The Office of Clinical Trials of Health Canada has issued its “No Objection Letter” to two clinical trial protocols developed by Xemed and its Canadian collaborators, clearing the way for a new international branch of its research investigations into clinical indications for its hyperpolarized 129Xe magnetic resonance imaging agent MagniXene™. Earlier in the summer, Xemed had submitted a “Drug Master File” on MagniXene™ to Health Canada to begin the two-step regulatory filing process.
The hyperpolarized gas human imaging team at University of Western Ontario, led by Dr. Grace Parraga of Robarts Research Institute.