Devices, Drug Development, FDA

InVivo Therapeutics shares tank after a third patient death in lead study

Shares of InVivo Therapeutics $NVIV tanked this morning after the Cambridge, MA-based biotech said it halted enrollment in its lead INSPIRE study after the third patient treated with its spinal cord implant died.

InVivo shares plunged more than 30%.

Investigators determined that the death was not triggered by their technology, which was developed out of lab work done by MIT’s Bob Langer and Joseph Vacanti. But after a chat with safety monitors, the biotech says it needs to hit the brakes “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.”

Mark Perrin

InVivo’s Neural-Spinal Scaffold is inserted into patients, designed to speed healing and avoid some of the lasting damage associated with complete thoracic spinal cord injury.

Factoring in the halt, InVivo now says that it expects to complete enrollment in the first half of next year and a marketing application in late 2018.

Here is CEO Mark Perrin:

Our thoughts and condolences are with the patient’s loved ones at this difficult time. We remain committed to monitoring carefully all aspects of the INSPIRE study to ensure the ongoing safety of subjects. Regarding the enrollment halt, we are working toward an expeditious resolution. Based on the compelling clinical results to date, particularly the two most recent AIS conversions, we hope to reopen enrollment as soon as possible.


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RAPS Regulatory Convergence 2017