(WTXL) — One company is celebrating a major milestone that may lead to a potential cure for HIV-AIDS.
American Gene Technologies (AGT) announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration or AGT’s lead HIV program, AGT 103T. They submitted the 1,000 page application to the FDA Wednesday.
Officials say the single-dose cell and gene therapy is unlike any other. It's goal is to eradicate HIV in those infected once and for all.
"Our aim is to treat HIV disease with an innovative cell and gene therapy that reconstitutes immunity to HIV and will control virus growth in the absence of antiretroviral drugs" said Chief Science Officer C. David Pauza, PhD.
Around 1.1 million people in the United States are living with HIV/AIDS.
If the application is accepted by the FDA, this IND allows AGT to initiate a Phase 1 clinical trial that will investigate the safety of AGT103-T in humans and measure key biomarkers.
The company expects to begin recruiting patients for the Phase 1 study in January. However, it could be years before the drug gets final approval and can be sold on the market.