Josh Milton, PinkNews, Nov 8, 2019
Yesterday, the American Gene Technologies (AGT) submitted their study for Phase I retail of its autologous cell therapy for HIV, reported BioBuzz.
The therapy involves an individual's cells - cultured and expanded outside the body - being then reintroduced back into the donor.
Researchers, based in Maryland, said their aim with the study is to break those living with HIV "out of jail and back to normal life".
If successful, researchers said, the body's natural immunity to HIV can be restored. As a result, people's immune systems will counter the disease like any other.
In a statement, AGT CEO Jeff Galvin said: "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 our project may be able to do that."
Scientists submitted the proposed plan, called an international new drug application, to the Food and Drug Administration - the federal body that deals with public health.
They can expect to hear back from the FDA by the end of the year or early January to confirm whether the project can move forward with clinical trials or not.
According to its application, AGT aim to recruit patients in the early new year.
Around 37.9 million people across the world are living with HIV, according to statistics, while nearly 20 million have access and are taking antiretroviral treatment.
However, as much as acquisition rates of HIV continue to plunge in certain patches of the world, access to the necessary treatments continues to be snarled by governments and pharmaceutical companies.
In the US, the makers of PrEP - a crucial preventative pill - Gilead Sciences empties the pockets of those needing it, activists warn, as a year's supply can cost an American around $20,000 a year.
While researchers are in tireless pursuit of a cure to the disease, activists have warned that more needs to be done to slash treatment prices and increase education around the disease.
Moreover, some HIV experts have stressed that the research project is still in its "early days".
UK-based activist Matthew Hodson told PinkNews: "Although any advance in the quest for a HIV cure is to be welcomed, I would urge people not to get overly excited by this project at this stage.
"This research is still seeking approval for a Phase One trial so it is very early days.
"Phase One trials ensure that the treatment doesn't cause harm. In Phase Two, they start to test the theory and Phase Three is when they gather evidence as to whether a particular approach is effective, so there are many hurdles yet to cross.
"We've seen promising cure approaches fail in recent years.
"Even if all results are optimal, we would not expect anything to come to market for about another seven years.
"What we need is a cure that's highly effective, works for a wide variety of people, is cheap, safe, stable and scalable.
"We do not know yet whether the approach outlined here will meet any of those criteria but it looks as though it will require pricey and specialised medical facilities."
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