Qualigen announces U.S. FDA IND clearance to initiate Phase 1 trial of QN-302

Qualigen Therapeutics announces that the U.S. Food and Drug Administration has cleared the Company’s IND application for QN-302, a potential best-in-class small molecule G-Quadruplex-selective transcription inhibitor. Based on this clearance, the Company plans to initiate the Phase 1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors. Michael Poirier, Qualigen’s Chairman and CEO, commented, “This is a pivotal milestone for our therapeutics pipeline as it transitions us into a clinical-stage company. The IND clearance for QN-302 brings us closer to our objective of developing best in class treatments that can potentially provide new therapeutic options for patients with advanced or metastatic solid tumors. Our clinical team has worked diligently to prepare for this milestone and is now dedicated to start enrolling patients, anticipated to take place in the second half of 2023.”