ProteinQure Receives Regulatory Clearance to Initiate Phase I Trial for PQ203 in the U.S. and Canada; Granted FDA Fast Track Designation
ProteinQure, a leader in computational protein drug discovery, today announced it has received regulatory clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada to initiate a Phase I clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and anti-cancer activity of its lead candidate, PQ203. The FDA has also granted PQ203 Fast Track designation for patients with triple negative breast cancer, recognizing the therapy’s potential to address a serious unmet medical need.
