On Wednesday, November 6th, American Gene Technologies (AGT) submitted a document almost 1,000 pages in length to the FDA that outlines what they say could have the cure for HIV/AIDS. The research facility that is based in Maryland submitted their research for Phase I trial of its autologous cell therapy for HIV reports BioBuzz.
The company has been working to develop an innovative HIV treatment that could use immunotherapy to eliminate the possibility for AIDS progression and immunity from future HIV exposures, if successful.
This new possibility is unique because it would focus on immune cells necessary for creating strong immunity against a virus and by protecting these cells to disable HIV. If successful, the cell’s natural process of building immunity can be restored and future exposure to HIV will be countered by an individual’s own immune system.
CEO of AGT, Jeff Galvin, says:
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.
AGT expects to hear back from the FDA by the end of the year or early January with information on whether they can move forward with clinical trials or not.
Why is it that news from these scientific institutions is important?
In the early days of the HIV/AIDS crisis, the BioHealth Capital Region was the epicenter of HIV/AIDS research, with much of this groundbreaking research occurring within the lab of the now famed NIH researcher, Dr. Robert Gallo. In 1983 and 1984 Gallo and his collaborators co-discovered and confirmed that the virus responsible for the killer disease known as AIDS was human T lymphotropic virus type III (HTLV-III). Gallo and the company went on to develop the first test that identified the virus in humans—the HIV-antibody blood test.
The 1995 approval of Highly Active Antiretroviral Treatment (HAART), which was the result of the remarkable, collaborative efforts of the scientific community, led to the reduction of AIDS-related deaths and hospitalizations by 60-80%. A short time later what was once a three-drug cocktail had been transformed into a pill taken once daily by HIV sufferers. – biobuzz.io
Currently there are approximately 1.1 million people living with HIV/AIDS in the U.S. and over 19.5 million people world-wide estimated to be receiving antiretroviral treatment.
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@Jeff_Taylor, we did follow it up with Pink News in the UK (and may have got ourselves a monthly treatment column out of it – we’ll wait and see). I suggest you do the same. Go for the publisher, not the journo – it’s oftnen subeditors who hype up a piece.
I’m Gus Cairns, Editor at Aidsmap.com. Pink News in the UK also picked up on this. i commented:
Oh not AGAIN.
https://www.pinknews.co.uk/2019/11/08/hiv-cure-aids-american-gene-technologies-food-drug-administration/?fbclid=IwAR02qB3LHXl-nitmz_w7bhvUm77VEZkn_ELBKjJMk4OqEcCbQntJHMlbUyc
Pink News need a hard slap for running this sort of misleading headline. I’ve had HIV for long enough to be content to die with it (not from it), but lots of people, particularly newly infected, seize on this sort of stuff desperately.
There are many promising roads that may lead to a cure (not just one) but we are nowhere near even knowing which one will get to that destination. We have cured 3 men (probably) with expensive and dangerous bone-marrow transplants you wouldn’t give to anyone unless they had cancer. One lucky woman in California developed an immune reaction to HIV that means slowly, over a period of years, she cured herself. It’s imaginable we could invent a vaccine that mimics that. We may possibly have stopped HIV infection in a few young kids by treating them very early – but not most.
What we are nowhere near is a cure that’s highly effective, works in wide variety of people, is cheap, safe, stable and scalable (the method in Pink News* falls down on at least one of these – it need pricey and specialised medical facilities.)
We will get one in the end but I’d put where we are a good 10-15 years behind an HIV vaccine – in the noughties we never thought we’d develop that, but we MAY have a partially effective one of those in the next few years.
My guesstimate for an HIV cure? This is an application for a first-line human safety trial. Even if it passes all the hurdles, this could not possibly come into the drugs market earlier than 2027-2028 at the very earliest. And only 1-3% of products tested in phase 1 trials get to market.
We may always develop a new technology that does all that stuff but on current trends, my ETA for a cure is no earlier than 2035.
Thanks, Gus. The silence from Instinct’s editors is deafening here. We should be taking this article’s author to task, as well as the editor.
David Lopez is a writer from Southern California. He writes about anything with a focus on people of color and LGBTQ+ issues. He loves film, music, travel, food, drag queens, popular culture, and libraries–but doesn’t everybody? | Follow him! Instagram: @MrDaveLopez | Twitter: @DavidLopez85
This is cutting edge technology and if you do some homework you’ll find that this company has a completely unique approach, even when compared with other gene therapy companies. It’s bound to happen and the way AGT reprograms the virus itself, Inserting it back into the patient,replicating itself, in a harmless form able to easily be destroyed by the immune system, WITHOUT harming the immune system, is the best thing we’ve seen yet.
Hopefully, they finally figure out how to make a cure that will actually work. But how much will it cost a person is the real question. Pharmaceuticals make billions of dollars of the HAART pills
Every time someone writes one of these articles that misleads the public into thinking an HIV cure is imminent, it leaves a sprawling mess for others to have to clean up. Giving people such a false believe can have real-world consequences. I do wish that publications would consider this before feeding this misinformation into the wilds of the internet.
AmenQ
belief*
I totally agree with you, Ben. How many times have we seen similar headlines over the years? And all of those other headlines were similarly hyped without having any solid foundation for the hoped for successful outcome. And what did we get instead? We got failure, failure, failure, and more failure.
Cash-strapped biotechs are always gonna be desperate to place articles like this to help them raise capital. It’s the responsibility of media to vet them and not allow themselves to get co-opted into disseminating this kind of clickbait.
Why are the editors of Instinct Magazine silent here?
That’s a very good point. Instinct missed that one. And Instinct ought to know better. You are so right. Instinct ought to pull this story.
Reacting to Morris: Shame on you. Just because someone is HIV+ doesn’t mean they will die is AIDS. Better educate yourself. And a cure does not have to be a vaccine.
I agree with you Jeff. Even if they did primate work, they need to show it actually works in HIV infected patients. It is ok to say they are working on a cure but not to say they have it until it is proven. Too many times we have been told there is a cure and then years go by and nothing more is said. It happen with research out of Barcelona Spain.
This isn’t really news. Lots of respected researchers & academic institutions have been pursuing this approach for years–with many trials already in progress. Even the most optimistic would say that even if it works, it’s at least 10 if not 20 yrs away.
Sounds like this is a private companythat is capitalizing on their Phase1 filing with FDA to issue a press release disguised as an article as a way to raise more capital. Instinct should be vetting these pharma-placed articles more closely, rather than succumbing to the clickbait trap. It’s unethical to be subjecting their readership to hype & false hope
Again a article used for advertising
Interesting
Yes. My initial thought had been that it’s just another briefing on yet another attempt to find a cure, etc, and that they’ve always let us down before, so don’t tell us now only to let us down later again… But after coming back to it I can see it as a valid attempt. If it works, though, it will require individual cures for each person. And they’d likely still show up as poz… But if it works then costs per individual cure would come down in time. It would be a cure for the rich first and then would become later a cure for all… I’m jumping ahead here though.