American Gene Technologies (AGT) has been given US government approval to trial a gene therapy that AGT talks of as a potential cure for HIV.
The Food and Drug Administration (FDA) gave clearance for a Phase 1 trial for the research product AGT103-T starting this September in Washington and Baltimore. AGT103-T is developed from blood cells using an 11-day process that increased T-cells, which fight HIV, but uses a lentiviral vector-based gene therapy. Lentiviral vectors in gene therapy is a method by which genes can be inserted, modified, or deleted in organisms using lentivirus. Lentivirus are a family of viruses that infect by inserting DNA into their host cells’ genome. In preclinical studies, the company said AGT103-T demonstrated the ability to clear itself of HIV when challenged with the virus and HIV-infected cells.
To date AGT have made no products that are used in the ongoing treatment and management of HIV. While the trial has been cautiously welcomed, the announcement has drawn criticism for raising expectations. Derek Lowe has a PHD in organic chemistry and has worked for a number of pharmaceutical companies. In his blog he said of the trial “throwing around the word “cure”, before you have treated a single human patient, is flat-out irresponsible.” Preliminary data from the trial is expected by the end of 2020.
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