InVivo on the Verge of SCI Trial
Cambridge, Mass.-based InVivo Therapeutics Holdings Corporation has received an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to begin human studies for its biopolymer scaffold product. The technology was developed by InVivo for the treatment of acute, traumatic spinal cord injuries (SCI).
InVivo intends to start the first-in-man clinical study “in the next few months.” The study, which is expected to last approximately 15 months, will test the safety and performance of its biopolymer scaffold in five patients. According to InVivo, there are currently no treatment options approved by the FDA, or in clinical trials, to intervene directly in the spinal cord following SCI. The trial will be conducted at multiple U.S. hospitals, and efforts to gain Institutional Review Board approval at Massachusetts General Hospital in Boston, Mass., is already underway.
“It’s heartbreaking for all of us for it to take even a minute longer than necessary to begin human studies, and we’ve all heard of, or experienced, treatments that have proven to be unsafe,” said Frank Reynolds, InVivo CEO. “But when conducting a first-in-man study, it is imperative to take the time to get it right, because any mistakes can lead to years of lost time for the scientists and patients that follow.”
Reynolds explained how certain of the acute a chronic neurological problems that could be addressed with InVivo’s new technology are so rare—orphan diseases that have very low incidence rates—that there are very limited treatment options out there. In these situations, he said, “every day life can feel like there is no way out.” According to Reynolds, if the trial is successful, the technology platform could lead to next generation treatment options for conditions such as amyotrophic lateral sclerosis, multiple sclerosis and Parkinson’s disease. These treatments are predicted to include combination therapies that will be optimized with long-term release and localized delivery of agents or cells.
“Over the next month or so, we plan to finalize the details of our study, and we expect to have all data to the FDA by the end of 2014,” continued Reynolds. “We will be conducting an open label study, and so we look forward to keeping the public aware of its progress. As a historical first-in-man study, this trial marks the next phase in our corporate growth and begins our mission to maintain a collaborative relationship with the FDA. We’ve built a framework to optimize speed-to-market for our pipeline of technologies, and we’ll be working to commercialize over fifteen products in the next five years while remaining focused on mitigating patient risk and maximizing patient safety and benefit.”
The FDA recently approved a Humanitarian Use Device (HUD) designation request from InVivo for the technology; the approval allows the scaffold to be used for recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord. HUDs are reserved for devices designed to treat rare diseases or conditions. The HUD designation and clinical trial data are required to support a Humanitarian Device Exemption application to the FDA with the goal of commercializing the scaffold in the United States sooner than a pre-market approval would allow.
InVivo is focused exclusively on technology for the treatment of SCIs.