American Gene Technologies has received Food and Drug Administration approval to begin human trials of a gene therapy being touted as a possible cure for HIV.
The FDA this week authorized a Phase I trial of the product known as AGT103-T. It is made from blood cells and initiates a process that increases the body’s T cells, which fight HIV, and uses a gene therapy to help those cells survive. In preclinical studies in cell models, it has demonstrated “the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells,” according to a press release from the company, based in Rockville, Md. American Gene Technologies researched the product in collaboration with the National Institute of Allergy and Infectious Disease, a federal government agency.
The Phase I trial will investigate the safety of AGT103-T and measure some factors that indicate whether it’s effective. The company will conduct the trial at sites in Baltimore-Washington, D.C., metropolitan area, which has a large number of HIV cases. It is expected to begin in September.
While antiretroviral drugs can control HIV to the point that it’s undetectable, they are not a cure for the virus. Two patients, one in London and one in Berlin, have been reported to be in remission from HIV after receiving bone marrow stem cell transplants, something scientists call a “functional cure” but not an outright one, and the transplants are too hazardous and expensive to be used widely.
Antiretroviral treatment is a lifetime commitment, and the drugs can have side effects or become ineffective at some point. At this year’s International AIDS Conference, doctors reported that a man with HIV in São Paulo, Brazil, shows no signs of the virus even after going off antiretrovirals and without receiving a transplant, but they said it’s too early to declare him cured. So the search for a cure continues with products like AGT103-T.
Executives of American Gene Technologies expressed optimism about the new therapy. “I am confident AGT103-T will be an important step towards an eventual cure for HIV,” founder and CEO Jeff Galvin said in the press release.
“This is momentous news that we have FDA approval to launch Phase I and conduct our first human trials,” added Chief Science Officer David Pauza, Ph.D. “We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines. Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective.”