- Updated results from the Phase 3 INSPIRE Study assessing InVivo Therapeutics Holdings ' (NVIV -7.7%) Neuro-Spinal Scaffold in patients with complete thoracic AIS A spinal cord injury (SCI) showed a treatment benefit.
- In 16 evaluable subjects who reached their six-month primary endpoint visit, 43.8% (n=7/16) experienced an AIS grade improvement from baseline, significantly above the 25% AIS conversion rate in the literature, the Objective Performance Criterion for the study. Five of the seven patients improved from complete AIS A SCI to sensory incomplete AIS B SCI.
- As previously reported, enrollment in INSPIRE has been temporarily suspended while three deaths are thoroughly investigated. The company and investigators do not believe the fatalities are related to the Neuro-Spinal Scaffold. Nevertheless, InVivo does not anticipate reopening enrollment. It will update investors on the clinical path for the product next quarter.
- Previously: InVivo stops enrollment in INSPIRE study after third death; shares down 24% (July 31, 2017)
- Now read: Your Daily Pharma Scoop: Achaogen Is A Compelling Investment, Protalix Gains On Preliminary Results, BioTime Announces Publication Of Results
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