InVivo Therapeutics (NSDQ:NVIV) said today that the 9th spinal cord injury patient, implanted with its neuro-spinal scaffold last month, is already showing signs of improvement.
InVivo’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The 9th patient in a clinical trial improved from a complete to incomplete spinal cord injury on the American Spinal Injury Assn.’s 50-point lower extremity motor score between the 2nd and 3rd month after implantation, Cambridge, Mass.-based InVivo said. The patient is the 5th of 8 patients in the company’s Inspire study to show an AIS grade improvement, InVivo said.
In June, InVivo touted a case study of the 1st patient, showing improvement at 3 months to a Grade C incomplete injury and no procedural complications or safety issues at 6 months. That patient demonstrated an 8-point gain in AIS score and additional bilateral motor function improvements between the 6-month and 12-month follow-ups.
All told, patients in the Inspire study showed a 62.5% conversion rate in AIS scores; the trial’s objective performance criterion is a conversion rate of 25% at 6 months.
“Having 5 patients improve AIS grades so early in the Inspire study is a fantastic achievement and a major milestone for InVivo,” chairman & CEO Mark Perrin said in prepared remarks. “If we continue to observe AIS conversions at a similar rate, we will dramatically exceed the objective performance criterion measure of study success. Our current conversion rate is 4 times the rate in natural history databases, which is extremely encouraging. We look forward to completing the Inspire study as quickly as possible and applying for [a humanitarian device exemption from the FDA] in 2017.”
“The evidence obtained to date in the Inspire study is tremendously encouraging. It has been rewarding to be involved in the study and to observe this patient’s recovery to date, and I hope that the patient continues to make progress,” added Dr. Stuart Lee of Vidant Medical Center in Greenville, N.C.
In July, InVivo said the FDA cleared an expansion of the Inspire study to up to 20 patients and announced the 9th and 10th implantations in the trial (the 10th patient died of an unrelated stroke, the company said last month).
NVIV shares jumped 12.8% to $6.97 apiece in late-morning trading today.
