Proposition 71

Lineage Announces FDA Clearance of IND Amendment for OPC1 Cell Transplant for the Treatment of Spinal Cord Injury

Retrieved on: 
Dienstag, Februar 13, 2024
Research, Neurology, FDA, Clinical Trials, Stem Cells, Biotechnology, Pharmaceutical, Health, Science, Oncology, SCI, Spinal cord, Regenerative medicine, Person, Proposition 71, CIRM, Delivery, Injury, Quality of life, Food, Surgeon, Spine, Safety, Inda, Therapy, Lineage, Patient, Journal, Ventilation, Trial of the century, Pharmaceutical industry

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1 , an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI).

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1 , an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI).
  • The clearance of our INDa and the initiation of OPC1 clinical testing under our sponsorship represents a significant milestone for this program, and reflects our commitment to developing modern cell therapy product candidates,” stated Brian M. Culley, Lineage CEO.
  • We believe these improvements can lead to a safer surgical procedure for surgeons and patients.
  • The data from the Phase 1/2a clinical study of OPC1 in subacute cervical SCI is available here and the data from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here .

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

Retrieved on: 
Montag, Dezember 18, 2023
Stem Cells, Biotechnology, FDA, Health, Pharmaceutical, Neurology, Medical Devices, Research, Surgery, Science, Clinical Trials, Regenerative medicine, Delivery, Safety, Food, Therapy, Journal of Neurosurgery, IND, Lineage Cell Therapeutics, Inda, Proposition 71, Spinal cord, Patient, Journal, Injury, Spine, Investigational New Drug, NYSE American, Person, Trial of the century, Quality of life, TASE, SCI, Pharmaceutical industry, Neurosurgery

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).

Key Points: 
  • 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 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.
  • 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.