The company publicized it had turned in an application for an Investigational New Drug to the FDA for the AGT’s lead HIV program. This program, called AGT 103T, is a cell and gene therapy program unlike anything else available.
There are roughly 1.1 million people living with HIV/AIDS in the U.S.
Although HIV was discovered in the late 20th century, there are still a limited number of antiretroviral drugs that can restore a person’s quality of life. And, even though there have been significant medical advancements, there is still no cure for HIV.
The key behind a single-dose drug is to get rid of HIV altogether, allowing those infected to live once more.
AGT Clinical Development & Regulatory Affairs Vice President Irene Tennant said things were done with a purpose in mind. The goal was to improve people’s lives, reduce their suffering and boost their lifespan.
Jeff Galvin, American Gene Technologies CEO, said the key is to get people out of their medical jail and return them to life. Galvin said the move is very important – to ensure permanent immunity, which is something they feel the project can do.
It’s a huge task to undertake, and the county leadership, investors and others have helped with the effort. He said everybody involved should take credit for bringing all the elements together.
The FDA is likely to respond to the AGT report. If approved, they can start the phase one clinical trial in January.
Here’s what we've been up to recently.
An NIH Small Business Innovation Research grant to BlueWillow Biologics recently to develop an intranasal vaccine called NanoVax that could prevent chlamydia. There are over 131 million new infections of chlamydia every year with no current vaccine to help stop the infection.