GE HealthCare announces first patient dosed in Phase 2/3 LUMINA trial

GE HealthCare (GEHC) announced the first patient has been dosed in the international, multi-center Phase 2/3 LUMINA clinical trial of its manganese-based magnetic resonance imaging contrast agent, mangaciclanol, at Mayo Clinic in Rochester, Minnesota. Mangaciclanol, if approved, could offer an alternative to – or even replace – gadolinium-based MRI contrast agents, the current standard of care. The investigational agent has been granted Fast Track designation by the U.S. Food and Drug Administration for use in adults and pediatric patients aged 2 years and older with MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and the body. FDA Fast Track designation expedites the review of new therapeutics and medical imaging agents that have the potential to address significant unmet patient needs.