Lineage Announces FDA Clearance of IND Amendment for OPC1 Cell Transplant for the Treatment of Spinal Cord Injury
Lineage Cell Therapeutics, Inc. (LCTX)
Company Research
Source: Business Wire
The DOSED Clinical Study Will Evaluate a Novel Delivery Device in Subacute and Chronic Spinal Cord Injury Patients CARLSBAD, Calif.--(BUSINESS WIRE)--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). Pursuant to the INDa, Lineage has initiated activities to open its first clinical site in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) study to evaluate the safety and utility of a novel spinal cord delivery device in subacute and chronic SCI patients. Initial site opening is expected to occur in the second quarter of 2024, following customary trial prepar
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Earnings
- 3/7/24 - Beat
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Analyst Actions
- 2/5/24 - Cantor Fitzgerald