TAMPA, Fla. - A gene and cell therapy company says they may have a potential cure for HIV and AIDS.
American Gene Technologies announced the submission of an Investigational New Drug Application to the Food and Drug Administration for their lead HIV program, called AGT 103-T.
The 1,000-page submission details AGT's single-dose cell and gene therapy, which aims to eradicate HIV.
"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 the company's Chief Science Officer C. David Pauza, PhD.
The company says about 1.1 million people in the US live with HIV/AIDS.
Since the 1980s, antiretroviral drugs have helped improve the quality of life of those living with the infection. However, there are no treatments that can cure HIV.
AGT said they expect to hear from the FDA before the end of the year.
If the application is approved, phase one clinical trials could begin as soon as January. However, it would likely take several years before the drug could get final approval and go to market.