- InVivo Therapeutics (NASDAQ:NVIV +13%) heads north on almost double normal volume in response to its announcement of positive results in its 20-subject Phase 3 INSPIRE study assessing its Neuro-Spinal Scaffold in patients with complete (AIS A) thoracic spinal cord injuries at the time of enrollment.
- A fourth patient (out of a total of six) has converted from AIS A status (complete spinal cord injury) to AIS B status (incomplete), implying a 67% response rate. The primary endpoint of the trial is the proportion of patients who experience an improvement of at least one AIS grade by month six. The Objective Performance Criterion (OPC), a measure of success for INSPIRE, is a minimum conversion rate of 25%, significantly better than the historical rate of ~16%.
- The American Spinal Injury Association (ASIA) ranks spinal cord injury in five classes: A: Complete (no sensory or motor function); B: Sensory Incomplete (sensory but no motor function below the neurological level; C: Motor Incomplete (motor function preserved below the neurological level; D: Motor Incomplete (higher muscle function than "C"); E: Normal.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is June 2017.
- The Neuro-Spinal Scaffold is a bioresorbable polymer scaffold that is designed to treat acute spinal cord injury. It is implanted at the injury site within a spinal cord contusion where it provides structural support to spinal tissue and a supportive matrix that facilitates endogenous tissue repair. It degrades over a period of several weeks.