UPDATED July 14, 2016, with news of 1st Canadian trial site.
Just a day after the FDA approved the expansion of the Inspire study of its neuro-spinal scaffold, InVivo Therapeutics (NSDQ:NVIV) said Health Canada granted investigational testing authorization for the study. Today the company said the Toronto Western Hospital’s Research Ethics Board approved its participation in the trial.
“The Canadian scientific and medical community recognizes spinal cord injury as a significant unmet medical need and has been at the forefront of researching potential therapies for years,” chairman & CEO Mark Perrin said yesterday in prepared remarks. “Partnering with countries and institutions that share our commitment to advancing the field is a significant step in furthering the company’s global mission: To redefine the life of the spinal cord injury patient.”
Cambridge, Mass.-based InVivo said Dr. Michael Fehlings was named principal investigator at the site.
“We are pleased to welcome Dr. Fehlings, one of the global leaders in spinal cord injury research, and the Toronto Western Hospital to the Inspire study,” Perrin said today.
“Spinal cord injury is a devastating condition for which innovative bioengineered regenerative strategies hold considerable promise. Accordingly, our centre is pleased to assist with translating this exciting technology for people with paralysis from spine trauma into the clinic,” added Fehlings.
In the U.S., the FDA approved the expansion of the Inspire trial to up to 20 patients. Ten patients have been implanted with the InVivo device, a surgical implant designed to act as a physical substrate for nerve sprouting after acute spinal cord injuries. The 10th patient in the trial died of a stroke that was unrelated to the InVivo device implantation, the company said this week.
Last month, InVivo touted a case study of the 1st implantation of its spinal scaffold published in Neurosurgery, the journal of the Congress of Neurological Surgeons. The case involved a 25-year-old man with an American Spinal Injury Assn. Grade A spinal cord injury sustained in a motocross accident. Dr. Nicholas Theodore implanted an InVivo spinal scaffold directly into the traumatic cavity.
After 3 months, the patient had improved to a Grade C incomplete injury, according to the study, and at 6 months there were no procedural complications or safety issues related to the device. InVivo has said that the patient demonstrated an 8-point gain on the 50-point AIS lower extremity motor score and additional bilateral motor function improvements between the 6-month and 12-month follow-ups.
In December 2015, InVivo won conditional approval from the FDA to convert its the ongoing pilot study to a pivotal probable benefit study, allowing the company a faster path to FDA approval. Earlier this year the company raised a $32 million funding round.
