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Medicine Biotech

Company Seeks FDA Approval For Single-Dose Drug To Cure HIV/AIDS (nbc4i.com) 92

Posted by EditorDavid from the gene-therapies dept.
"Wednesday night was an exciting one for investors and employees at American Gene Technologies," reports a local Maryland news station. "After years in the making, they submitted a nearly 1,000-page document to FDA. And within its pages just may lie the cure for HIV/AIDS."

Founded in 2007, the privately-held company has less than 50 employees according to LinkedIn. Based in Maryland, the company's milestone was soon picked up by other local newscasts, including one attributed to WDVM/CNN.

Long-time Slashdot reader Aristos Mazer writes: This is not one of those on-going maintenance drugs. This, they claim in 1000+ pages of FDA filing, is an out-right cure. The drug, AGT 103T, delivers a virus that performs cell and gene therapy.

In AGT's words: "Gene therapy is a technique that allows doctors to treat a disorder by inserting genes into patients' cells to mitigate the underlying genetic drivers of disease. Human cells can be re-engineered to create highly-effective hunter/killers of invasive pathogens or cancer cells, or reprogramed to produce secretions that provide potent remedies to other disease conditions."

If FDA approves, then AGT will have the green light to begin phase one clinical trials in January 2020.
"Our aim is to treat HIV disease with an innovative cell and gene therapy that reconstitutes immunity to HIV and will control virus growth in the absence of antiretroviral drugs," the company's chief science officer told CBS Baltimore.
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Company Seeks FDA Approval For Single-Dose Drug To Cure HIV/AIDS More

Company Seeks FDA Approval For Single-Dose Drug To Cure HIV/AIDS

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  • If the FDA reject it, they should take their tech to other countries to trial. There is a big industry treating HIV
    • It does sound very interesting. However, if they are using a virus to alter a patients DNA how do they stop this virus spreading to other people and altering their DNA as well?
      • 'They started a world wide fast zombie infestation which wiped out the human race in a matter of weeks. But at least they cured HIV." You mean like that?

        • Re: Zombies - patient zero (Score:4, Funny)

          by apoc.famine ( 621563 ) <apoc.famine@noSpAM.gmail.com> on Sunday November 10, 2019 @06:05PM (#59400860) Journal

          'They started a world wide fast zombie infestation which wiped out the human race in a matter of weeks. But at least they cured HIV." You mean like that?

          You know what they say, "Don't let the perfect be the enemy of the good."

          • i am so happy because Dr Tokubo has healed me from HIV ailment which i have been suffering from the past 5 yearsnow, i have spend a lot when getting drugs from the hospital to keep me healthy, i have tried all means in life to become HIV negative one day, but there was no answer until i found Dr Tokubo the great herbalist of African who provide me some healing herbal medicine which he sent to me through courier to my address in USA , now i am glad telling everyone that i am now HIV Negative, i am very happy

      • It does sound very interesting.

        I'm betting this "single dose" is going to be very, very expensive.

        • I'm betting this single dose doesn't work. I can't see how, from the description given, something like this is supposed to work outside of a science fiction movie. In which it almost immediately goes rogue and produces a plague of zombies.

          I doubt we'll hear much more about this once the media hype dies down.

          • Re: (Score:2)

            by ceoyoyo ( 59147 )

            I don't think making it work is the problem. It's fairly easy to create a virus that will splice a gene into a cell. T-cells are created all the time.

            The problem is likely getting it to stop.

          • A "single dose" is often enough to infect you with any other virus, so that part seems fairly normal. Creating genetically engineered viruses sounds futuristic (it's only been 47 years since the first one!) but this is how gene therapy works and using it to treat HIV isn't a new idea. This is just the first company to potentially start human trials. We won't know the efficacy until after the trials, but it's not obvious why this would be uniquely riskier than any other GT treatment.

            The GP guessed right that

          • Such a thorough and technical rebuttal is refreshing to see here on /. !!

        • Yep. I would guess at least $100,000 USD per dose in the first year, but maybe closer to a million. Hopefully the price will come down over time as more and more rich people get cured. I bet the investors were promised a starting price of a million per dose.

        • You're saying that no product should be made unless it's first offering is cheap?

      • Presumably, they'd use a virus that has a very limited lifespan.

        That said, they're probably using a retrovirus much like HIV, but less lethal/more limited. One of its functions, which believe it or not, OTHER diseases have been known to do, is to disable HIV infected cells.

        So I'd say that they'd prevent infection spread by having them practice safe sex and safe needle use for the infectious period, because it'd have a similar infection profile to HIV, IE STD and intravenous drug use.

        That said, anybody mana

        • Lifespan is mostly not a relevant concept to viruses - which have no metabolic processes, and die in the act of infecting a cell.

          You'd have to reliably keep the virus from successfully replicating once it infects a host cell in order to keep it from spreading - and doing that would likely make producing enough virii to do any good an extremely expensive proposition.

    • Re: (Score:2)

      by cb88 ( 1410145 )
      The question is not so much can it prevent HIV/AIDS but can it do so .. in a manger that is safe to put into the gene pool... many of these gene modification methods butcher the DNA to get what they want. For it to be completely safe it needs "surgical precision"

  • If just one shot is needed then they will need to charge a lot of $$ to pay for all the R & D and to get a decent profit. But if just one shot is needed then most people (or insurance) will be happy to pay a lot to avoid having to take many doses of other drugs.

    I hope that the existence of this does not mean that people will stop taking other precautions when having sex.

    • If just one shot is needed then they will need to charge a lot of $$ to pay for all the R & D and to get a decent profit.

      Don’t worry, they’ve already set up a Patreon page.

    • All gene therapies are heinously expensive right now, in the hundreds of thousands of dollars. Maybe if something like this pans out, there will be an actual industry mass-producing the treatment and that will lower the costs.

    • Yeah, I second your hope that people don't stop taking other precautions when having sex. Other STDs have become incurable again too, or are incurable to begin with.

      Antibiotics no longer work on some cases of gonorrhea and chlamydia, I'm not sure about syphilis. I hear that herpes isn't fun either, and the viruses that cause genital warts can also lead to cancer.

  • Casual sex, condom use, etc. We may not go back all the way to "free love" of the 60s/70s, but there'll be a change. In the developing world, where 36 million infected live, where 1 in 25 in subsaharan Africa have it, it may change a lot more than sex practices. And if HIV/AIDS is beaten, other diseases which seem unbeatable may also be defeated by the use of this new kind of medical technology.

    • I don't know about that. There are still plenty of STDs to go around, and many of them actually have worse symptoms than HIV (certainly when HIV is dormant and does not become full blown AIDs, which can be decades if taking the existing medications that are quite effective).

    • The same Africans who won't take aids anti virals won't take this. For reasons....
    • Casual sex without condoms and you end up like this guy [nypost.com]. Quote:

      nearly half of his paycheck is garnished for his offspring. “I don’t know what’s more surprising: that five sued or that 17 didn’t,” Nagel says.

    • Has already changed in the gay community.

      PrEP is a highly effective way to prevent infection with HIV. It it quite hard on your liver however and so patients using it must have a 90 day checkup with their doctor to get a new prescription, where blood tests are done to check liver function, as well as a full STD screen.

      Obviously not everyone is using PrEP nor can access it, but a very large number of people can.

      I've seen some references to the fact that STD rates in general have declined thanks to PrEP, beca

    • And if HIV/AIDS is beaten, other diseases which seem unbeatable may also be defeated by the use of this new kind of medical technology.

      Once they developed the very successful treatment to cure Hepatitis-C, I figured this would happen sooner rather than later. It's not the same approach, but once the retro-viruses start to fall, I think they'll all fall.

      Even the "sticky" genotypes of HCV can now be cured easily (if not cheaply).

      By the way, if you're between 30 and 60, you should definitely be tested for HC

      • Re: (Score:2)

        by muridae ( 966931 )

        There was only one sticky genotype of HCV, Genotype 1. Labeled 1 because it was the primary genotype discovered in white Americans when doctors and labs started separating HCV apart from the generic category of "non-A, non-B viral hepatitis". Genotypes 2-4 actually responded really well to Interferon treatments, I recall G4 having around a 50% cure rate after just 3 months back in the late 90s or early 2000s, when even simple antivirals weren't around to augment it. But G1, whether the TC or CT variant, had

    • Casual sex, condom use, etc. We may not go back all the way to "free love" of the 60s/70s, but there'll be a change.

      This would be the biggest nightmare scenario for today's academic harpies. Nobody would read their articles on Slate any more.

    • There's no material cure for despair.

  • Did I just read that this thing can cure cancer?

    • Nothing cures cancer. It can only go into remission. Cancer is the effect. The cause must be found and fixed/removed or cancer will come back.
      • [citation needed]

      • You've got that a little backwards - *everyone* has cells becoming cancerous all the time, but normally your immune system kills such rogue cells quite effectively.

        Occasionally though one of the mutant rogue cells will be "camouflaged" as a healthy cell and be able to multiply in peace - at which point you must resort to other methods to eliminate the entire population of cells. Leave even one single cell behind, and you're right back where you started. And tumors aren't structurally sound growths - it's

        • Uhm, no. I'm not even sure where to start. Your description is generally correct but in no way is mine backwards. There are a small number of people with cancer who are cancer free 10+ years later but this is not the expectation for most cancers. And to ChrisMaple above who wants a citation... seriously? Type "cancer" into Google. I did and then read every article on all the major sites intended for public and a few for medical professionals. I'm not your "type google for me!" guy, sheesh.

          • So, you googled cancer, and now you're an expert that we should defer to? Is that what you just said?

            • If someone can't even bother to type cancer into google and only posts "citation" then yes. If they're going to waste my time asking me for links they could have easily found themself then they get the standard reply: go to google. Why are you so easily triggered? I'm sorry someone in your family has cancer. Try this: go to google and type "cancer". It's a good start.

          • >There are a small number of people with cancer who are cancer free 10+ years later but this is not the expectation for most cancers.

            Of course not - what part of the implication of "it will grow back if you leave even one single cancer cell alive" and "cancer cells break off of tumors and lodge themselves elsewhere in the body" isn't clear? Combine that with the fact that cancerous cells can look just like non-cancerous cells during surgery, and that none of the technologies that improve visibility are

      • The cause of most cancers is known â" it is mutation caused by viral or environmental factors. You cannot eliminate cancer, but it can be cured. Our cells mutate all the time because they are constantly bombarded with ionizing radiation and free radicals. Usually the mutation is corrected or not a big deal. If the mutation is bad, most of the time the cell commits suicide. If that doesnâ(TM)t happen, the immune system destroys the cancer cell. Only a mutant cell that got lucky enough to escape th

        • Uhm, yeah. We're saying the same thing. I'll try again: cancer is caused by other stuff. Stuff is either genetic or other illness or external events, like radiation poisoning, for example. If caused by something internally it will come back. If caused by external events unless every single cancer cell is killed -and- no other cells are flipped due to the external event (good luck on that), then it will come back. So again, cancer is not cured for almost anyone. It only goes into long term remission at

  • Can't wait.. (Score:5, Insightful)

    by RightSaidFred99 ( 874576 ) on Sunday November 10, 2019 @04:46PM (#59400620)
    I can't wait for the breathless media pieces and twitter mobs demonizing this company when people see the price tag.

    • In fifteen years, the price tag will drop to near nothing. Already, Gilead's pricing model is collapsing. Greed will also form copycats.

      But then, the same techniques might also be rife for abuse, misuse, and creations of uber-humans. Imagine: no chance of malaria, cancer, HIV, HSV1/2, hepatitis anything, c.diff, cystic fibrosis, cholera, etc etc.

      Only of course, if you can pay for it.

      • Re:Can't wait.. (Score:5, Insightful)

        by apoc.famine ( 621563 ) <apoc.famine@noSpAM.gmail.com> on Sunday November 10, 2019 @06:45PM (#59400952) Journal

        In fifteen years, the price tag will drop to near nothing.

        And if not, the price will drop to a plane ticket to China plus a few bucks.

        Seriously, if it's a one-time, one shot cure, you just fly to any country in the world that doesn't respect that US patent and get your shot, then come home. I bet at least a few European countries will go that way. If you've got socialized health care, it's crazy not to. The monetary benefit would be tremendous.

        A whole lot of the things you mention cost orders of magnitudes more to deal with over a lifetime than a plane ticket. Or a bus ride to Canada. Or a cruise that stops in Havana.

        • Maybe a trip to Mumbai isn't so bad....

        • Seriously, if it's a one-time, one shot cure, you just fly to any country in the world that doesn't respect that US patent and get your shot, then come home. I bet at least a few European countries will go that way.

          Well, no. If you do that you'll have the WTO up your ass in a heartbeat.

        • >And if not, the price will drop to a plane ticket to China plus a few bucks.

          I worked out that this is also true for getting a nice custom suit made. However I'll wait for my next business trip there and save myself the personal airfare.

        • I guess it is better than dying of AIDS but I'd be hard pressed to go to China for gene therapy... I'd shoot for the EU or so as to not end up finding out what the lots of the treatment that should've been rejected by QC did.

      • Remember that most countries have some form of universal health coverage. In addition, infectious diseases is one of those areas where it's better to not catch the disease at all, even if you can purchase a cure for it. The cure may not work on you, for example, or have bad side effects.

        So it actually makes sense for smart rich people(I know, many are NOT smart) to pay to have all the lower wealth people cured, because that provides protection for them. Sure, it is a relatively expensive way to do it, bu

        • This is unlikely to happen. Worse, I fear for its potential abuse. Despite that fear, I'm hoping it works in trials.

      • Call me cynical but, in 15 years even if all goes well it will still not have made it to market, or if so, barely. They haven't even begun Phase I (safety) trials let alone Phase II (efficacy), or Phase III (large population safety/efficacy). All of which combined take years.
    • That's not what will happen. Big pharma will sue AGT out of existence, based on some alleged patent infringement, then they'll bury its technology. It doesn't fit the long tail revenue model that Big Pharma has created to treat symptoms with regular dosages rather than cure diseases.

  • Be hopeful, but don't hold your breath (Score:4)

    by unfortunateson ( 527551 ) on Sunday November 10, 2019 @05:01PM (#59400662) Journal

    The number of drugs that make it from Phase I Clinical studies to market is a percent or two. Safety issues that don't show up in petri dish or animal experiments can easily derail such products.
    And this is a novel drug, it will get a lot of scrutiny... But it's a major advance, it will get prompt, likely fast-track review.

    • And this is a novel drug, it will get a lot of scrutiny... But it's a major advance, it will get prompt, likely fast-track review.

      A bunch of desperate rich folks who have HIV/AIDS are probably inquiring how to get this drug now on the black market.

      Even without any review or further tests.

      • Re:Be hopeful, but don't hold your breath (Score:5, Insightful)

        by Lanthanide ( 4982283 ) on Sunday November 10, 2019 @06:29PM (#59400916)

        Doubtful, because HIV is no longer a death sentence and hasn't really been since the late 90s. Life expectancy of someone with HIV is very close to that of someone of the same demographics without it. Since the 90s the side-effects of the drugs have gotten much better and aren't much of a big deal now.

        Rich people can obviously afford these drugs. No reason to risk their lives or potentially suffer serious complications from an untested drug like this.

        • Truth

        • However, it's still a hit to their ego and a hit to their ability to get sexual partners on a whim.

          Those are still powerful motivators to people with more money than sense.

          • Re: (Score:2, Insightful)

            by 0111 1110 ( 518466 )

            Unless you are female and young and superhot I think you can forget about any sexual partners for the rest of your life. Unless you are willing to lie about your HIV+ status which is a crime in some countries. You may even have trouble keeping friends once they found out. Best thing would be to pal up with a non-human animal like a dog or parrot because no human will ever want to be with you again. That part of your life is over when you get HIV.

    • Re:Be hopeful, but don't hold your breath (Score:4, Informative)

      by Kjella ( 173770 ) on Sunday November 10, 2019 @09:33PM (#59401384) Homepage

      The number of drugs that make it from Phase I Clinical studies to market is a percent or two.

      No, that's from initial research, also sometimes confusingly called phase one. Most ideas die on the drawing board or in lab/animal testing. If you've reached clinical trials it's about 1 in 10, but that's just an average spread across many types of medications from incremental improvements to niche treatments for rare conditions and any radically new class of drug probably has much lower probability than that.

      • Re: (Score:3)

        by ceoyoyo ( 59147 )

        Phase I to market is about 20%. But that includes a lot of drug tweaks, iterations, and other stuff that's pretty much guaranteed to succeed. The success rates of new class drugs, and particularly "drugs" that are actually viruses doing in vivo genetic therapy, are a lot lower.

  • Phase 1 (Score:5, Insightful)

    by phantomfive ( 622387 ) on Sunday November 10, 2019 @05:10PM (#59400690) Journal

    If FDA approves, then AGT will have the green light to begin phase one clinical trials in January 2020.

    It's phase 1, that means they are still trying to determine whether it will kill people or not. Not really worth getting your hopes up.

  • tempered expectations, but the right thing to do (Score:4, Interesting)

    by Goldsmith ( 561202 ) on Sunday November 10, 2019 @05:57PM (#59400830)

    As many people have pointed out, this is a phase 1 trial, meaning that it's (statistically) very unlikely to pan out right away.

    For the last few decades, it's become obvious that large pharma companies are unable to pursue drugs like this effectively. The scientific, regulatory, and ethical risks here are very high. The company pursuing this is a "pharma startup", a company financially designed to take these risks. They've been working on this commercially for 12 years (after earlier academic work). Even so, the cost for them to do this is much less than what a large company would have paid.

    These kinds of high-risk high-reward projects are necessary and much more common in tech than in pharma. It's easy to see why. It took them 12 years to get far enough to file their application to start clinical trials (they're almost as old as Facebook). Good for these guys for getting this far and shooting for a real world improving success.

  • Until a drug like this gets to Phase 3 it's simply not newsworthy. Phase 1 is where so many drugs get cut since it's usually a very low dose first wave human trial.

    The headline makes it sound like they're about to file which is very misleading.

    • Phase 1 trials for HIV or cancer *cures*, especially ones involving novel new technology, are newsworthy.

      But not in a "this is about to cure the disease" sort of angle that this is being slanted with.

    • For what it's worth, here's the supposed stats for experimental drugs:
      • 70% pass Phase I
      • 33% pass Phase I and II
      • of which 70% - 90% pass Phase III

      After which, FDA market approval can be requested. (source) [centerwatch.com]

  • Now He needs to come up with a new way to punish gays.
  • A better term would be biological agent since it's actually a genetically engineered virus. From what I know most drugs have fairly low fixed costs. However anybody know how expensive it is to make a custom engineered virus?(If it's hard to make don't expect the usual government edict of it should be cheap to work.) The only one I know of is Zolgensma and that's expensive as hell. (I'm guess it's probably tough to make this virus but I have no real idea.)

  • I am skeptical about the one shot part. But even if the cells persist a year or two in my opinion thats a win. The other thing I am skeptical about is whether it (alone) can cause the CD4 T-cell count to increase in patients whose CD4 cells have depleted.

  • Do the inventors, the inventors and others at this company (or any other, that will deliver the cure) deserve billions of dollars in financial rewards?

    Or are we going to demand, they make it affordable, stopping profiteering on the backs of the innocent sufferers, and sell it at the same price, at which one can get it in Botswana?

  • This corporate take-30-years-to-develop-jack-shit model could be about to break in the worst way possible for these giant pharma companies. If someone uses CRISIPR (queue the gasps and squeals of the public and the MSM) in their basement to cure HIV [sciencealert.com] then all this FDA/Corporation/Asshat handwaving by governments and greedy suits won't be worth a damn thing. Now, I'm sure plenty of people will say "I would never do that" and that's fine. Others will say "Oh, that's so dangerous!" and that's totally fucking f
  • i am so happy because Dr Tokubo has healed me from HIV ailment which i have been suffering from the past 5 yearsnow, i have spend a lot when getting drugs from the hospital to keep me healthy, i have tried all means in life to become HIV negative one day, but there was no answer until i found Dr Tokubo the great herbalist of African who provide me some healing herbal medicine which he sent to me through courier to my address in USA , now i am glad telling everyone that i am now HIV Negative, i am very happy

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