Today, American Gene Technologies (AGT) announced that they will soon be beginning a Phase 1 clinical trial for AGT103-T, a potential treatment for HIV. The unique gene therapy, developed as part of AGT’s HIV program, uses patients’ own cells to address systemic damage. If you would like to learn more about AGT’s mission to potentially cure HIV, check out this video made by AGT’s Chief Scientist.

HIV

Human immunodeficiency virus (HIV) was first identified in 1981. Spread through contact with bodily fluid, usually through sexual activity or sharing drugs, HIV prevents the body from adequately fighting infection. To do this, HIV attacks cells. Eventually, without treatment, the virus can progress to acquired immunodeficiency syndrome (AIDS). There is currently no cure for HIV. However, patients can maintain a high quality of life through the use of antiretroviral therapy.

Within a few days of contracting HIV, patients may experience symptoms such as fever, night sweats, chills, a rash, sore throat, fatigue, mouth ulcers, and swollen lymph nodes. However, some patients experience no symptoms at all. If HIV progresses to AIDS, symptoms may include:

•  Rapid weight loss
• Depression
• Foggy memory or confusion
• Pneumonia
• Anal or genital sores
• Extreme fatigue
• Diarrhea
• A blotchy rash on the skin, mouth, nose, and eyelids

Learn more about HIV here.

AGT103-T

For now, the Phase 1 study will take place at various sites throughout Baltimore and Washington, D.C. Because these areas are known as hot spots, researchers believe it will place them in the best position to address this patient population. Currently, AGT plans to begin enrolling for the trial in September. Ultimately, the study aims to determine both the safety of AGT103-T and its ability to measure and identify disease biomarkers.

AGT103-T creates a genetically-modified cell product from someone’s own blood cells. First, over an 11-day period, the modification increases T-cells in the blood. When the body’s immune system is first faced with the virus, it sometimes damages and kills T-cells to the point where the immune system cannot recover.

To handle this problem, AGT103-T is specially formulated to maintain and protect these new T-cells when put back into the body. These genetically modified T-cells are able to resist infection. As a result, AGT103-T repairs the immune system, allowing people to potentially overcome their diagnosis. However, it is not yet clear whether the therapy can totally eliminate HIV cells from the body, or whether it would just decrease the need for antiretroviral therapy.

While an article in Molecular Therapy showed these promising effects when using human cell models, this Phase 1 trial will be the first to explore it in actual patients.