Histogenics: NeoCart Phase 3 Trial Fails To Meet Primary Endpoint - Quick Facts

(RTTNews) - Histogenics Corp. (HSGX) announced its Phase 3 clinical trial of NeoCart did not meet the primary endpoint of a statistically significant improvement in pain and function in a dual threshold responder analysis one year after treatment as compared to microfracture.

"Based on the totality of the data generated in the Phase 3 clinical trial, we continue to believe in NeoCart's potential as a treatment for knee cartilage damage. When we designed our Phase 3 clinical trial in 2009, we set a very high clinical bar for NeoCart and narrowly missed hitting the trial's primary endpoint with statistical significance by only two microfracture responders out of the 249 patients that participated in the trial. While the NeoCart treatment group exhibited a response as early as three months after treatment that continued through two years, the microfracture response rate was better than expected, which impacted the statistics. We are encouraged by the results and believe we have a meaningfully differentiated product that, if approved, can compete effectively and provide physicians and patients with a beneficial treatment option that may grow the market," said Adam Gridley, CEO of Histogenics.

Histogenics said the company is in the process of requesting a meeting with the FDA to discuss the data and a potential BLA submission.