Two Additional Patients Implanted With InVivo’s INSPIRE Scaffold in Expanded Clinical Trial

InVivo Therapeutics Holdings Corp. has provided an update on the INSPIRE study of the Neuro-Spinal Scaffold.
 
Patient Enrollments
Tthe ninth and 10th patients have been implanted with the Neuro-Spinal Scaffold in the company’s INSPIRE study. The ninth patient received the implant at Vidant Medical Center, a Level 1 trauma center in Greenville, N.C. The procedure was performed by Vidant Medical Group neurosurgeons Stuart Lee, M.D., the principal investigator at the site, and Hilal Kanaan, M.D., approximately 40 hours after the injury occurred. “The implantation procedure went smoothly and the patient is doing well. We are excited to be a part of the INSPIRE study and look forward to following the patient’s progress” Lee said.
 
The 10th patient received the scaffold approximately 18 hours after the injury by Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, chief of neurosurgery at the Carolinas Medical Center (Charlotte, N.C.), and a member of the INSPIRE Study Steering Committee. Coric and Dr. William Bockenek, chief medical officer at Carolinas Rehabilitation, are co-principal investigators at this site. The 10th patient, however, died from a stroke several days after surgery. The cause of death was deemed by Coric and the chairman of the DSMB to be unrelated to the Neuro-Spinal Scaffold or the implantation procedure.
 
“We express our condolences to the family of the patient who passed away. Each loss of an individual with a spinal cord injury strengthens our resolve to develop and bring to market new treatments that will improve the lives of patients with these devastating injuries,” said InVivo CEO and Chairman Mark Perrin.
 
Expansion of INSPIRE Study
The INSPIRE study was initially approved to enroll 12 patients pending review of six-month safety data from the first five patients implanted with the Neuro-Spinal Scaffold. In addition to the 10 implanted patients, two patients were screen failures, which means the patients consented to participate in the study but failed to meet all of the inclusion and exclusion criteria of the study. Although these two screen failure patients were not implanted with the Neuro-Spinal Scaffold, they were technically enrolled into the INSPIRE study. Therefore, the study had enrolled 12 patients by the end of May (when the 10th patient was implanted by Coric) and the enrollment of additional patients required action from the U.S. Food and Drug Administration (FDA).
 
After reviewing the six-month safety data, the FDA requested minor modifications to the INSPIRE study protocol and informed consent documents. These modifications are being incorporated, and the FDA has approved the enrollment of additional patients to allow for 20 evaluable patients (with six months of follow up data) in the INSPIRE study. Because of the frequent interactions with the FDA over the last several weeks regarding relatively minor modifications, InVivo chose to postpone updates on the INSPIRE study until there was clarity regarding the path forward. “We are pleased that the FDA has approved expansion of the INSPIRE study that clears the way for enrolling all 20 evaluable patients,” Perrin said. “While the pause in enrollment for the last several weeks was unfortunate, this approval is an important step toward our goal of approaching full enrollment of the INSPIRE study by the end of the year.”
 
During the interactions regarding the expansion of the INSPIRE study, the FDA also recommended that InVivo include a control arm in the study as part of a study design consideration. “As is typical of the regulatory process, we have addressed a number of Study Design Considerations regarding the INSPIRE study and its pilot precursor study over the last two years. We have begun a constructive discussion with the FDA regarding this study design consideration, and we will provide an update if substantial changes are made to the study protocol,” Perrin said. “We continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a Humanitarian Device Exemption (HDE) application for marketing approval. Given the encouraging results that we have observed to date, we look forward to working with the FDA to complete the INSPIRE study as efficiently as possible.”
 
InVivo’s Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete T2-T12/L1 spinal cord injury in support of an HDE application for approval.
 
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
 
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., professor at the 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. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, Mass.