InVivo Therapeutics Holdings Corp. has received conditional approval of a study protocol amendment from the U.S. FDA that will convert its ongoing pilot study into a pivotal probable benefit study.
Following an acute spinal cord injury, InVivo’s biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. That’s the principle at least. All the company needs is supportive clinical evidence.
InVivo’s tale is a long one, littered with adversity, yet seemingly finally on the right track. Not so long ago the company was looking decidedly fragile as the pivotal study into its core technology was delayed by procedural demands from the FDA. Now, following some positive results from that same study, that same FDA has issued conditional approval for a change that will turn a pivotal study into a pivotal probable benefit study.
With this transition, the study will be known formally 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.” The INSPIRE Study is designed to enroll 20 implanted patients, inclusive of the five patients already enrolled. The primary endpoint is defined as the proportion of patients achieving an improvement of at least one ASIA Impairment Scale (AIS) grade at 6 months post-implantation. A required minor change to the informed consent form has already been submitted to the FDA and full approval of the amendment is expected in the next 30 days.
“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,” said Mark Perrin, Chief Executive Officer and Chairman. “We anticipate completing enrollment in the pivotal probable benefit study and submitting an application for Humanitarian Device Exemption (HDE) approval in 2017.”
Source: Business Wire