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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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