FDA OKs expansion of InVivo Therapeutics spinal scaffold study

InVivo Therapeutics (NSDQ:NVIV) said today that the FDA cleared an expansion of its Inspire study of its neuro-spinal scaffold, now set to enroll up to 20 patients, and announced the 9th and 10th implantation in the trial, though the 10th patient died of an unrelated stroke.

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.

The federal watchdog cleared the company to expand the trial for up to 20 evaluable patients. The decision came based off the review of 6-month safety data from the trial, InVivo said.

“We are pleased that the FDA has approved expansion of the Inspire study that clears the way for enrolling all 20 evaluable patients. While the pause in enrollment for the last several weeks was unfortunate, this approval is an important step toward our goal of approaching full enrollment of the Inspire study by the end of the year. As is typical of the regulatory process, we have addressed a number of study design considerations regarding the Inspire study and its pilot precursor study over the last 2 years. We have begun a constructive discussion with the FDA regarding this study design consideration, and we will provide an update if substantial changes are made to the study protocol. We continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a Humanitarian Device Exemption application for marketing approval. Given the encouraging results that we have observed to date, we look forward to working with the FDA to complete the Inspire study as efficiently as possible,” Perrin said in a prepared statement.

InVivo said that the 9th and 10th patients have been implanted with the device, but that the 10th patient died of a stroke several days after the implantation procedure. The company said that the death was deemed to be unrelated to the Neuro-Spinal Scaffold or the procedure to implant it.

“We express our condolences to the family of the patient who passed away. Each loss of an individual with a spinal cord injury strengthens our resolve to develop and bring to market new treatments that will improve the lives of patients with these devastating injuries,” CEO Mark Perrin said in a press release.

Last month, InVivo touted a case study of the 1st implantation of its spinal scaffold.

The study, published in Neurosurgery, the journal of the Congress of Neurological Surgeons, involved a 25-year-old man with an American Spinal Injury Assn. Grade A spinal cord injury sustained in a motocross accident. Dr. Nicholas Theodore implanted an InVivo spinal scaffold directly into the traumatic cavity.

After 3 months, the patient had improved to a Grade C incomplete injury, according to the study, and at 6 months there were no procedural complications or safety issues related to the device. InVivo has said that the patient demonstrated an 8-point gain on the 50-point AIS lower extremity motor score and additional bilateral motor function improvements between the 6-month and 12-month follow-ups.

In December 2015, InVivo won conditional approval from the FDA to convert its the ongoing pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval. Earlier this year the company raised a $32 million funding round.

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