InVivo Therapeutics (NSDQ:NVIV) said today the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic AIS A spinal cord injuries, establishing objective performance criterion for the trial.
The newly set OPC for the trial is defined as 25% more of the patients in the study demonstrating an improvement of at least one ASIA Impairment Scale grade at 6 months after implantation, the Cambridge, Mass.-based company said. An OPC is a measure used in clincal studies designed to demonstrate safety and benefit to support a Humanitarian Device Exemption.
“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,” CEO Mark Perrin said in a press release.
The Inspire study is slated to enroll 20 patients with complete AIS A spinal cord injuries, and will require 5 patients enrolled in the trial to convert to another AIS grade by 6-months to reach the OPC.
InVivo said that HDE approval is not guaranteed even if the OPC is met, and the device may be approved even if the OPC is not met, depending on if safety and a probable benefit are supported by a review of clincal endpoints and preclinical results.
Last week, InVivo saw shares rise as it announced the enrollment of the 6th patient in its Inspire pivotal clinical trial. The patient, who’s being treated at the Barnes-Jewish Hospital at Washington University Medical Center in St. Louis, Mo., was implanted with the InVivo device about 10 hours after a traumatic spinal injury, the company said.
Last month, InVivo Therapeutics said it won FDA approval to shift the Inspire pilot trial of its spinal scaffold to a pivotal probable benefit study. Earlier this month, the company added the University of California’s San Diego Medical Center as a site for the Inspire trial.
