Express Pharma

American Gene Technologies gets US FDA nod for Phase 1 clinical trial of potential HIV cure

AGT’s Phase 1 trial will investigate the safety of AGT103-T, a single-dose, lentiviral vector-based gene therapy, and measure key biomarkers as well as explore surrogate markers of efficacy

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American Gene Technologies (AGT) announced approval by the FDA (Food and Drug Administration) to begin Phase 1, the first human clinical trial for AGT’s HIV program. AGT will conduct its Phase 1 study at clinical sites in the Baltimore/D.C. area and has named Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University as its initial trial sites. These sites are expected to begin enrollment in September 2020.  AGT hopes to report initial data before the end of the year.

AGT’s Phase 1 trial will investigate the safety of AGT103-T, measure key biomarkers and explore surrogate markers of efficacy. AGT103-T is a single-dose, lentiviral vector-based gene therapy developed to eliminate