InVivo Therapeutics Announces Fifth Patient Conversion in INSPIRE Study of the Neuro-Spinal Scaffold
Business Wire August 17, 2016
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
InVivo Therapeutics Holdings Corp. (NVIV) today 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. 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 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.
“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 Objective Performance Criterion (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.”
The 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.
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