InVivo Therapeutics has announced approval from the US Food and Drug Administration (FDA) for an expedited enrolment 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 enrolment for the second subject in mid-January (about three months after the first subject was enrolled).
Upon enrolment 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 enrolment 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 enrolment of the final three subjects. This differs from the previous plan, which required a mandatory three-month hold between sequential enrolment of each of the five subjects.
Mark Perrin, InVivo’s chief executive officer, says: “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 enrolment in the pilot trial in 2015.”
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE 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 commercialisation under a humanitarian device exemption.