Food and Drug Administration has finally given its approval to American Gene Technologies. It has started the human trials of a gene therapy which could be a possible cure for HIV.
The FDA authorized the AGT103-T, the Phase I trial of the product. It is mainly made up of blood cells and initiates the process for increasing T cells of the body and fight HIV. The gene therapy helps the cells’ survival. In pre-clinical studies, the cell models have demonstrated its ability to clear itself of HIV whenever it is challenged with HIV-infected human cells or the virus directly.
— Plus Magazine (@HIVPlusMag) August 14, 2020
The first trial phase will mainly focus on AGT103-T’s safety and measure its effectiveness. Baltimore Washington, D.C. will be the trial site for this product. The trial phase is expected to start in September.
The antiretroviral drugs only proved useful to the point that the virus becomes undetectable. However, it won’t be able to cure the virus completely. Patients from Berlin and London were reported to be in remission after getting bone marrow stem cell transplants. It is only a functional cure and very expensive and hazardous.
This treatment is not just a one time treatment, but a lifetime commitment. Recently, a man from Brazil reportedly showed no signs of the virus after receiving the antiretroviral treatment. But it is too early to declare that he has been cured. American Gene Technologies CEO and founder Jeff Galvin said,
I am confident AGT103-T will be an important step towards an eventual cure for HIV.
David Pauza, the Chief Science officer, further added,
This is momentous news that we have FDA approval to launch Phase I and conduct our first human trials. We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines.