InVivo Therapeutics (NSDQ:NVIV) said today it won conditional approval to convert its ongoing Neuro-Spinal scaffold pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval.
The conditional approval is based upon a change to the informed consent form the company already submitted to the FDA, and full approval is expected within the next 30 days, Cambridge, Mass.-based InVivo said.
“This conditional approval marks one of the most significant corporate milestones the company has achieved to date. Being able to convert our pilot study into a small pivotal probable benefit study provides us with a very efficient path to commercialization. We anticipate completing enrollment in the pivotal probable benefit study and submitting an application for Humanitarian Device Exemption approval in 2017,” CEO Mark Perrin said in a press release.
The newly titled Inspire study is conditionally approved to enroll 12 patients, but InVivo expects the FDA will approve the trial for 20 patients based on 6-month safety data from the 5 patients already enrolled. InVivo Therapeutics said it plans to submit that data in the 2nd quarter of 2016.
InVivo won approval to broaden its patient inclusion criteria to include patients with T2 injuries and patients aged 16-17, as well as expanding its U.S. site number to 40.
The study’s primary endpoint is the proportion of patients showing improvements of at least 1 ASIA Impairment Scale grade at 6 months after implantation with the scaffold. The company is still discussing objective performance criterions for the study with the FDA, and said it may require an additional study protocol amendment to establish it.
InVivo said it plans to initiate the study in Canada and the U.K. to include patients enrolled at ex-U.S. sites as part of the study.