Getting on for two years since it gained the FDA’s nod to start a patient study, InVivo Therapeutics Holdings Corp. updates us with positive clinical news.
Background
Following acute spinal cord injury, surgical implantation of InVivo’s 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 INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic “American Spinal Injury Association Impairment Scale” (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 a Humanitarian Device Exemption (HDE) application for approval.
Now InVivo Therapeutics has announced that the ninth patient implanted with the Neuro-Spinal Scaffold™ in the INSPIRE study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between the two- and three-month evaluations. This is the fifth out of the eight patients (62.5% conversion rate) in follow-up to have had an AIS grade improvement to date. To place the results in context, several large natural history databases indicate that fewer than 16% of patients with complete thoracic injuries have an AIS grade improvement by six months post-injury. Historical conversion rates are lowest for patients with high thoracic (T2-T5) injuries, with fewer than 8% of patients converting by six months post-injury. The neurological level of injury for this patient was T4.
The Objective Performance Criterion (OPC) measure of success for the INSPIRE study is defined as five (25%) or more of 20 evaluable patients in the study having improved by at least one AIS grade at the six months post-implantation assessment. If all five converted patients to date do not revert to AIS A before reaching the six month assessment and are deemed evaluable at the end of the study, then the OPC will have been met.
Investigator comments
“The evidence obtained to date in the INSPIRE study is tremendously encouraging. It has been rewarding to be involved in the study and to observe this patient’s recovery to date, and I hope that the patient continues to make progress,” said Stuart Lee, M.D. Dr. Lee, Principal Investigator at Vidant Medical Center in Greenville, NC performed the ninth patient implantation procedure.
Company comments
“Having five patients improve AIS grades so early in the INSPIRE study is a fantastic achievement and a major milestone for InVivo,” said Mark Perrin, Chief Executive Officer and Chairman. “If we continue to observe AIS conversions at a similar rate, we will dramatically exceed the OPC measure of study success. Our current conversion rate is four times the rate in natural history databases, which is extremely encouraging. We look forward to completing the INSPIRE study as quickly as possible and applying for an HDE in 2017.”
Source: Business Wire
published: August 18, 2016 in: Clinical Studies/Trials, Spine