InVivo Therapeutics is reopening subject enrollment for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury.
Back in December InVivo announced that it had gained the agreement of the U.S. FDA to somewhat shorten the gap between subject enrollment from the original demands from the agency, to two months, for the second patient. Then, subject to no adverse clinical findings, concurrent recruitment of the final three would start some two months after the recruitment of subject number two.
The good news is that there have been no reported serious safety events with the study’s first subject, so InVivo has been cleared by the Data Safety Monitoring Board (DSMB) to move forward with the study.
This pilot study is intended to capture preliminary safety and effectiveness data of InVivo’s Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The company then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
Mark Perrin, InVivo’s CEO, said, “It is gratifying to know that the first subject is doing well and we are pleased to be moving forward with our pilot study. Since enrolling the first subject, we have increased the number of clinical sites from three to six, putting us in a much better position to enroll the second subject. Although we cannot predict when subjects will present, we anticipate enrolling our second subject more quickly than our first.
As we have already announced, once the second subject is enrolled, the FDA will require only 30 days of safety data for that subject, rather than 90 days, before reopening enrollment. Barring any significant safety issues, we anticipate reopening the study for concurrent enrollment of subjects three through five about two months after the second subject is enrolled,” Perrin said. “In parallel, we are taking full advantage of a previous FDA approval and are making significant progress to increase the number of participating clinical sites up to 20.”
Source: InVivo Therapeutics Holdings Corp.