July 31, 2017
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – Shares of InVivo Therapeutics (NVIV) have plunged more than 28 percent in premarket trading this morning after the company announced it was temporarily halting its experimental spinal cord implant trial due to a patient death.
In a statement this morning, Massachusetts-based InVivo said the most recent patient who enrolled in the Inspire study “passed away suddenly” while at a rehabilitation facility following the surgical implant. In June, the patient underwent surgery that implanted the company’s experimental Neuro-Spinal Scaffold. The biodegradable device is surgically implanted in patients who are dealing with a complete thoracic AIS A spinal cord injury. The patient participated in the Inspire trial, which is aiming to demonstrate improvement in ASIA Impairment Scale (AIS) grade from baseline at the six-month visit following the procedure.
InVivo was in the process of enrolling patients into the Inspire trial, but the halt will delay enrollment completion until the first half of 2018, the company said this morning.
InVivo announced the temporary halt to the trial, but noted that the patients’ death was determined to be unrelated to the implant. This marks the third death in the Inspire trial, but InVivo said all three of the deaths have been determined to be unrelated to the spinal implant or the surgical procedure used to install the device.
While the deaths may have been determined to be unrelated, InVivo said acting on the advice of the independent data monitoring committee, it was temporarily halting the trial. While the trial is temporarily halted, InVivo said it will meet with the U.S. Food and Drug Administration (FDA) discuss whether or not there needs to be any enrollment changes to the trial. The company said it will focus the discussion on patients who may have a higher mortality risk or other study modifications are deemed necessary.
Mark Perrin, InVivo’s chief executive officer and board chairman, said the company remains committed to monitoring all aspects of the Inspire study to ensure the ongoing safety of the patients. He said the company was working toward an “expeditious resolution” to the temporary halt of the Inspire trial.
While the company expressed its sorrow at the most recent death, InVivo pointed to some positives from the Neuro-Spinal Scaffold implant. The company said six of 11 patients (54.5 percent) have had an AIS grade improvement at the six-month primary endpoint visit.
Dr. Travis Dumont, director of the neurovascular program at Banner University Medical Center Tucson in Tucson, AZ and principal investigator in the Inspire trial, said the results were encouraging. In a statement, he noted that one patient he performed the implant procedure on converted from AIS A to AIS B within the six-month period. On the impairment scale, a patient with an A rating has no sensory or motor function in the sacral segments S4-S5. A patient on the B scale has sensory but not motor function, and it’s preserved below the neurological level and includes the sacral segments S4-S5.
Shares of InVivo fell to $1.76 in premarket trading, but have fared better since the market opened this morning. InVivo is trading at $2.15 per share as of 9:33 a.m.
