Phase II clinical trial of HIV vaccine is go after success of Phase I - Polidicks

[URL="http://mediarelations.uwo.ca/2016/12/01/western-virologist-hopes-test-vaccine-600-hiv-negative-subjects-next-fall/"]http://mediarelations.uwo.ca/2016/12/01/western-virologist-hopes-test-vaccine-600-hiv-negative-subjects-next-fall/[/URL] [QUOTE]An HIV vaccine (SAV001) developed at Western University can now move on to Phase II human clinical trials. Plans are underway to test it in 600 HIV-negative subjects across North America as early as next fall. The Phase II trial, once approved by government regulatory agencies, will determine the vaccine’s ability to produce anti-HIV antibodies in patients who are not infected with the virus. The results of the Phase I trial were published this week in the journal, Retrovirology, and showed that the vaccine is both safe for use and effective in triggering an anti-HIV immune response in HIV-positive patients. The results demonstrated that the vaccine was well tolerated with no serious adverse events and can now proceed to Phase II.[/QUOTE] Nice to have some uplifting news time to time.

Science!!

Imagine curing HIV. That'd be fucking unreal.

[QUOTE=Doctor Zedacon;51461504]Imagine curing HIV. That'd be fucking unreal.[/QUOTE] yeah and you'd probably end up needing to pay 10 grand for it at the rate things are going with pharmaceuticals in the U.S.

As long as Martin Shkreli doesn't get in his hands.

[QUOTE=DETrooper;51461615]yeah and you'd probably end up needing to pay 10 grand for it at the rate things are going with pharmaceuticals in the U.S.[/QUOTE] I dunno, after learning about the London Declaration, I feel like there might just be hope for people to afford it w/o much debt. If the demand is great enough, big pharma would be shooting themselves in the foot to charge it so stupidly high. (But then again that didn't stop EpiPens from going up that high).

I'm hopeful this one will pan out. It saddens me that the issue was ever politicized. We could have made so much more progress if we seriously funded research, and actually listened to our health organizations when it came to prevention. We had a significant group of dissent even within the scientific community. For a while a number of prominent scientists rejected the notion that HIV causes AIDS, and some politicians used that as justification to not do anything at all. The recession back in 2007 shut down funding for a potential vaccine under trial in South Africa as well.

[QUOTE=LoneWolf_Recon;51461721]I dunno, after learning about the London Declaration, I feel like there might just be hope for people to afford it w/o much debt. If the demand is great enough, big pharma would be shooting themselves in the foot to charge it so stupidly high. (But then again that didn't stop EpiPens from going up that high).[/QUOTE] Why the hell are there hundreds of london declarations? [URL="http://apps.who.int/iris/bitstream/10665/60718/1/WHO_GPA_INF_88.6.pdf"]It took me 5 minutes to find the right one.[/URL]

[QUOTE=jordguitar;51461860]Why the hell are there hundreds of london declarations? [URL="http://apps.who.int/iris/bitstream/10665/60718/1/WHO_GPA_INF_88.6.pdf"]It took me 5 minutes to find the right one.[/URL][/QUOTE] Whoops, [URL="https://www.youtube.com/watch?v=qNWWrDBRBqk"]forgot to link it[/URL].

[QUOTE=LoneWolf_Recon;51461721]I dunno, after learning about the London Declaration, I feel like there might just be hope for people to afford it w/o much debt. If the demand is great enough, big pharma would be shooting themselves in the foot to charge it so stupidly high. (But then again that didn't stop EpiPens from going up that high).[/QUOTE] The London Declaration unfortunately only applies to NTDs. Sure, NTDs and HIV/AIDs had a huge overlap (and still might I imagine) in tropical areas of the world, but HIV is not a "neglected" tropical disease, along with malaria and tuberculosis. Those get much great greater attention. That's not to say that if this treatment/cure were made available, that charities, governments, and maybe even pharmaceutical companies wouldn't provide it to the impoverished at low or no cost. They very well could. That would be the ideal outcome, and thankfully I think it's likely given that profiting off of HIV/AIDs is not something Pharma would look good from.

I'll celebrate if it manages to pass Phase II. I can't remember the statistic, but only a ridiculously low percentage of drugs ever pass it.

[QUOTE='Poesidan [GAG];51461966']The London Declaration unfortunately only applies to NTDs. Sure, NTDs and HIV/AIDs had a huge overlap (and still might I imagine) in tropical areas of the world, but HIV is not a "neglected" tropical disease, along with malaria and tuberculosis. Those get much great greater attention. That's not to say that if this treatment/cure were made available, that charities, governments, and maybe even pharmaceutical companies wouldn't provide it to the impoverished at low or no cost. They very well could. That would be the ideal outcome, and thankfully I think it's likely given that profiting off of HIV/AIDs is not something Pharma would look good from.[/QUOTE] Check my post. The WHO has a London Declaration for HIV.

[QUOTE=FlandersNed;51462207]I'll celebrate if it manages to pass Phase II. I can't remember the statistic, but only a ridiculously low percentage of drugs ever pass it.[/QUOTE] of about 10000 chemicals (which are usually program generated variations of existing molecules) 10 will have a clinical trial and of those 1 will make it to the market. something like that

And to think of all of the idiots who fear vaccines and gluten more than they do of dying of HIV and nuclear desolation

Is this what people meant by never hearing about it again?

This is actually pretty major

[QUOTE=FlandersNed;51462207]I'll celebrate if it manages to pass Phase II. I can't remember the statistic, but only a ridiculously low percentage of drugs ever pass it.[/QUOTE] Around 30% pass Phase II, 50% for Phase III + regulatory approval on average. I'm not sure about vaccines but I have a feeling that they have better odds compared to oncology or heaven forbid, Alzheimer's. [editline]5th December 2016[/editline] [QUOTE=uitham;51462629]of about 10000 chemicals (which are usually program generated variations of existing molecules) 10 will have a clinical trial [/quote] That's not true. Despite what you may have heard, new drugs don't come from hitting randomise on existing drug scaffolds. And if you include all the compounds made for all projects, then the number will be way higher than 1000-to-1. [quote]and of those 1 will make it to the market. something like that[/QUOTE] This is mostly true.

[QUOTE=Slender|Man|;51461666]As long as Martin Shkreli doesn't get in his hands.[/QUOTE] Oh for fuck's sake He gave it away for [i]free [/i]to patients who couldn't afford it. You realize that, right?

[QUOTE=gk99;51481619]Oh for fuck's sake He gave it away for [i]free [/i]to patients who couldn't afford it. You realize that, right?[/QUOTE] He got demonized for all the wrong reasons to be frank- He did what he did to shiv it to the Insurance Companies that made their members pay high premiums for this medication and those who couldn't afford it he gave it to them for free. The price increase was to prove a point to the Insurance companies and what the Pharmaceutical companies could do.

[QUOTE=Derpmonster;51481682]He got demonized for all the wrong reasons to be frank- He did what he did to shiv it to the Insurance Companies that made their members pay high premiums for this medication and those who couldn't afford it he gave it to them for free. The price increase was to prove a point to the Insurance companies and what the Pharmaceutical companies could do.[/QUOTE] [QUOTE=gk99;51481619]Oh for fuck's sake He gave it away for [I]free [/I]to patients who couldn't afford it. You realize that, right?[/QUOTE] It's funny that this propaganda actually worked on people

[QUOTE=Aztec;51481700]It's funny that this propaganda actually worked on people[/QUOTE] Don't understand what you mean here- You're saying the propaganda against him or for him? Because either way, it was clear that there was heavily falsified propaganda against him.

[QUOTE=FlandersNed;51462207]I'll celebrate if it manages to pass Phase II. I can't remember the statistic, but only a ridiculously low percentage of drugs ever pass it.[/QUOTE] That's because before phase II there's only like maybe 50 people max that have taken the drug and Phase I testing is primarily just to find dosage amounts. Stage II and III are where the real testing actually begins in terms of human testing because you're looking at at least 100 people in stage II and at least 1000 in stage III. In the world of medical testing, phase II/III is when we find out that the simulations/maths and very limited tests didn't account for some random genetic defect combined with them having X new strain of the common cold, etc, so it actually causes 5% of men's penises to fall off and 10% of women grow penises and then of that 10%, 5% have them fall off. Or other stupid shit like that. Most drugs that make it to clinical testing are actually an even smaller percentage because they also passed years of animal and simulation tests, which many drugs don't. Basically it's when we discover weird interactions with humans that we couldn't figure out with simulations, rats and an incredibly small sample size of about 50 people or so. Source: I've researched medical testing to death because I'm primarily an investor in medical research companies.

[QUOTE=Derpmonster;51481794]Don't understand what you mean here- You're saying the propaganda against him or for him? Because either way, it was clear that there was heavily falsified propaganda against him.[/QUOTE] Shkreli didn't "just" want to make a point, he wanted his company (and himself) to make a bunch of money. Insurance companies will just move the costs onto its customers like everything else, so good on Shkreli, he's such a great guy. Sure, giving it to free for people who can't afford it and need it to live is "great", but all this acting like he's doing nothing nefarious at all is absurd.

[QUOTE=Slender|Man|;51461666]As long as Martin Shkreli doesn't get in his hands.[/QUOTE] You know he gives 60% of his drug away for free right? His company is losing money. The reason he raised the cost of the drug so high is so that he could take money from the insurance companies in order to fund RND for a better drug. Daraprim is over 70 years old and only treats some 4,000 or so people in the US who have toxoplasmosis. His drug has little to do with AIDS other than the fact that it weakens the immune system and allows taxoplasmosis to be a problem. The reason he needs to develop a new drug is because the old one is now essentially useless against malaria, and is starting to become ineffective in treating toxoplasmosis. It's also good at destroying an enzyme in your brain that is also present in the disease. So he's not as big of an asshole as he's made out to be.

How would you even run phase III trials of a drug like this? Prick their finger and see if they get aids? How does testing this kind of stuff work once it leaves petri-dish testing?

Curing HIV seemed like only a dream years ago, and now we've made some really incredible progress on our way there. We still got ways to go but this is enough to get my hopes up. Fucking incredible.