NeoCart Phase 3 Clinical Trial Enrollment Update
Histogenics has now enrolled ~3/4 (183) of 245 patients required to complete enrollment of its ongoing NeoCart Phase III clinical trial, which is being conducted under a Special Protocol Assessment (SPA) with FDA.
This is an increase from 50% completion announced in mid-1Q16, after the 4Q15 amendment to the trial protocol to expand the eligible patient population.
A recent financing will fund the company through top-line data read-out in mid-2018.
The Phase III trial is designed to evaluate safety and efficacy of NeoCart tissue-engineered cartilage as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults vs. microfracture, the standard of care.
Sources: Histogenics Corporation; ORTHOWORLD Inc.