InVivo Therapeutics Holdings Corp. (NVIV) , a pioneering biomaterials company with unique technologies for drug delivery with a focus on treatment of spinal cord injuries, today confirmed that the company expects that the clinical trial of its first investigational product, a degradable polymer scaffold designed to promote healing following acute spinal cord injury , will be ready to enroll patients in the first quarter of 2014.
For the scaffold trial, InVivo will submit a filing containing proposed changes to its FDA-approved protocol and supporting documents within the next ten days. An FDA guidance document provides that the agency will try to respond to such filings within thirty days. The company believes that approval of the proposed changes would accelerate the progress of its trial by eliminating barriers to enrollment and by expanding the number of sites from at least three to as many as six. For instance, the proposed changes would eliminate a substantial amount of burdensome paperwork and other requirements unnecessary for a safety study.
The company has signed confidentiality agreements with more than ten qualified sites considering participation in the human safety study. All three members of an independent data safety monitoring committee have agreed to serve. In light of the increased need for scaffold inventory based both on the increased number of sites and the staggered enrollment required by the FDA, InVivo has for approximately a month diverted personnel, primarily engineers from its hydrogel product development program, into an effort to accelerate previous plans to manufacture scaffold product in-house. The company expects that this effort will be complete in February, and that its completion will give the company greater ability to control the quantity, quality and cost of its scaffold.
Most work on the InVivo hydrogel product development programs has been temporarily suspended due to the company’s focus on the scaffold manufacturing initiative as well as a review of its portfolio. As a result of this review, it has decided to focus its efforts more intently on strategic corporate partnerships that would create the greatest value for patients and shareholders regardless of therapeutic area. The company has entered into discussions with a number of prospective corporate partners based on this new business model, but it is premature at this time to estimate timelines or therapeutic areas.
Interim Chief Executive Officer Michael Astrue said, "I am grateful for the hard work of our employees and partners for supporting our recent strategic changes and for keeping our lead program on track. We are excited about the potential of our hydrogel drug delivery platform given its ability to release both small molecules and proteins over at least several weeks to parts of the body that need it most, and we are eager to talk to major companies whose products would benefit by accessing our technology."
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. focuses on utilizing polymers as a platform technology to develop treatments for serious diseases and conditions, including improving function in individuals paralyzed as a result of traumatic spinal cord injury. 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, M.D., who 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. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties, and include statements regarding the Company’s expectations with respect to the commencement of human clinical trials for the scaffold product, the timing of the submission of its revised protocol to the FDA, the impact that the revised protocol would have on the progress of the clinical trials, the impact of the Company’s efforts with respect to the manufacturing of the scaffolds and possible partnerships for its hydrogel product. The 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 obtain FDA approval of its revised protocol and the timing thereof; the identification of appropriate clinical sites; the Institutional Review Board process; the Company’s ability to enter into partnerships; 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 our filings with the SEC, including our Form 10-K and 10-Qs and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.
