InVivo files biopolymer scaffold IDE with FDA to initiate spinal cord injury clinical trial

Jul 8 2011

InVivo Therapeutics (OTCBB: NVIV) today announced that the Company has submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) for a proprietary biopolymer scaffolding device to protect and support spinal tissue and prevent secondary injury, including inflammation and glial scarring, following traumatic spinal cord injury.

The Company has requested permission to initiate an open-label study of 10 patients with acute spinal cord injuries within several days of injury. As currently planned, patients will be enrolled in the pilot trial at sites in Boston and Washington, D.C. under Principal Investigators Eric Woodard, M.D., InVivo's Chief Medical Officer and Chief of Neurosurgery at New England Baptist Hospital, and Jonathan Slotkin, M.D., neurosurgeon at Washington Brain & Spine Institute. Patients will subsequently be transferred to a rehabilitation center and will be followed for one year.

The trial will evaluate safety data as the primary endpoint. Motor and sensory recovery, as determined by the American Spinal Injury Association (ASIA) Impairment Score, will also be assessed as secondary endpoints.

"InVivo's first regulatory submission for human testing is a major step forward in realizing the promise of our technology for spinal cord injury patients," said Frank Reynolds, Chief Executive Officer of InVivo Therapeutics. "While current procedures offer very little hope, we have seen evidence of functional recovery in our preclinical non-human primate studies that supports advancement to human trials. Our goal for this initial study is to safely minimize the secondary injury processes, thereby allowing the body to reorganize locally toward functional recovery through the spared healthy tissue. This process, known as neuroplasticity, may result in partial functional recovery."

The InVivo investigational device is a biopolymer scaffold implant that will be customized by a neurosurgeon to fit the spinal cord lesion, and then implanted into the patient's spinal cord. The scaffold biodegrades within the body at a controlled rate over approximately 12 weeks.

In addition to the scaffold, InVivo is developing and testing its second product, an injectable hydrogel intended as a minimally invasive option to deliver agents locally.