RIO DE JANEIRO, BRAZIL – The US will begin human trials of gene therapy that is considered a “potential cure” for HIV next month. The FDA – Food and Drug Administration – on August 11th authorized AGT, American Gene Technologies, to initiate phase 1 human trials.
The news was disclosed by the American scientific journal Outsourcing Pharma.
“This is important news, that we have FDA approval to initiate phase I and conduct our first human trials… We are very excited… This brings us closer to our goal of changing lives through genetic medicine,” said David Pauza, Director of Science at AGT.
Genetic Therapy
The drug, called AGT103-T, is a single-dose gene therapy based on lentiviral vectors developed to eradicate HIV. It is a genetically modified cellular product made from an individual’s own cells.
AGT’s approach is unique in that it focuses on repairing the major damage to the immune system caused by HIV. The therapeutic drug should act to remove infected cells from the body and decrease or eliminate the need for lifetime antiretroviral therapy.
AGT103 is made of blood cells and takes 11 days to boost the T cells that fight HIV. It uses gene therapy to help these cells survive in the body.
According to AGT, the product is able to eliminate HIV when it comes into contact with the virus and HIV-infected human cells.
The trials
Trials should begin in September – at the Universities of Maryland, Washington, and Georgetown. The first results should be available by the end of the year.
David Pauza said that there are “high chances of the drug being effective,” given everything examined so far in studies.
The AGT103-T was designed in cooperation with government researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. According to UNAIDS, over 38 million people currently live with HIV.