American Gene Technologies in Rockville, Maryland says it has submitted an application to the FDA for a gene therapy it claims eliminates HIV.
CBS Baltimore reports: “The company said the therapy, AGT103-T, is a genetically-modified product made from a person’s own cells that focuses on repairing damage to the immune system caused by HIV. The company expects to start a phase one clinical trial in humans in January.”
Said Chief Science Officer C. David Pauza, PhD: “Our aim is to treat HIV disease with an innovative cell and gene therapy that reconstitutes immunity to HIV and will control virus growth in the absence of antiretroviral drugs. Development of this complex product (AGT103-T) required our deep knowledge of both HIV disease and lentivirus vector technology; it is the first cell and gene immunotherapy addressing the most critical feature of HIV infection, which is the chronic absence of virus-specific CD4 T cells.”
Said Jeff Galvin, Founder and Chief Executive Officer of AGT: “We are excited to have reached this milestone of submitting our first IND application to the FDA for an HIV gene/cell therapy. This event brings us closer to reaching our mission to transform lives with genetic medicines. Based on our successful commercial-scale product manufacturing runs and features of the product observed in our laboratories, this therapy has a high potential to be effective. I feel confident that AGT103-T will make an important difference in the lives of HIV infected persons. HIV is the first drug candidate to result from AGT’s proprietary platform and model for creating gene and cell therapeutics more efficiently, predictably and reliably for clinical development.”