InVivo releases complete 6-month results from cancelled trial

InVivo Therapeutics (NSDQ:NVIV) today released complete six-month results from the company’s Inspire study of its neuro-spinal scaffold, which it ended in January after halting enrollment last July.

Results were presented by Dr. Stuart Lee of Vidant Health at the 2018 AANS meeting yesterday, the Cambridge, Mass.-based company said. The presentation was the first to include complete six-month data from the cancelled Inspire study.

InVivo’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

A total of 19 patients in the trial were implanted with the neurospinal scaffold, with three patients dying within two weeks of implantation. Data indicated that 44% of patients who reached the six-month primary endpoint visit in the trial had an ASIA Impairment Scale conversion at six months, which was the primary endpoint of the trial.

The objective performance criterion for the study was a 25% AIS conversion rate based on published conversion rates for thoracic spinal cord injury as reported in literature, which the trial met, InVivo reports.

InVivo also presented results from the Contempo study, which was intended to provide natural history benchmarks for the neuro-spinal scaffold. The trial analyzed neurological recovery data from 170 patients across three registries of patients with spinal cord injuries similar to those in the Inspire trial. Results from the Contempo study “validated the company’s previously established OPC with AIS conversion rates,” the company said.

“I was honored to present these clinical findings at the AANS Annual Scientific Meeting, and I believe the complete six-month Inspire findings encourage future clinical investigation of the Neuro-Spinal Scaffold,” Dr. Lee said in a press release.

In March, InVivo said it won FDA investigational device exemption for a new pivotal trial of its neuro-spinal scaffold. The new trial is slated to enroll 20 patients with acute spinal cord injuries to explore the use of the company’s neuro-spinal scaffold in hopes that results will enhance existing evidence.

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