American Gene Technologies (AGT), a gene and cell therapeutics company based out of Rockville, Maryland, has filed an application with the U.S. Food and Drug Administration (FDA) for a new therapy which the company claims can eliminate HIV from people infected with the disease.
The treatment, which the company calls AGT103-T, is “a single-dose, lentiviral vector-based gene therapy” that is “a genetically-modified cell product made from a person’s own cells.”
“AGT’s approach is unique in that it focuses on repairing the key immune system damage caused by HIV,” AGT said in a press release Oct. 18. “When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected.”
The release continues, “AGT’s approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells. AGT’s AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment.”
AGT entered into a Research Collaboration Agreement with the National Institute of Allergy and Infectious Diseases (NIAID) and was able to demonstrate AGT103-T’s mechanism of action.
If the application is accepted by the FDA, AGT plans to initiate a Phase 1 clinical trial that will investigate the safety of AGT103-T in humans. Patient recruitment is expected to begin in January.
Approximately 37.9 million people worldwide and 1.1 million people in the United States are currently living with HIV/AIDS.
“Since the late 1980s, antiretroviral drugs have restored quality of life to persons living with HIV and, in some cases, have even been used to prevent new infections. However, no approved treatments can cure HIV. This is an unmet medical need that AGT seeks to address,” AGT states.