Mirna Therapeutics halts Phase 1 clinical study of MRX34.
Mirna Therapeutics, Inc., a clinical stage biopharmaceutical company, announced its decision to close the ongoing Phase 1 study of MRX34, its investigational microRNA therapy for multiple cancers. The company voluntarily halted enrollment and dosing in the clinical study following multiple immune-related severe adverse events (SAE) observed in patients dosed with MRX34 over the course of the trial.
“Patient safety is the primary objective of our MRX34 Phase 1 clinical trial,” said President and CEO Paul Lammers, M.D., M.Sc. “We made the difficult decision to close the study after a fifth, immune-related serious adverse event was recently reported by one of our clinical sites. This patient experienced severe (Grade 4) cytokine release syndrome and is undergoing treatment. We have notified the U.S. FDA and the Korean FDA of our decision and are in the process of closing the trial.”
Mirna also announced that it will not be initiating a translational medicine study of MRX34 in melanoma patients, planned to begin later this year. The company will be further analyzing its full preclinical and clinical data set, and will discuss with its advisors, as well as the FDA, possible future development of MRX34 and will provide updates when appropriate.
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Filed Under: Drug Discovery
