapy Return To Clinical Testing

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  • Following feedback received from the FDA, Lineage Cell Therapeutics Inc (NYSE: LCTX) will submit an amendment to its Investigational New Drug application (IND) for OPC1, allogeneic oligodendrocyte progenitor cell transplant therapy for spinal cord injury (SCI).

  • The IND amendment will be submitted in Q4 of 2021.

  • In February, the Company entered into an exclusive option and license agreement with Neurgain to evaluate its Parenchymal Spinal Delivery (PSD) System in both preclinical and clinical settings.

  • Lineage will assess the safety and performance of the Neurgain PSD system to deliver OPC1 to the spinal cord in both the preclinical and clinical settings.

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

  • The Phase 1 clinical study data 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.

  • Price Action: LCTX shares are up 4.48% at $2.80 during the market session on the last check Tuesday.

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