ARTICLE | Clinical News

MRX34: Phase I discontinued

September 26, 2016 7:00 AM UTC

Mirna voluntarily terminated an open-label, dose-escalation, dose-expansion, U.S. and Korean Phase I trial of IV MRX34 after a fifth, immune-related serious adverse event was reported in patients who received the compound. The company said the patient experienced respiratory failure requiring ventilator support and suffered a seizure, which subsided with sedation. The patient remains in critical condition. Mirna plans to analyze preclinical and clinical data and discuss with FDA on the possible development of MRX34. The trial was evaluating MRX34 for 5 consecutive days in the first week of each 21-day cycle for 3 cycles and planned to enroll about 200 patients. ...