InVivo surges as spinal scaffold trial approaches endpoint

InVivo Therapeutics (NSDQ:NVIV) saw shares jump as much as 25% today after announcing positive 6-month results for its 5th patient in the Inspire study of its neuro-spinal scaffold, designed to treat patients with complete thoracic AIS A spinal cord injuries.

The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

“We are encouraged to see this patient’s significant neurological progress. This 3rd conversion brings us one step closer to achieving the Objective Performance Criterion for the Inspire study. Our goal is to approach full enrollment of the pivotal Inspire study by the end of the year, which will allow for an HDE submission in 2017,” CEO Mark Perrin said in a press release.

InVivo reported that the patient moved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury between their 3 and 6 month post-injury assessments.That brings the total up to 3 of 5 patients that have demonstrated an AIS grade improvement by 6 months, the company said.

That’s good news for InVivo, who saw shares leap as high as 25% in the early hours of trading today, now up 23.2% to trade at $9.27.

The company has shown significant momentum over the past 2 weeks, announcing the addition of 2 clinical sites, in Greenville, N.C. and Louisville, Ky., to its Inspire study, as well as reporting that the FDA  accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its neuro-spinal scaffold.

InVivo said its HDE modular shell for the Neuro-Spinal Scaffold is composed of 3 modules, including a preclinical study module, manufacturing module and clinical data module. The submission of the final module triggers a 75-day HDE review clock, the company said.

Last Monday, InVivo said 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.

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