The company claims the gene therapy drug can wipe out HIV in one dose.

American Gene Technologies in Rockville, Maryland, has submitted an application for a new HIV drug to the U.S. Food and Drug Administration. The drug, called AGT103-T, is combined with a patient's cells and works to repair their T helper cells. The repaired T cells then fight off the HIV virus, potentially curing the patient forever. The technology may be used in the future to cure other diseases including cancer.

Once the application is accepted by the FDA, American Gene Technologies can begin a Phase One clinical trial. The company hopes to open the clinical trial to patients in January. Currently, people with HIV take antiretroviral drugs to keep the infection under control. AGT103-T, if successful, would be an immunotherapy drug that would cure HIV in a single dose.

"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 Chief Science Officer 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.”

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The Rockville company already has seven patents for an immuno-oncology process that uses gamma-delta T cells to kill solid tumors and a synthetic gene that treats Phenylketonuria or PKU. What was once a death sentence is now manageable with drug treatment.

It is estimated that more than one million people in the U.S. are living with HIV or AIDS compared to nearly 38 million worldwide. This drug would be a breakthrough for patients with HIV and act as a ladder to curing other serious diseases.