Study to Include Reeve Foundation North American Clinical Trials Network (NACTN) Registry
InVivo Therapeutics Holdings Corp. (NVIV) today announced that data from the Christopher & Dana Reeve Foundation NACTN Registry will be included in the Contemporary Thoracic SCI Registry Study (now called the “CONTEMPO Registry Study”), a complement to the ongoing INSPIRE study of the Neuro-Spinal Scaffold™. The CONTEMPO Registry Study is intended to provide comprehensive natural history benchmarks for INSPIRE study results that include spinal cord injury (SCI) patients with similar baseline characteristics treated since 2006. The NACTN registry is derived from a network of academic neurosurgical departments of hospitals that have a strong focus on SCI, especially in the acute injury phase. The NACTN Registry includes acute patient data such as pre- and post-operative data, post-injury complications and treatments, MRI data, and follow-up neurological exams. Because the NACTN registry contains acute care data, it will allow for the close matching of registry patient characteristics with INSPIRE inclusion and exclusion criteria, and will be highlighted in the CONTEMPO Registry Study as a well matched natural history benchmark comparator for INSPIRE results.
The CONTEMPO Registry Study will provide a robust evaluation of the recent natural history of acute, complete thoracic SCI patients across North American and European populations. InVivo has submitted a protocol for the CONTEMPO Registry Study to the U.S. Food and Drug Administration (FDA) and does not expect this study to affect clinical or regulatory timelines. InVivo believes that the combined information in the INSPIRE study and the CONTEMPO Registry Study will provide a rigorous body of evidence for the demonstration of safety and probable benefit as required by the Humanitarian Device Exemption (HDE) approval process, and plans to submit the two studies together for HDE approval.
James Guest, M.D., Ph.D., a member of InVivo’s Scientific Advisory Board, a NACTN investigator, and the Principal Investigator of the CONTEMPO Registry Study, said, “The NACTN Registry was developed in large part to aid in the interpretation of SCI clinical trial results. This is the first time that the registry will be used with a partner in industry, and I believe that the registry will provide a valuable benchmark for analysis of INSPIRE results.”
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, added, “We are grateful for the care and vigilance that NACTN has put into developing an impressively thorough, curated database over many years. The inclusion of the NACTN Registry substantially increases the strength of the CONTEMPO Registry Study. We look forward to completing the INSPIRE study and the CONTEMPO Registry Study and submitting the results together in 2018 in an application for HDE approval of the Neuro-Spinal Scaffold.”