- The Washington Times - Thursday, August 13, 2020

The Food and Drug Administration has approved a phase one human clinical trial for a potential HIV cure, which will be conducted at sites in the Baltimore and D.C. area, according to a Maryland biotech company.

Rockville-based American Gene Technologies said this week it will be testing the safety of AGT103-T, a single-dose cell product made from blood cells that increases HIV-fighting T cells and uses gene therapy to help these cells survive in the body, in trial participants.

Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University will be the initial trial sites and will start enrolling patients next month.

When HIV infection kills T helper cells required for immunity, the infected person is unable to eliminate the virus and becomes chronically infected, the company said this week.

The gene therapy approach aims to fix damage to the immune system caused by HIV by repairing T helper cells and providing “durable virus control,” says a statement released Tuesday. The HIV therapeutic drug candidate could possibly remove infected cells and, thus, reduce or eliminate the need for lifelong antiretroviral treatment.



AGT founder and CEO Jeff Galvin said he is confident that AGT103-T will be an “important step towards an eventual cure for HIV.”

American Gene Technologies collaborated with researchers from the National Institute of Allergy and Infectious Diseases and says the levels of potency in the AGT103-T cell product have been validated by the government agency.

The company said it will be testing its HIV therapeutic drug in metropolitan hotspots for the immunodeficiency condition, noting that Maryland ranked fifth out of all U.S. states and territories in HIV diagnosis rates in 2018 with almost 1,000 new cases, citing state health department data.

An estimated 1.2 million people in the U.S. had HIV at the end of 2018, the most recent year data is available, according to the Centers for Disease Control and Prevention. That year, close to 38,000 people in the U.S. were newly diagnosed with HIV.

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