ROCKVILLE, Md. (WDVM) — (11/7/19) Wednesday night was an exciting one for investors and employees at American Gene Technologies. After years in the making, they submitted a nearly 1,000-page document to FDA. And within its pages just may lie the cure for HIV/AIDS.
American Gene Technologies (AGT) announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration or AGT’s lead HIV program, AGT 103T the cell and gene therapy is unlike any other.
Approximately 1.1 million people in the United States are living with HIV/AIDS.
Since the late 1980s, very few antiretroviral drugs have been able to restore a similar quality of life to a person living with the disease. Yet, even with numerous medical advancements, no treatments actually cure HIV.
The single-dose drug has a simple purpose, to eradicate HIV once and for all, so those infected can live.
“We’re doing this with a purpose,” said Irene Tennant, Vice President of Clinical Development & Regulatory Affairs. “Improving people’s lives, decreasing people’s suffering and increasing lifespan. I mean this is why we’re here.”
“We want to get these people out of jail and back to normal life,” said CEO of American Gene Technologies, Jeff Galvin. “We see this as critically important we need to move these people from anti-retroviral control to permanent immunity and we think our project may be able to do that.”
This is a big undertaking and nothing great is done in a vacuum. From investors to county leadership, Galvin says this has been a true community effort.
“This is something we should all take credit for in Montgomery County and in Maryland. We were able to bring all the elements together and get to this point together,” said Galvin.
AGT should hear from the FDA sometime before the end of the year. If it’s approved, they will have the green light to begin phase one of the clinical trial in January.