InVivo Therapeutics Reaches Key Regulatory Milestone

InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) announced that it’s received approval for a significant protocol amendment from the US Food and Drug Administration (FDA).
As quoted in the press release:

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.

Mark Perrin, chairman and CEO of InVivo, commented:

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. 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.

Click here to read the full InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) press release.