American Gene Technologies has reached a turning point in its HIV cure clinical trial: withdrawing participants from their antiretroviral drugs. This clinical protocol, technically known as “analytic treatment interruption” (ATI), represents the next logical step in the trial’s progression. Withdrawing trial participants’ antiretrovirals enables American Gene to demonstrate whether its AGT103-T gene therapy leads to a cure.
Seven patients have received AGT103-T so far. All have thus far experienced no serious adverse events, thereby demonstrating the therapy’s safety. Blood markers in the treated patients have provided a view into how the cell therapy is responding in their bodies. So far, the data has confirmed that the cells are properly engrafting, persisting, and seem to be remaining uninfected while reacting to, and likely fighting, HIV the way scientists expected.
Withdrawing trial participants’ antiretrovirals is only the first step in the months-long ATI protocol. No final determination can be made about whether the AGT103-T gene therapy worked as hoped until enough data from all seven patients is collected and carefully evaluated, which will take several months.
We recognize the excitement and anticipation generated by the trial’s progress — which is shared by everyone at American Gene — but safety and scientific rigor require us to exercise patience and exacting attention to detail as these patients experience ATI. We invite you to stay informed by signing up for our e-newsletter and following our social media channels for the very latest developments in this trial.