ROCKVILLE, Md. (WDVM/CNN) - American Gene Technologies believes it may have a potential cure for HIV/AIDS.
The pharmaceutical company announced the submission of a 1,000-page Investigational New Drug Application to the FDA for their lead HIV program, called AGT 103-t.
Approximately 1.1 million people in the U.S. are living with HIV or AIDS.
Since the late 1980s, antiretroviral drugs have helped restore quality of life to those living with HIV.
Despite this medical advancement, no treatments cure HIV.
The AGT scientists said they believe they created a gene therapy that will eradicate HIV in the form of a single-dose drug.
“We see this as critically important,” CEO Jeff Galvin said. "We need to move these people from antiretroviral control to permanent immunity and we think this project may be able to do that.”
AGT expects to hear from the FDA before the end of the year.
If their application is approved, Phase I clinical trials could begin in January. It could take several years before the drug receives final approval and goes to market.