Histogenics plunges on missed endpoint in NeoCart trial

Histogenics (NSDQ:HSGX) said today that a pivotal trial of its regenerative NeoCart knee treatment failed to meet its primary endpoint, sending its share price down some -70%. Waltham, Mass.-based Histogenics said NeoCart, which is designed to repair knee cartilage damage using cells harvested from the surface of patients’ femur, missed the study’s primary endpoint of statistically significant improvement in pain and function at one year compared with microfracture. The prospective, randomized study used the Knee Injury & Osteoarthritis Outcomes Score and the International Knee Documentation Committee  score for the main endpoint of at least a 12-point improvement in the KOOS pain sub-score assessment and a 20-point improvement in the IKDC subjective assessment. In the intention-to-treat analysis, 121 of 170 patients in the NeoCart arm, or 71.2%, showed a positive response, compared with 49 of 79 or 62.0% of the control arm. The news sent HSGX shares down -72.2% to 77¢ apiece today in early trading. “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 NeoCar...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Orthopedics Regenerative Medicine Wall Street Beat Histogenics Source Type: news