=InVivo (NVIV) halts trial of spine injury treatment after third patient dies

InVivo Therapeutics said Monday it has halted a trial of its spinal cord injury treatment after a third patient died, sending shares of the Cambridge company plummeting.

InVivo (Nasdaq: NVIV) announced that it would temporarily stop enrolling patients in the trial of its Neuro-Spinal Scaffold, a biodegradable device invented in part by MIT professor Bob Langer designed to help patients heal after spinal cord injuries. The company said that the most recent patient to enroll in the study had died after being implanted in late June and then discharged from the hospital, marking the third time that a patient in the trial has died.

InVivo said Monday that none of the deaths were related to the device or the implantation procedure. Still, the company said it decided the halt the trial while it discusses with the FDA whether to change the enrollment criteria, including potentially restricting patients “who may have a higher mortality risk.”

Even as it announced a third patient death in the trial, dubbed Inspire, the company said that two more patients had met the primary goal of the study: being “converted,” or having their condition upgraded on a five-point scale, six months after implantation. So far, 6 of 11 patients have achieved that goal, InVivo said.

Due to the patient’s death, the company now expects to complete enrollment in the first half of 2018, and apply to market the scaffold under a so-called "humanitarian device exemption" in the second half of 2018.

Update on Patient Conversions 

• A patient improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. 
• A second patient improved from complete AIS A SCI to sensory incomplete AIS B SCI at the six-month visit. 
• Six of 11 patients (54.5 %) have had an AIS grade improvement at the six-month primary endpoint visit.

Trial Status Update: Temporary Enrollment Halt 

• The most recent patient to enroll into the INSPIRE study, who was implanted in late June 2017, passed away suddenly at a rehabilitation facility following discharge from the hospital.
  • The cause of death was deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold or implantation procedure.
  • This represents the third death in INSPIRE to date, all of which have been deemed to be unrelated to the investigational product or implantation procedure by each respective site's Principal Investigators. 
• The company has elected, based in part on discussions with the company's independent Data Safety Monitoring Board, to implement a temporary halt to enrollment as it engages with the FDA to determine whether any changes to patient enrollment criteria related to patients who may have a higher mortality risk or other study modifications are deemed necessary. 
  • As a result of the temporary enrollment halt, the company anticipates completing INSPIRE enrollment in the first half of 2018 and submitting a Humanitarian Device Exemption application in the second half of 2018.