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Author Topic: HIV gene therapy trial approved by FDA - AGT103-T  (Read 3477 times)

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Offline em

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HIV gene therapy trial approved by FDA - AGT103-T
« on: November 08, 2019, 07:00:17 am »

I do not know if this has already been posted ? but it is relatively new news from nov 6
I know cure hype  believe it when you see it  thought this info might be worth sharing

https://www.localdvm.com/news/i-270/american-gene-technologies-believes-they-have-the-cure-for-hiv-aids/

Offline Mindless

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #1 on: November 08, 2019, 08:34:24 am »
Quote
AGT should hear from the FDA sometime before the end of the year. If it’s approved, they will have the green light to begin phase one of the clinical trial in January.

I guess this means that even if this is actually working (yet to be demonstrated) we’d be years maybe decades away from real world application (at what cost is another big question), is that correct?

Offline Jim Allen

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #2 on: November 08, 2019, 08:38:58 am »
https://forums.poz.com/index.php?topic=73181.msg762655#msg762655

Someone mentioned it, it's just another nice idea like so many and throwing the word cure around for investment & buzz.

Anyhow it's going into a phase 1 study, I'll find you a better link thought later today then the one you have



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Offline geobee

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #4 on: November 08, 2019, 05:22:08 pm »
I participated in something similar a while back.  A company, Sangamo, was going to use ZFN (Zinc Finger Nuclease) to edit T-Cells. The idea was to collect your T-Cells through apheresis, modify them, and put them back.  The resistant cells would survive and be immune to HIV. 

I was eventually DQ'd from the study.  Didn't have enough HIV in my blood apparently.  So they couldn't tell if it was CCR5 or not.

From what I read, this is similar.  Take your cells out, modify them to produce an AB, and put them back.  Pretty cool. 

This process is a lot less scaleable then a pill / vaccine of course.  Apheresis takes about two hours and, while not unpleasant, wasn't particularly comfortable.  Still, if this thing shows promise, sign me up! 

Offline ZachR

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #5 on: November 08, 2019, 06:14:43 pm »
It is a nice one and has made it to human trials. There is some good likelyhood for it to reach phase II and III and hope it does, but one of the potentially serious obstacles would be:
a/ no measurable effect
b/ even if it happens to work, will take at least 5 years to be available if given priority.
c/ serious immunogenicity, which could lead to a pronounced inflammatory effect throughout the body with potential consequences like organ damage and failure.
Only speculating tho, lentiviral vector technology is promising for many diseases, let's hope it grants us a safe functional cure. Even if it doesn't though, it will answer many questions that will help get closer to the real 'cure'.
« Last Edit: November 08, 2019, 06:18:58 pm by ZachR »
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline Expat1

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #6 on: November 09, 2019, 03:18:18 pm »
IF a treatment cured say 90% of people living with HIV, but killed the other 10 %, would you sign  up?

What if it cured 99% and killed only 1%?

What it the final cost/benefit level that is acceptable?  And compare that to current
practices with ART?

No answer from me?  Just a question.

(Maybe only  use with  multidrug resistant HIV after salvage therapy unable to reduce VL below a certain threshold?)

Offline ZachR

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #7 on: November 09, 2019, 04:48:02 pm »
IF a treatment cured say 90% of people living with HIV, but killed the other 10 %, would you sign  up?

What if it cured 99% and killed only 1%?
 

If it killed 10% it wouldn't be approved for widespread use anyway. In case it killed 1% while successfully curing 99, it would be approved, because numerous interventions used in medicine already have a worse risk/benefit ratio than 99/1.

Let me only remind you that we don't have a 100% guarantee that we'll make it till tomorrow, right?  So demanding 100% from those guys would be unnatural.
« Last Edit: November 09, 2019, 04:52:24 pm by ZachR »
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline Expat1

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #8 on: November 09, 2019, 09:56:57 pm »
Zack, I asked: "Would you sign up?"   Not if it would be approved.  Me no.

IF my CD4 were 25 and I was symtomatic with OIs, maybe. 

Offline em

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #9 on: November 09, 2019, 11:39:36 pm »
that was me over twenty years ago when my ID doc suggested I go on trial testing norvir.   My count was 7 viral load inconceivable large    that i gladly tried thinking even if I die at least I gave every option a try if it did not help me it might help others on the same path .    I would be willing to be selected to try this .  to help push things toward a cure .   I cannot see why anyone would not want to but that is your choice

I hope we live to see this turn out to be cure for everyone's sake 

em

Offline Expat1

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #10 on: November 10, 2019, 04:36:45 am »
Good points em. 

Whenever I see cure in the headlines with HIV , first thing I think is that it is probably a pump and dump scheme or someone wanting to make a fortune with  an IPO.   

Call me skeptical.

Offline Jim Allen

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #11 on: November 10, 2019, 05:06:34 am »
Good points em. 

Whenever I see cure in the headlines with HIV , first thing I think is that it is probably a pump and dump scheme or someone wanting to make a fortune with  an IPO.   

Call me skeptical.

I'm with you on that, every year the next big "cure" is announced and for decades nothing has panned out. If I had been a mouse, monkey or petri-dish I would have been cured a dozen times over mind you.  ;D

Scientifically it's fascinating stuff, take the "Research News & Studies" section if you like and you search for the keyword "cure" you will find decades of exciting announcements about cures some of them at human testing stages that simply did not work out. It's great we keep learning from this stuff though in the sense of scientific development

For me getting excited or hopeful every time would be an utter waste of energy & life. Worse is the odd cases of people not starting treatment or stopping as they believe there is or will be a cure soon or people taking risks because of cure headlines  😡
« Last Edit: November 10, 2019, 05:22:33 am by Jim Allen »
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Offline Almost2late

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #12 on: August 15, 2020, 07:45:11 am »
The FDA has approved a possible HIV cure gene therapy trial.

Quote
"The FDA this week authorized a Phase I trial of the product known as AGT103-T. It is made from blood cells and initiates a process that increases the body’s T cells, which fight HIV, and uses a gene therapy to help those cells survive. In preclinical studies in cell models, it has demonstrated “the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells,” according to a press release from the company, based in Rockville, Md. American Gene Technologies researched the product in collaboration with the National Institute of Allergy and Infectious Disease, a federal government agency."..

https://www.hivplusmag.com/treatment/2020/8/14/trials-begin-potential-hiv-cure?amp

Offline Jim Allen

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #13 on: August 15, 2020, 08:20:39 am »
Does not seem like everyone likes their PR spin, anyhow, as with all claims and promises time will tell.

https://www.poz.com/article/gene-therapy-cure-claims-premature-advocates-say

Quote
“From its research, AGT believes a cure is attainable and is now taking the significant step of testing in humans,” the company announced in a press release. Added AGT founder and CEO Jeff Galvin, “I am confident AGT103-T will be an important step toward an eventual cure for HIV.”

But advocates say such claims are not only premature, they are also harmful in giving people with HIV the false impression that a cure is around the corner.

AGT’s public relations strategy “preys on the emotions of people living with HIV” and “has a deleterious effect on the understanding of the cure field overall,” Seattle advocate Michael Louella told POZ. “They make their outrageous comments, and these are then picked up and believed to be certain truth. Any attempt to promote a more nuanced and better-grounded understanding of gene therapy or the clinical process becomes impossible.

“Saying ’AGT believes there is a high likelihood that participants in the upcoming trial will be cured’ is beyond outrageous and completely undermines informed consent because it’s an unethical inducement to participate [in trials],” Richard Jefferys of the Treatment Action Group told POZ.

“And it’s not based on a shred of evidence. To my knowledge, there’s no humanized mouse data, no macaque data—it’s all theory,” he continued. "I would hope that they pause to reconsider their PR strategy and broaden their consultation with stakeholders, including community-based advocates.
« Last Edit: August 15, 2020, 08:41:29 am by Jim Allen »
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Offline Almost2late

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #14 on: August 15, 2020, 09:09:45 am »
Does not seem like everyone likes there PR spin, anyhow, as with all claims and promises time will tell.

Ofcourse, time will tell, but I see nothing wrong with scientist feeling confident in there research.. I mean what are they supposed to say, "I don't think it's going to work"🤨.

It sometimes seems like these "advocates" would prefer no research into a cure at all, like they have stock Gilead or something.


Offline Jim Allen

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Re: HIV gene therapy trial approved by FDA - AGT103-T
« Reply #15 on: August 15, 2020, 11:31:42 am »
Well I don't know about what the advocates have or have not invested in, but personlly I would pefer a dose of commen sense and data to support claims about these things instead of throwing the "cure" word arround but that does not get investments, money and attention I suppose, Greed? Anyhow, I guess the hype for these things has a reason.
« Last Edit: August 15, 2020, 11:43:54 am by Jim Allen »
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