InVivo Therapeutics Announces Approval for INSPIRE Pivotal Probable Benefit Clinical Study of the Neuro-Spinal Scaffold(TM)
CAMBRIDGE, Mass. / CRWEPRESSRELEASE / January 4, 2016 - InVivo Therapeutics Holdings Corp. (NVIV) announced that it has received approval of a protocol amendment from the U.S. Food and Drug Administration (FDA) that will convert its ongoing pilot study into a pivotal probable benefit study. Prior to this announcement, the approval was conditional solely upon a minor change to the informed consent form.
With this transition, the study will be known formally as “The INSPIRE 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.” The INSPIRE Study is designed to enroll 20 implanted patients, inclusive of the five patients already enrolled in the study.
The INSPIRE study is currently approved to enroll up to 12 patients, but InVivo expects that the FDA will approve the full 20 patients following the review of the complete 6-month data package for the first five patients. The company plans to submit these data in the second quarter of 2016.
An objective performance criterion (OPC) for the study to support probable benefit using historical benchmarks is under discussion with the FDA. In large European and US databases, the published rates of spontaneous improvement of at least one AIS grade in complete (AIS A), thoracic SCI patients at 6 months are less than 16%. An additional study protocol amendment may be required to establish the OPC.
“Receiving full approval to convert our pilot study into a pivotal probable benefit study is a significant step forward for InVivo,” said Mark Perrin, Chief Executive Officer and Chairman. “It is extraordinary to think that just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the intent to file an application for HDE approval in just two years.”
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
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. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. 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," “designed to,” “potentially,” and similar expressions, and include statements regarding the expected timing of the FDA’s full approval of further enrollment in the study, the expected timing of submission of data from the study to the FDA, planned international expansion and expected timing of filing an application for HDE approval. 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 modify its pilot trial protocol or to conduct a future study; the company’s ability 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 the treatment of 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 Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
Source: InVivo Therapeutics Holdings Corp.