ROCKVILLE, Md. (WDVM/CNN) – American Gene Technologies believes it may have a potential cure for HIV-AIDS.
The Rockville, Maryland pharmaceutical company filed a 1,000-page application to the FDA on Wednesday.
The scientists there believe they have created a gene therapy unlike any other.
“We are doing this with a purpose with improving people’s living, relieving suffering and increasing their lifespan,” said Irene Tennant. “This is why we are here.”
Approximately 1.1 million people in the United States are living with HIV or AIDS.
Since the late 1980s, a few anti-retro-viral drugs have been able to restore the quality of life to a person living with HIV.
Yet even through that medical advancement, no treatments actually cure HIV – that’s until now.
American Gene Technologies announced the submission of an investigational new drug application to the FDA for AGT’s lead HIV program called AGT 103-T.
“Patients who are first diagnosed with HIV on treatment which contains at least three drugs at one time every day for the rest of your life,” said Tennant.
“Scientists got them that cocktail that converted HIV from a death sentence to a life sentence of taking that toxic chemotherapy,” said Jeff Galvin.
The single-dose drug has a simple purpose, to eradicate HIV once and for all, so those infected can live.
“We want to get these people out of jail and back to normal life. We see this as critically important. We need to move these people from anti-retroviral control to permanent immunity and we think this project may be able to do that,” said Galvin.
From investors to county leadership, Galvin says this has been a true community effort.
“We should all celebrate. This is something we should all take credit for in Montgomery County and in Maryland that we were able to bring all the elements together and get to this point together,” said Galvin.
AGT expects to hear from the FDA before the end of the year.
If their application is approved, phase one clinical trials could begin in January.
However, it still could be several years before the drug gets final approval and goes to market.
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