“Having the first two patients enrolled into the INSPIRE 2.0 Study is a critical milestone for the company and for the spinal cord injury patient population, as there continues to be inadequate treatment options for these patients. With eight clinical sites now open for enrollment, we remain optimistic about continuing to execute on the INSPIRE 2.0 study and will provide updates when appropriate,” commented Richard Toselli, M.D., president and CEO of InVivo.
The INSPIRE 2.0 Study is a two-arm 20-patient (10 subjects in each study arm), randomized, controlled trial designed to provide clinical data that will supplement the existing clinical results from the company’s previous single-arm study (INSPIRE 1.0). The definition of study success for the INSPIRE 2.0 Study is that the difference in the proportion of subjects who demonstrate an improvement of at least one grade on ASIA Impairment Scale (AIS) assessment at the six-month primary endpoint follow-up visit between the Scaffold Arm and the Comparator Arm must be equal to or greater than 20 percent.
“We appreciate the investigators’ continued focus and willingness to support not only this trial, but also this underserved patient population. Ultimately, we hope to address a large unmet medical need for spinal cord injury patients,” concluded Dr. Toselli.
INSPIRE 1.0 Study Results
As previously announced by InVivo, seven of 16 (44 percent) patients who reached the six-month primary endpoint visit in the INSPIRE 1.0 Study had an AIS conversion at six months, which is the primary endpoint of the INSPIRE 1.0 Study (defined as improvement in AIS grade from baseline for all evaluable patients at the six-month visit). Altogether, 19 patients were implanted with the Neuro-Spinal Scaffold in the INSPIRE 1.0 Study, which is officially closed. Three patients died within two weeks of implantation, each death deemed unrelated to the Neuro-Spinal Scaffold or implantation procedure by the respective site’s principal investigators. The Objective Performance Criterion (study success definition) for the INSPIRE 1.0 Study was a 25 percent AIS conversion rate based on the published conversion rates for thoracic spinal cord injury reported in the literature.
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 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. The publicly traded company is headquartered in Cambridge, Mass.