Richard Toselli, M.D., president and CEO of InVivo, said, “We made a dedicated effort to efficiently activate strategic clinical sites during the first half of the year and are pleased with the resulting pace of enrollment to date, with our team maintaining focus on enrollment efforts and engagement at the site level. In addition, we appreciate the investigators’ support of this trial, which we believe has the potential to address a long unmet medical need for spinal cord injury patients.”
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 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.
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 the 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.