InVivo Therapeutics, Geisinger Health System to Conduct Preclinical Study of Injectable Scaffold for Peripheral Nerve Injury For FDA Submission
CAMBRIDGE, Mass. and DANVILLE, Pa. (January 17, 2012) — InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), and Geisinger Health System today announced a research collaboration to conduct a preclinical study using InVivo’s injectable biocompatible hydrogel for the treatment of chronic pain caused by peripheral nerve compression. InVivo expects to submit data from the study to the U.S. Food and Drug Administration (FDA) in 2012 representing the Company’s first technology to treat degenerative neurologic conditions outside of the spinal cord.
Back and leg pain along with neck and arm pain arm amongst the top five most common reasons for physician visit worldwide. Patients with peripheral nerve compression often experience chronic pain, tingling and numbness in the extremities, and approximately 3,200,000 chronic pain injections are performed annually in the U.S. to treat these conditions. InVivo will leverage its SCI platform technology to provide time-released anti-inflammatory therapies to this estimated $15B annual market.
“Chronic peripheral nerve compression can have a devastating impact on an individual’s quality of life and even impair one’s ability to function on a day-to-day basis,” said Dr. Jonathan Slotkin, a renowned expert in spinal cord injury treatment and director of spinal surgery and spinal cord injury research at Geisinger Health System’s Neurosciences Institute. “InVivo’s innovative technology platform has already demonstrated success in the treatment of traumatic spinal cord injury in several study models, and we look forward to examining how this latest technology performs in this new application.”
The study will be conducted jointly in the Tapinos Lab of Molecular Neuroscience at the Weis Center for Research and the Slotkin Lab of Spinal Cord Injury Research at the Geisinger Clinic’s Neurosciences Institute. The endpoint of the study will be the effectiveness of using injectable hydrogels for the controlled release of drugs to alleviate chronic pain resulting from compression-induced peripheral nerve damage. The study will compare the resulting molecular and behavioral impact among rodents receiving the injectable scaffold with drug therapy, the injectable scaffold alone, injectable drug therapy alone and a control group receiving no injection.
“The Geisinger Neurosciences Institute is one of the premiere facilities in the country for the study of innovative diagnostic and treatment approaches to neurologic disorders,” said Dr. Ed Wirth, InVivo’s chief science officer and one of the world’s foremost experts in spinal cord injury treatment and regenerative medicine. “We believe there is tremendous potential for our technology to treat other neurological conditions beyond spinal cord injury, and we are eager to move forward in bringing these therapies one step closer to broad market availability.”
InVivo is currently awaiting FDA approval to commence the first human clinical study using its proprietary polymer scaffolding device to provide structural support to a damaged spinal cord to help prevent paralysis and improve recovery and prognosis for patients with acute spinal cord injury. The human study is expected to begin in 2012.