STRONG DATA FROM DISAPPOINTING NEOCART TRIAL (Orthopedics This Week)
So close, they were … Histogenics Corporation, that is. When it comes to biologics, you want high standards—and that is where the Waltham, Massachusetts company started.
Recently, they announced that their Phase 3 clinical trial of NeoCart—a restorative cell therapy—did not meet the primary endpoint of a statistically significant improvement in pain and function in a study one year after treatment as compared to microfracture.
But the silver lining is in the details, says the company.
President and CEO Adam Gridley told OTW, “This is the largest and first prospectively designed, randomized clinical trial in North America evaluating the safety and efficacy of a restorative cell therapy to treat knee cartilage damage.”
“Ten years ago, we set an extremely high bar for success with a dual threshold responder analysis (and this was before FDA guidance). On top of that, we chose what was at the time the highest meaningful clinical difference threshold. Our scientists designed an elegant endpoint, but at the time they didn’t appreciate the robust nature of what it took to hit those endpoints.”
“Not only is cartilage the ...
