Qualigen Therapeutics announces the initiation of Good Laboratory Practice, GLP, toxicology studies of its lead oncology program, QN-302, a G4-selective transcription inhibitor currently in development for the treatment of G4 expressing solid tumors, including pancreatic cancer. The study will be conducted by WuXi AppTec, a leading provider of R&D and manufacturing services that enable the pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. GLP toxicology studies are a core component of QN-302’s Investigational New Drug submission package, which is expected to occur in the first half of 2023, and will be followed by human clinical trials once the IND is cleared by the US FDA. "Among the key steps in establishing safety of QN-302 as a targeted anti-cancer therapy is to determine its preclinical toxicity profile to ensure that patients who receive the drug can safely do so. These GLP toxicity studies will generate important data as we develop our submission to the U.S. Food and Drug Administration to initiate Phase 1 clinical trials for QN-302," commented Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer.
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