The FDA approved an expedited enrollment plan for a 5-patient pivotal study testing InVivo Therapeutics‘ (OTC:NVIV) neuro-spinal scaffold for treating severe spinal cord injuries.
Under the new plan, InVivo will submit 2 months of safety data for the 1st patient in the study, who was enrolled last October. The company plans to open enrollment for a 2nd patient in January, followed by 3 more patients 2 two months later.
The new plan differs from the previous plan in that there will be no mandatory 3-month holds between enrollments.
“Under our new plan, it’s possible to reduce the duration of our pilot trial by up to 1 year. This, of course, is dependent on patient presentation, but with today’s approval, along with our previously-announced approval of increasing the number of clinical sites up to 20, we are much better positioned to execute and complete this trial in an expedited fashion. Although we cannot predict when subjects will present, we now anticipate full enrollment in the pilot trial in 2015,” CEO Mark Perrin said in prepared remarks.
InVivo said the study is aimed at gathering preliminary safety and effectiveness data on the device, which is designed be used to treat patients with acute thoracic spinal cord injuries. The company then hopes to run a 2nd pivotal trial before seeking a humanitarian device exemption from the FDA.
InVivo’s shares soared in mid-November after doctors confirmed they had treated the 1st patient in the study, a 25-year-old Arizona man who sustained a severe spinal cord injury in a dirt-bike accident in October.
NVIV shares were up 3.7% to $1.12 apiece today as of about 1 p.m. Eastern.