FDA Approves InVivo Therapeutics’ Expedited Enrollment for Ongoing Pilot Trial

The U.S. Food and Drug Administration (FDA) has approved InVivo Therapeutics Holdings Corp.for an expedited enrollment plan for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.

Under the new plan, barring significant safety issues, InVivo will submit two months of safety data to the FDA for the first subject enrolled in October, and will then open enrollment for the second subject in mid-January (about three months after the first subject was enrolled). Upon enrollment of the second subject, InVivo will submit to the FDA one month of safety data for that subject together with the previous subject’s data; concurrent enrollment for the remaining three subjects will then begin (about two months after the second subject is enrolled). There will be no additional mandatory holds between enrollment of the final three subjects. This differs from the previous plan, which required a mandatory three-month hold between sequential enrollment of each of the five subjects.

“Over the last calendar year, we have cultivated a collaborative and fruitful relationship with the FDA, and we couldn’t be happier with today’s announcement,” said Mark Perrin, InVivo’s CEO. “Under our new plan, it’s possible to reduce the duration of our pilot trial by up to one year. This, of course, is dependent on patient presentation, but with today’s approval, along with our previously-announced approval of increasing the number of clinical sites up to 20, we are much better positioned to execute and complete this trial in an expedited fashion. Although we cannot predict when subjects will present, we now anticipate full enrollment in the pilot trial in 2015.”

This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The investigational device exemption pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a humanitarian device exemption.

The biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound after an acute spinal cord injury and acts by appositional healing to spare spinal cord tissue, decrease post-traumatic cyst formation, and decrease spinal cord tissue pressure in preclinical models of spinal cord contusion injury.

Cambridge, Mass.-based InVivo Therapeutics Holdings Corp. was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital.