CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced the reopening of subject enrollment for the company’s ongoing Investigational Device Exemption (IDE) pilot study of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Barring significant safety issues, the final three subjects of this pilot trial will be enrolled concurrently and without mandatory safety hold between enrollment of each subject. To date, there have been no reported serious safety events related to the Neuro-Spinal Scaffold or the procedure to implant the Neuro-Spinal Scaffold with the study’s first and second subjects, and InVivo has been approved by FDA and the Data Safety Monitoring Board (DSMB) to move forward with the study. As specified in the study protocol, the DSMB is a committee of independent clinical research experts charged with examining the safety data accumulated during the trial.
Mark Perrin, InVivo’s CEO and Chairman, said, “I am pleased with the safety profile our Neuro-Spinal Scaffold exhibited in our first two subjects and that we are able to proceed with our pilot study. Despite a severe, multi-trauma injury that included a collapsed lung and resulted in a two day delay in spinal stabilization and Neuro-Spinal Scaffold implantation, the second subject has not experienced any serious safety events to date related to our investigational product. Although we cannot predict when subjects will present, we anticipate enrolling subjects three through five this calendar year, which would complete enrollment for the pilot trial. What’s exciting about this reopening of enrollment is that we can now enroll the final patients concurrently, and we now have eight active clinical sites that can participate in this trial.”
The eight active clinical sites that will be open for enrollment today are:
- Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, MO
- Barrow Neurological Institute, Phoenix, AZ
- Carolina Neurosurgery & Spine Associates, Charlotte, NC
- Froedtert & the Medical College of Wisconsin, Milwaukee, WI
- Keck Hospital of University of Southern California, Los Angeles, CA
- Oregon Health & Science University, Portland, OR
- University of Arizona Medical Center, Tucson, AZ
- University of Pittsburgh Medical Center Presbyterian, Pittsburgh, PA
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
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 acts 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 designation and is currently being studied in an IDE pilot study for the treatment of 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, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, 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. 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 enrollment of additional patients in the scaffold pilot study following the reopening of enrollment and the company’s ability to conduct a second pivotal 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 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.