A US pharmaceutical company says that with government approval, it can move to human testing on a breakthrough new therapy to cure a patient of HIV, the virus that causes AIDS.

American Gene Technologies announced it filed a 1,000-page application with the US Food and Drug Administration on its lead HIV program called AGT103-T.  The company promises this gene therapy treatment is unlike any other.  This single-dose drug is a genetically-modified product uses a patient's own cells to focus on repairing damage to the immune system caused by HIV.

"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," said the company's Chief Science Officer Dr. C. David Pauza, PhD.  "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."

If American Gene Technologies' application is approved, phase one clinical trials could begin as early as January.