InVivo Therapeutics has pioneered a new spinal cord repair scaffold, and back in January we covered the news that the FDA had approved a safety study. Now the company tells us it has begun shipping product, ready for the commencement of what will be its first U.S. clinical trial.
Readers may recall the hoo haa last year when the FDA told InVivo it wanted patients to be staggered rather than simultaneous. That demand provoked all kinds of trouble at the company, but now, less than a year later, they’re almost ready for the off and have shipped product for treatment of the first of five planned patients.
The company estimates the potential worldwide market for treating acute complete SCI to be over $500 million annually, and the chronic SCI market to be over $10 billion. There currently is no effective treatment for paralysis caused by SCI, making this first in-human trial a critical step in addressing this major unmet need.
InVivo Therapeutics’ Neuro-Spinal Scaffold for spinal cord injury (SCI) patients is a biocompatible polymer-based device that is intended to promote structural support for spinal cord regeneration while improving functional recovery and prognosis after a traumatic Spinal Cord Injury (SCI).
In preclinical studies, the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function.
This first clinical study, which is approved by the FDA, is a pilot trial to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The Company then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
The initial clinical site, The University of Arizona Medical Center in Tucson, AZ, has received Institutional Review Board (IRB) approval and has executed all necessary contracts with InVivo. Surgical training will occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrollment.
InVivo has received IRB approval from two additional sites and expects these two sites to be open for enrollment in the second quarter.
Ali A. Baaj, MD, Assistant Professor of Surgery and Director of the Spinal Neurosurgery Program at The University of Arizona Medical Center, is the Principal Investigator. In commenting about the significance of this trial, Dr. Baaj said: “Spinal cord injury research is a priority for us at the University of Arizona Spinal Neurosurgery program. We are excited to collaborate with InVivo Therapeutics on this groundbreaking clinical trial as we strive to help patients who are affected by this devastating condition.”
“The InVivo team has put forth a tremendous effort to bring this innovative product to the clinic,” InVivo CEO Mark Perrin said. “I anticipate continued momentum as additional sites are initiated in this important study. We are dedicated to patients whose lives have been forever changed by their traumatic injury. InVivo’s Neuro-Spinal Scaffold technology may again change their lives … this time for the better.”
Source: InVivo Therapeutics, Inc., Business Wire