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    • Cas9
      @Ohsotired It took 10 years for mouse studies? Not sure if that's true, but anyway, it takes a while when starting out because you're kind of starting from scratch. That also involves in vitro work. Then you need to go to mice. So the in vitro and mice work is where a lot of the figuring out has taken place. It involved a lot of painstaking work. In fact Dr. Jerome started with an old style editor (CRISPR hadn't been invented yet). When he wasn't getting the results with whatever editor he was using, and CRISPR was invented, he then switched to CRISPR. He got worse results with that. His team then figured out what the issues were, step by step. And finally we are where we are; i.e. 90% and 50% cleavage in SCG and TG. And he knows what the issue is regarding improving those percentages to 90%+ in the DRG and TG. So a lot of the figuring out took a while and now we just need to see that it works in guinea pigs and then primates. Unless something goes wrong, and there's no reason to believe that it will, we are not going to take 10 years for each animal of course. If things go smoothly I would say 3 or 4 years. Then on to clinical. But we'll see. " Most researchers spend 3-6 years in the preclinical stage of research, 3-7 years in the clinical phase, and 2-5 years afterwards to launch the drug for public use. That’s Titans about 18 years in all for a drug to make it to mainstream. " So you chose the high end for each range. If I choose the low end for each it's 8 years. It's really impossible to predict. But I think the majority of us think that if it's successful it's at least 10 years away. Before your research, how long did you think the process would take? If it takes 10 years, how old will you be?
    • hk81
      The funding from NIH for the lab tests on mice will end in 2023, so this can give an idea on the timeline. https://grantome.com/grant/NIH/R01-AI132599-01A1 When the tests are moved to bigger animals (guinea pig and monkey), the possibility of experimentation is lower due to higher costs. The tests on monkeys are done only when the research has reached some solid results and only a few combinations are tested (see for example the tests done by ExcisionBio on monkeys for their CRISPR therapy for HIV). So I don't expect that (if everything works as expected) there will be bigger delays at that point. Usually when the funding from NIH ends, the research should have managed to run extensive tests on animals to gather further funding (often private) to move toward clinical trials. This period is called "the valley of death"; if there is not enough evidence that the therapy is effective, it will be more difficult to gather the attention of private investors and the research will run on lower funds and it will slow down or it will be stopped. Also: since it is a therapeutic application, the clinical trials might be faster than a prophylactic vaccine, unless side effects arise. There is no need to check that the therapy is protective on the long time, waiting for the participants to expose themselves to a pathogen (I also would not expect that they will check the condition of a participant for too long, because he might have exposed himself to another strain of herpes or the same one, if immunity will decrease after the therapy).  Hopefully once the first successful clinical trial, they will be able to get a fast-track and early-access as it happened with pritelivir.
    • asdfz
      Any CRISPR updates for HSV?
    • Ohsotired
      I don’t know why, but I decided to research the drug/medicine implementation process this morning. In my quest of knowledge, I found some disheartening information. Most researchers spend 3-6 years in the preclinical stage of research, 3-7 years in the clinical phase, and 2-5 years afterwards to launch the drug for public use. That’s Titans about 18 years in all for a drug to make it to mainstream.  Dr. Jerome has been working for nearly 10 years & has not finished the preliminary preclinical data. He’s only completed work with mice: no guinea pigs or monkeys. The reality set in that there’s so much more time needed. Hopefully, he doesn’t take nearly 10 more years to complete the next studies.    Afterwards, he’ll need to conduct a Phase I trial on humans, followed by a Phase IIa trial, proof of concept trial, Phase IIb trial,   Phase III trial, & regulatory review.  I was cautiously optimistic, but I’m starting to become cynical. This could take upwards to 20 years.   
    • Just a human being
      Try google T cells gut flora encephalitis. Can try to find it if u can’t.  I know Wilso could crack it but it common knowledge and educated on in groups by well respected HSV advocates from organisations that the virus can travel via other nerve routes. Whether this has any baring or truth in your case at all no idea. 
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lali

Pritelivir

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lali

Does anyone have any updates on pritevilir's results? I can't find anything on the net. Is it still doing good? Last thing i saw was when it got fasttracked.

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MikeHerp

The trial is ongoing.  I believe it will be completed around september or octrober of this year.

Things are on track as far as I know.

 

EDIT:

https://clinicaltrials.gov/ct2/show/NCT03073967

Estimated Primary Completion Date : August 2019
Estimated Study Completion Date :

October 2019

 

This means, it is estimated that all data for all aspects of the trial, will be collected by Oct 2019 (all data related to the primary end point will be collected by August).  I'm not sure exactly by when the report would be published--perhaps a few months later? 

 

Edited by MikeHerp

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MikeHerp

By the way, I continue to have high hopes for this.  Unlkess something goes wrong, I think it might have a decent chance to get approved.

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Miss Horne
14 hours ago, MikeHerp said:

By the way, I continue to have high hopes for this.  Unlkess something goes wrong, I think it might have a decent chance to get approved.

I hope so, if this fails then I’m afraid I’ll be ingesting yellow jasmine (If you watch Outlander you’ll know what I’m on about). 

If you haven’t seen it then watch it, it’s about two hot people having loads of amazing sex in Scotland 200 years ago ;)

Apologies, I’ve gone slightly off subject here! 

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oneday

Would love for the damn dna to be shut down for good. Don't care if it stays there, just want to the bloody pest of a disease shut down. 

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Skrillah80
3 minutes ago, Hopefloats30 said:

Is it just something like a suppressant?

Yeahh pretty much.. Functional cure hopefully we get it in a couple years from now

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Hopefloats30
40 minutes ago, Skrillah80 said:

Yeahh pretty much.. Functional cure hopefully we get it in a couple years from now

Uggh a couple of years ...

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Skrillah80
1 minute ago, Hopefloats30 said:

Uggh a couple of years ...

Who knows.. It might be right around the corner.. 

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Miss Horne

We are waiting patiently for the data results to be published later on this year, about October time. 

If these are good we are hoping it doesn’t need to go to a phase 3 category and that it will be prescribed to immunocompromised patients, this could take another good couple of months. Depending on which county you live in, you could potentially get your hands on the drug then.

If it’s good to go on immuncompromised patients then perhaps trials can start on healthy folks, this is when we need to get together as a group and start making some noise with a petition. 

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123445
5 hours ago, Skrillah80 said:

Who knows.. It might be right around the corner.. 

Say everything goes accordingly does this mean it could be used for genital hsv1?

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Miss Horne
49 minutes ago, 123445 said:

Say everything goes accordingly does this mean it could be used for genital hsv1?

Yes, it will be a treatment for both strains, regardless of site of infection :)

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MikeHerp

Josh Bloom stated a few months ago that he thought pritelivir may be approved within 2 years.  He did note that he's going out on a limb with that prediction.

But it seems reasonable.  Earlier results suggested it's twice as effective as valtrex.  The only question is safety.  

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Skrillah80
41 minutes ago, MikeHerp said:

Josh Bloom stated a few months ago that he thought pritelivir may be approved within 2 years.  He did note that he's going out on a limb with that prediction.

But it seems reasonable.  Earlier results suggested it's twice as effective as valtrex.  The only question is safety.  

Soo when you thinking they gonna have this functional cure for the USA? 

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MikeHerp
1 hour ago, Skrillah80 said:

Soo when you thinking they gonna have this functional cure for the USA? 

It's being tested in the USA.  Because it's fast tracked, it could be approved based on the phase 2 results without needing phase 3.

Data will be collected by Oct this year.  I'm guessing it may take a few months to analyze and publish the results, so maybe end of this year or so.

Then, if those results show safety and efficacy (the main issue would probably be safety), then they submit an application for approval.  I'm not sure how long that takes, but maybe another 6-12 months?  

So yeah, altogether a bit less than 2 years.

But, it would be approved for immunocompromised.  Others would have to try to get it off label (I believe it may be possible).

And it wouldn't exactly be a functional cure.  Even with pritelivir, there was still shedding and outbreaks, though rarely.  Maybe combined with valtrex for some people it might approach a cure like effect (at least while you are taking it).  

Still, I'm guessing it would be a significant difference maker for many people.  

Edited by MikeHerp

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lali
On 2/3/2019 at 6:18 PM, MikeHerp said:

Josh Bloom stated a few months ago that he thought pritelivir may be approved within 2 years.  He did note that he's going out on a limb with that prediction.

But it seems reasonable.  Earlier results suggested it's twice as effective as valtrex.  The only question is safety.  

I was just about to say this. But since i didn't see anything new on the trial i was curious if anybody would of seen or hear anything. Not sure if it can go straight to the market without phase 3. I just hope they find a way to reduce the toxicity and it becomes available soon. The results just sounds so much better than valacyclovir. I'll take anything i can get to reduce transmission. 

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MikeHerp
3 hours ago, lali said:

I was just about to say this. But since i didn't see anything new on the trial i was curious if anybody would of seen or hear anything. Not sure if it can go straight to the market without phase 3. I just hope they find a way to reduce the toxicity and it becomes available soon. The results just sounds so much better than valacyclovir. I'll take anything i can get to reduce transmission. 

My understanding is that a drug CAN go to approval based on phase 2, if it has been fast tracked.  I've looked this up and I understand it is correct.  Pritelivir has been fast tracked.  That's why I believe Bloom claimed it could be approved within 2 years.

I think it could help, but keep in mind that it's only being tested in immunocompromised people.  Still, I think if it is approved, "healthy" people will be able to get their hands on it sooner or later.  I really believe that.  It will be out in the market.

 

 

 

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Miss Horne

Toxicity issues were reported but that was because they gave the poor individuals 70 times the recommended dose.

If you gave anybody 70 times the recommend dose of anything, paracetamol, ibuprofen, viagra etc whatever they’d suffer toxicity issues. 

Imagine the trials for viagra though, 70 times the recommend dose and a load of men with rock hard dicks for days on end! 

Edited by Miss Horne

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Miss Horne
3 hours ago, MikeHerp said:

I'd be interested in taking 70 doses of viagra.  

lol

I’d be interested in meeting up with you if you took 70 doses of viagra @MikeHerp ;)

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Miss Horne

Come to think of it, I think it was chimps they gave 70 doses to. 

Imagine that, a lab full of horny chimps for days, now my job doesn’t seem so bad! 

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JHenry
1 hour ago, Miss Horne said:

Only 30 participants? That seems low? 

 

The Indianapolis trial is dated Mid-November, 2018

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