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In Vivo-Progress with the FDA

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  • In Vivo-Progress with the FDA

    InVivo Therapeutics Announces Objective Performance Criterion for The INSPIRE Study


    - Key Measure of Study Success -
    CAMBRIDGE, Mass. (Feb 29, 2016) ? InVivo Therapeutics Holdings Corp. (NVIV) today announced it has received approval of a significant protocol amendment from the U.S. Food and Drug Administration (FDA). The amended protocol establishes the Objective Performance Criterion (OPC) for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold? for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. An OPC is a measure of study success used in clinical studies designed to demonstrate safety and probable benefit in support of a Humanitarian Device Exemption (HDE) approval.
    The OPC for The INSPIRE Study is defined as 25% or more of the patients in the study demonstrating an improvement of at least one ASIA Impairment Scale (AIS) grade by six months post-implantation. Since The INSPIRE Study is designed to enroll 20 patients with complete (AIS A) spinal cord injuries (inclusive of the 5 patients enrolled in the company?s pilot trial) the OPC equates to having five patients convert to any other AIS grade by six months post-implantation. Natural history databases indicate that between 12-16% of patients with complete (AIS A) thoracic injury will spontaneously convert without treatment six months after injury.
    ?The approval of this amendment, which includes the OPC, is one of the most important regulatory milestones the company has reached to date. The OPC provides additional clarity regarding our path to commercialization,? said Mark Perrin, InVivo?s Chairman and Chief Executive Officer. ?We have made tremendous progress with the FDA over the past year in the design of The INSPIRE Study, and it is very rewarding to complete the design of a study that has the potential to change the standard of care for acute spinal cord injury patients.?
    HDE approval is not guaranteed if the OPC is met, and even if the OPC is not met, the FDA may approve a therapy if safety and probable benefit are supported by a comprehensive review of all clinical endpoints and preclinical results. The safety profile for the Neuro-Spinal Scaffold has been excellent to date.
    A new CEO?s Perspective discussing the history of The INSPIRE Study can be found on the InVivo Therapeutics website: