ROCKVILLE, Md. (WDVM) — Wednesday night was an exciting one for investors and workers at American Gene Technologies. After years in the building, they filed a nearly 1,000-page file to the FDA. And inside its pages simply may lie the treatment for HIV/AIDS.
American Gene Technologies (AGT) established in Rockville, Maryland declared the entry of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration or AGT’s direct HIV program, AGT 103T the gene and cell therapy is similar to any other.
Around 1.1 million people in the USA are living with HIV/AIDS.
Since the late 1980therefore, quite few antiretroviral medications have managed to revive a comparable quality of life to a individual living with the illness. However, in spite of numerous medical improvements, zero remedies really cure HIV.
The single-dose medication has a very simple goal, to eliminate HIV once and for all, so those infected may survive.
“We are doing so with a goal,” explained Irene Tennant, Vice President of Clinical Development & Regulatory Affairs. “Improving people’s lives, diminishing people’s distress and increasing lifespan. I mean this is the reason why we’re here”
“we would like to get these folks out of prison and back into regular life,” explained CEO of American Gene Technologies, Jeff Galvin. “We view this as seriously important we will need to move these individuals from anti-retroviral management to permanent resistance and we believe our job could be in a position to accomplish this.”
That is a significant undertaking and nothing good is accomplished in a vacuumcleaner. From shareholders to county direction, Galvin says that this has been a real community effort.
“That is something we must all take credit for in Montgomery County and in Maryland. We could bring all the components together and reach the stage together,” said Galvin.
AGT must hear by the FDA sometime before the close of the year. When it’s accepted, then they will have the green light to start phase one of their clinical trial in January.