Neuro-Spinal Scaffold for Repair of Spinal Cord Injuries: Interview with InVivo CEO
Medgadget
SEPTEMBER 25TH, 2015 RACHEL KESSLER
http://www.medgadget.com/2015/09/neuro-spinal-scaffold-repair-spinal-cord-injuries-interview-invivo-ceo.html
InVivo Therapeutics, a company in Cambridge, MA, is developing a new way to treat patients with acute thoracic spinal cord injuries, a patient population that has never had any viable therapeutic options for recovery. We caught up with Mr. Mark Perrin, CEO and Chairman of the Board of InVivo Therapeutics, who took over leadership of the company last year on a mission to fill that treatment void and become the leader in developing innovative products for spinal cord injury.
Rachel Kessler, Medgadget: I understand that the new treatment you are advocating could potentially change the standard of care for spinal cord injury (SCI) patients. What is this new treatment?
Mark-PerrinMr. Perrin: The new treatment includes both a new surgical approach as well as the use of our Neuro-Spinal Scaffold. Following the injury, a myelotomy (surgical incision of the spinal cord) is performed to remove the liquefied necrotic material, which both reduces the pressure in the spinal cord and creates a cavity for our Neuro-Spinal Scaffold. The Neuro-Spinal Scaffold is a biomaterial based on proprietary technology developed by MIT professor Dr. Robert Langer. The Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound. Once the scaffold is surgically implanted it is designed to act as a physical substrate to promote neural repair. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. Further, the scaffold safely biodegrades within the body over the time course of weeks to months.
Medgadget: Tell us about the clinical study for acute spinal cord injuries. What is your development plan?
Mr. Perrin: We have enrolled five patients in our initial pilot trial, which was the original clinical plan approved by the FDA. Given our progress, we will continue to enroll patients under the Emergency Use Expanded Access Mechanism on a case-by-case basis, and the safety and outcomes data from these patients will be included in our application for approval. Furthermore, we have also filed an amendment with the FDA to expand the number of patients in the pilot trial. Finally, we are in discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study patients and the Emergency Use patients into the pivotal probable benefit study. We expect to use this single study as the basis for our Humanitarian Device Exemption (HDE) application for product approval, which would allow us to dramatically reduce the time to approval and commercialization.
Medgadget: Sounds like this is showing great promise.
Mr. Perrin: Yes, the first three patients treated with the Neuro-Spinal Scaffold have already experienced significant improvement in motor, sensory, and bowel and/or bladder function. Severity of injuries are measured by specific classifications with complete paralysis being classified as AIS A, which indicates no motor or sensory function below the level of injury. The first of our treated patients with a lower thoracic injury went from AIS A to AIS C at one month, which happens in only about five percent of patients according to the large U.S. and European databases and indicates preserved motor and sensory function below the level of injury. Our third patient with a high thoracic injury went from AIS A to AIS B with preserved sensory function below the level of injury at one month which happens in only about four percent of patients. This is extremely promising as the probability for two out of three patients to make these AIS grade conversions is less than one percent. Our goal is to address the underlying pathology following acute SCI to develop treatment modalities that aim to preserve reversibly injured tissue, heal damaged tissue and ultimately restore function. So far, our initial clinical results are promising.
Medgadget: What’s in the future for InVivo?
Mr. Perrin: We are planning to initiate a clinical plan for cervical spinal cord injury patients with complete paralysis. Following that we plan to conduct a study in those patients with a spinal cord injury that results in partial or incomplete paralysis. Lastly, at the research stage, we are investigating the use of biomaterials with neural stem cells for the 275,000 chronic SCI patients.
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
Medgadget
SEPTEMBER 25TH, 2015 RACHEL KESSLER
http://www.medgadget.com/2015/09/neuro-spinal-scaffold-repair-spinal-cord-injuries-interview-invivo-ceo.html
InVivo Therapeutics, a company in Cambridge, MA, is developing a new way to treat patients with acute thoracic spinal cord injuries, a patient population that has never had any viable therapeutic options for recovery. We caught up with Mr. Mark Perrin, CEO and Chairman of the Board of InVivo Therapeutics, who took over leadership of the company last year on a mission to fill that treatment void and become the leader in developing innovative products for spinal cord injury.
Rachel Kessler, Medgadget: I understand that the new treatment you are advocating could potentially change the standard of care for spinal cord injury (SCI) patients. What is this new treatment?
Mark-PerrinMr. Perrin: The new treatment includes both a new surgical approach as well as the use of our Neuro-Spinal Scaffold. Following the injury, a myelotomy (surgical incision of the spinal cord) is performed to remove the liquefied necrotic material, which both reduces the pressure in the spinal cord and creates a cavity for our Neuro-Spinal Scaffold. The Neuro-Spinal Scaffold is a biomaterial based on proprietary technology developed by MIT professor Dr. Robert Langer. The Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound. Once the scaffold is surgically implanted it is designed to act as a physical substrate to promote neural repair. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. Further, the scaffold safely biodegrades within the body over the time course of weeks to months.
Medgadget: Tell us about the clinical study for acute spinal cord injuries. What is your development plan?
Mr. Perrin: We have enrolled five patients in our initial pilot trial, which was the original clinical plan approved by the FDA. Given our progress, we will continue to enroll patients under the Emergency Use Expanded Access Mechanism on a case-by-case basis, and the safety and outcomes data from these patients will be included in our application for approval. Furthermore, we have also filed an amendment with the FDA to expand the number of patients in the pilot trial. Finally, we are in discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study patients and the Emergency Use patients into the pivotal probable benefit study. We expect to use this single study as the basis for our Humanitarian Device Exemption (HDE) application for product approval, which would allow us to dramatically reduce the time to approval and commercialization.
Medgadget: Sounds like this is showing great promise.
Mr. Perrin: Yes, the first three patients treated with the Neuro-Spinal Scaffold have already experienced significant improvement in motor, sensory, and bowel and/or bladder function. Severity of injuries are measured by specific classifications with complete paralysis being classified as AIS A, which indicates no motor or sensory function below the level of injury. The first of our treated patients with a lower thoracic injury went from AIS A to AIS C at one month, which happens in only about five percent of patients according to the large U.S. and European databases and indicates preserved motor and sensory function below the level of injury. Our third patient with a high thoracic injury went from AIS A to AIS B with preserved sensory function below the level of injury at one month which happens in only about four percent of patients. This is extremely promising as the probability for two out of three patients to make these AIS grade conversions is less than one percent. Our goal is to address the underlying pathology following acute SCI to develop treatment modalities that aim to preserve reversibly injured tissue, heal damaged tissue and ultimately restore function. So far, our initial clinical results are promising.
Medgadget: What’s in the future for InVivo?
Mr. Perrin: We are planning to initiate a clinical plan for cervical spinal cord injury patients with complete paralysis. Following that we plan to conduct a study in those patients with a spinal cord injury that results in partial or incomplete paralysis. Lastly, at the research stage, we are investigating the use of biomaterials with neural stem cells for the 275,000 chronic SCI patients.
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110