InVivo Therapeutics has been granted approval of a protocol amendment from the US Food and Drug Administration (FDA). This amendment will convert its ongoing pilot study into a pivotal probable benefit study. This approval was contingent only on a minor change to the informed consent form, according to an InVivo press release.
The INSPIRE study is to investigate the InVivo Neuro-Spinal Scaffold.
The study will now be formally known as “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.” It is designed to enrol up to 20 implanted patients, including those five already enrolled in the study.
The INSPIRE study is currently approved to enrol up to 12 patients, but, according to a press release, InVivo expects that the FDA will approve the full 20 patients following the review of the complete 6-month data package for the first five patients. The company plans to submit these data in the second quarter of 2016.
An objective performance criterion (OPC) for the study to support probable benefit using historical benchmarks is under discussion with the FDA. In large European and US databases, the published rates of spontaneous improvement of at least one AIS grade in complete (AIS A), thoracic SCI patients at six months are less than 16%. An additional study protocol amendment may be required to establish the OPC.
“Receiving full approval to convert our pilot study into a pivotal probable benefit study is a significant step forward for InVivo,” says Mark Perrin, chief executive officer and chairman. “Just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the intent to file an application for HDE approval.”