The global coronavirus pandemic has taken up so much space in the news cycle that we sometimes forget that there are also other medical emergencies and advances that are being made this year. One such medical advancement that could be possibly life-changing for a lot of people is the Food and Drug Authority (FDA) giving the green light for human trials to begin on a possible cure for HIV.
A press release from the company American Gene Technologies (AGT) reveals that the FDA has approved the first phase of human clinical trials for AGT103-T, a gene therapy developed by the company that aims to eliminate HIV. It is single-dose and lentiviral vector-based.
The first phase of the human trial will involve exploring surrogate markers of efficacy, the measurement of key biomarkers, and investigating whether AGT103-T is safe to use. The trial will be at the Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University.
Before it was approved for human trials, AGT said that cell models with AGT103-T were able to “clear itself of HIV when challenged with the virus and HIV-infected human cells.”
AGT103-T is different from antiretroviral treatments as it is expected to lead to a cure for HIV. Antiretroviral treatments only control the amount of HIV one has in the body, sometime reducing it to being undetectable.
AGT CEO and founder Jeff Galvin certainly feels optimistic about the product, saying it is “an important step towards an eventual cure for HIV.”
David Pauza, Ph.D., AGT’s Chief Science Officer, echoed Galvin’s optimism, saying that their previous commercial-scale product manufacturing runs and the product’s features all point towards a “high potential to be effective.”
“We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines,” he said.