Positive data from Phase III SUMMIT trial of MACI (Genzyme/Sanofi) for cartilage repair - 14-Jul-2012

New results show that MACI (matrix-induced autologous chondrocyte implant), from Genzyme/Sanofi, met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage.

The pivotal safety and efficacy Phase III trial (SUMMIT) enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in their knees. Analysis of the clinical data showed a statistically significant improvement in the primary endpoint for those patients treated with MACI compared to microfracture. In addition, this difference met the pre-specified threshold for a clinically meaningful difference. The results from this trial will be included as part of an ongoing EMA marketing authorization application and as part of a future FDA biologics license application in the United States. The data from the study will be shared at a major scientific meeting and published in a prominent medical journal early next year.