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Striking a ‘cord’ with spinal injuries
CAMBRIDGE, Mass.—InVivo Therapeutics Holdings Corp. and the University of Miami have entered into a five-year collaboration deal in order to co-develop spinal cord injury (SCI) treatments. InVivo is currently developing a biocompatible polymer scaffold for spinal injuries and intends to work with the Miami Project to Cure Paralysis at Miami's Miller School of Medicine to combine their technologies.
For the collaboration, InVivo and Miami plan to combine InVivo's biopolymer scaffold-based technology with Miami's Schwann cells, as well as other cellular therapies. Miami and InVivo will jointly own any intellectual property resulting from the research collaboration. Miami also agreed to give InVivo a right of first offer to an exclusive worldwide license to develop and commercialize any technology that results from the Miami Project.
"We are very pleased to form this partnership with InVivo Therapeutics and look forward to evaluating its innovative biopolymer scaffolding device," says Marc Buoniconti, president of the Miami Project.
InVivo's technology utilizes a biodegradable polymer designed to act as a synthetic extracellular matrix and to reduce astrogliosis, or scar formation. The scaffoldings mimic the natural protective properties of the extracellular matrix within the spinal cord and help to proliferate implanted cells and aid their survival. The scaffoldings also provide "neuroprotection for the spinal cord's cells by minimizing the effect of inflammation and bleeding after injury," according to Frank Reynolds, CEO of InVivo Therapeutics. Dr. W. Dalton Dietrich, III, scientific director of the Miami Project, says the scaffoldings "may serve to improve functional recovery and promote the proliferation and survival of cellular therapies such as Schwann cells at the site of injury."
The Schwann cells Miami will provide for the collaboration serve to form protective sheaths around motor and sensory neurons. The cells are part of the peripheral nervous system, and in addition to insulating nerve fibers, they also contribute to the fibers' growth and regeneration. Miami Project scientists have used preclinical models to demonstrate locomotor function recovery, spared nerve function and nerve cell growth utilizing autologous Schwann cell transplantation.
"We see significant potential in the natural synergies from combining these treatment approaches, both of which have been validated in preclinical studies," says Dietrich. "The Miami Project team looks forward to elucidating their potential and to working with InVivo toward our common goal of finding new and better treatments for spinal cord injury. "
The aim of the collaboration, according to Reynolds, is to "provide a faster path to human studies for patients with both acute and chronic SCI." The companies hope that by combining the protective nature of InVivo's biopolymer scaffolds and the regenerative capabilities of Miami's Schwann cells, they can determine the compatibility of the two technologies in humans and new advances in the field of SCI can be made.
There is no shortage of demand for new advances in the field. Reynolds says an estimated 12,000 new cases of SCI occur each year, and approximately 1.27 million people currently live with paralysis due to SCI. According to the National Spinal Cord Injury Statistics Center, cost of care can range from $321,720 to $985,774 for the first year, and the lifetime costs for someone injured at 25 can range from about $1.47 million to $4.37 million. Reynolds notes that InVivo "estimates a total addressable market for acute SCI for its first product of approximately $10 billion."
Both companies are working individually to further validate their respective technologies. Now that preclinical studies are complete, the Miami Project plans to file an Investigational New Drug application for a Phase I human study with Schwann cells. InVivo plans to begin a clinical study on its polymer scaffold-based spinal injury treatment during the second half of 2011. InVivo also plans to submit the scaffold treatment for U.S. Food and Drug Administration clearance alone, and might apply for additional clearances to use the scaffold device in conjunction with anti-inflammatory drugs or stem cell-based compounds.
"We have been working on the problem of SCI for more than 25 years and look forward to exploring another promising avenue in our quest to address the enduring need for effective treatment options," says Buoniconti. "The InVivo team shares our passion and personal commitment to finding new solutions to the challenges of spinal cord injury and paralysis."