CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that the first two patients have been enrolled into The INSPIRE 2.0 Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury).
“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 Chief Executive Officer 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%.
“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, 7 of 16 (44 percent) patients who reached the six-month primary endpoint visit in the INSPIRE 1.0 Study had an AIS conversion at 6 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.
About InVivo Therapeutics
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, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” and similar expressions, and include statements regarding the expectations related to continued updates from the INSPIRE 2.0 Study. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to obtain FDA approval to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, and its other filings with the SEC, including the Company’s Form 10-K, Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.