Exciting news! The Food and Drug Administration has given American Gene Technologies approval to begin human trials for a potential HIV cure.
According to Outsourcing-Pharma, American Gene Technologies is currently working on a drug labeled AGT103-T. AGT103-T is a single-dose, lentiviral vector-based gene therapy that could (hopefully) cure HIV by repairing immune system damage and assisting the body’s natural responses to control the virus. This is done through an 11-day process of increasing HIV-fighting T cells and boosting their rate of survival within an HIV-infected body. So far, American Gene Technologies’ research has proven encouraging and the company has published a peer-reviewed article within the Molecular Therapy journal that shows their success so far.
According to a press release, American Gene Technologies is excited to now get started on Phase Ⅰ of the first human clinical trial. They plan to conduct this study in Baltimore, Maryland and Washington, DC. More specifically, the study’s multiple locations include the Washington Health Institute, the University of Maryland, the Institute of Human Virology, and Georgetown University. The trial will begin next month in September 2020 and AGT hopes to have initial data by the end of the year.
After the FDA’s approval, AGT founder and CEO Jeff Galvin said, “I am confident AGT103-T will be an important step towards an eventual cure for HIV.”
“This is momentous news that we have FDA approval to launch Phase I and conduct our first human trials,” added Chief Science Officer David Pauza, Ph.D. “We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines. Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective.”