Health Canada has approved Invivo Therapeutics’ Investigational Testing Authorization application to commence a clinical study of the Neuro-spinal scaffold in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries.
InVivo is currently in late-stage conversation with several site Research Ethics Boards and expects to announce its first Canadian site in the coming weeks, according to a company release.
Mark Perrin, chief executive officer of the company says, “Moving into the cervical spinal cord is exciting, since each level of the cervical spinal cord has a substantial functional impact. If the Neuro-spinal scaffold were able to preserve, remyelinate and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences. We look forward to bringing sites onboard in Canada to commence enrolment and ultimately to expanding our study of cervical patients to the UK and the USA.”
Invivo has also announced that it has submitted its first module containing nonclinical studies to the US Food and Drug Administration (FDA) as part of its Humanitarian Device Exemption (HDE) modular submission and review process for the Neuro-spinal scaffold.
The company’s modular HDE process is based on a submission of three modules to the FDA that constitute a complete HDE submission once all have been submitted: a nonclinical studies module, a manufacturing module, and a clinical data module. This process allows the FDA to review each module separately and provide timely feedback, typically within 90 days of submission, thereby allowing the applicant the opportunity to resolve any deficiencies earlier in the review process compared to a traditional HDE application.
“We expect to receive acceptance of the nonclinical module in the third quarter of this year, and plan to submit the manufacturing module in the second half of 2017 and the clinical module in 2018, all as part of our strategy to pursue accelerated approval for the Neuro-spinal scaffold,” says Perrin.
The company have also announced that a new patient has been enrolled into the INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) at the Cooper Neurological Institute (CNI), Cooper University Hospital, Camden, USA.
Steven Yocom, assistant professor of Neurosurgery, director of the CNI Spine Program and principal investigator at this site, performed the implantation approximately 29 hours after the injury occurred.
“The implantation procedure was a success, and the patient is recovering well,” Yocom commented. “We are excited to be part of the INSPIRE study and look forward to following the patient’s progress.”