US – American Gene Technologies (AGT) has been cleared by the Data and Safety Monitoring Board (DSMB) under a unanimous vote to continue with its HIV cure program after safety analysis of the participant’s data revealed no adverse effects from the treatment.
AGT’s HIV cure program is based on a platform that has the capacity to treat other chronic viral infections, as well as monogenic disorders and cancers.
The nod by DBSM gives AGT the confidence to keep pushing for the cure against HIV/AIDS cure.
“Safety represents a critical milestone in the project and gives us additional confidence that HIV can be cured,” said Jeff Galvin, CEO. “This milestone supports AGT’s mission to relieve suffering and premature death from serious human diseases. AGT’s HIV cure program is based on a platform that has the capacity to treat other chronic viral infections, as well as monogenic disorders and cancers. Our ImmunoTox program has yielded pre-clinical data showing the potential for revolutionizing solid tumor cancer treatment, and our Phenylketonuria gene therapy may be a one-and-done cure for patients suffering from that inherited disease. A success in HIV would provide sustained funding to accelerate dozens of therapeutics that are within the scope of AGT’s technology platform.”
Today, approximately 37.9 million people worldwide, including 1.2 million people in the United States, are living with HIV/AIDS.
The U.S. government has estimated that 38,900 Americans were newly infected with HIV and 1.7 million individuals globally were newly infected with HIV in 2018.
Since the late 1980s, antiretroviral drugs have prevented AIDS, HIV transmission, and mortality in persons living with HIV and, in some cases, have been used prophylactically to prevent new infections.
However, no approved treatments can cure HIV and AGT is committed to addressing this unmet medical need.
AGT’s Phase 1 RePAIR (Restore Potent Antiviral Immune Responses) trial for AGT103-T is currently underway at trial sites in the Maryland / Washington, DC area.
RePAIR trial is the company’s first step in clinical testing of cell and gene therapies for HIV, cancer, and rare diseases.
The drug, AGT103-T is a genetically modified cell product made from a person’s own cells. AGT’s approach is unique in that it focuses on repairing the key immune system damage caused by HIV.
When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected.
AGT’s approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells.
AGT’s AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment.