With this approval, InVivo intends to commence a first-in-man clinical study in the next few months that will test safety and performance of its biopolymer scaffold in five patients. The Company expects the study to occur over approximately 15 months. 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 work to gain Institutional Review Board (IRB) approval at Massachusetts General Hospital in Boston 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, 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,” said Frank Reynolds, InVivo Chief Executive Officer.
“I want to thank my team for their years of dedication and hard work, and the FDA for its diligence, careful consideration and engagement during the stringent review of our technology, a true platform that we believe is capable of being leveraged into new treatments for a wide range of acute and chronic neurological conditions. Many of these neurological problems have limited options for care, and for the patients and families of those with lower incidence conditions, often called ‘orphan’ conditions, every day life can feel like there is no way out. We expect a successful safety study to provide not only the first treatment for acute SCI, but also a safe platform for next generation treatment options for conditions such as ALS, MS and Parkinson’s Disease. At InVivo we live by the mantra ‘What a drug or cell can do…We can optimize,’ and we believe that these treatments will include combination therapies that will be optimized with long-term release and localized delivery of agents or cells.”
Continued Reynolds, “Everyone knows my obsession with safe FDA studies. 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. 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 Company was also recently granted approval from the FDA on its Humanitarian Use Device (HUD) designation request. HUD designation is reserved for devices designed to treat rare diseases or conditions. InVivo has received this designation for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord. The HUD designation and clinical trial data are required to support a Humanitarian Device Exemption (HDE) application to the FDA with the goal of commercializing the scaffold in the United States sooner than a Pre-Market (PMA) approval would allow.