InVivo Therapeutics Holdings Corp. has gained the agreement of the U.S. FDA to expedite enrollment for its ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.
This story revolves around InVivo Therapeutics degradable polymer Neuro-Spinal Scaffold and its tortuous progress to market. Specifically it’s about a planned IDE pilot study, intended to capture preliminary safety and effectiveness data 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.
If you track InVivo’s share price for the past two years you’ll spot the moment when its clinical study plan suddenly bore down on the company’s prospects. As we reported last August (2013), the FDA demanded that a study that InVivo had proposed would involve simultaneous patient treatments, was actually to see them treated and followed up sequentially, three months at a time. The impact on the timeframe to complete the study was calamitous, and the fallout significant.
Under the newly modified, and indeed approved 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.
Mark Perrin, InVivo’s CEO, said, “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. 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.”
Source: InVivo Therapeutics Holdings Corporation, Business Wire