InVivo Therapeutics (OTC:NVIV) said it received the green light from safety monitors to reopen enrollment in a clinical study of its neuro-spinal scaffold for treating acute spinal cord injuries.
The clinical trial, InVivo’s 1st for the neuro-spinal scaffold, is intended to evaluate the safety and effectiveness of the device in patients who have sustained acute thoracic spinal cord injuries. The company plans to eventually enroll 5 patients in the study.
The trial’s Data Safety Monitoring Board OK’d the move after reviewing safety data collected from the study’s 1st patient, who was treated with the product in October. InVivo recently announced the FDA had approved modifications to the trial’s protocol that would help speed enrollment.
“It is gratifying to know that the 1st subject is doing well and we are pleased to be moving forward with our pilot study. Since enrolling the 1st subject, we have increased the number of clinical sites from 3 to 6, putting us in a much better position to enroll the 2nd subject. Although we cannot predict when subjects will present, we anticipate enrolling our 2nd subject more quickly than our 1st,” CEO Mark Perrin said in prepared remarks. "As we have already announced, once the 2nd 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 3 through 5 about 2 months after the 2nd subject is enrolled."
“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,” Perrin added.
InVivo hopes to run an additional pivotal study after this trial concludes to commercialize the product under a humanitarian device exemption from the FDA.
