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Why was AIC316/pritelivir clinical trial for herpes treatment terminated??


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Hi guys,

 

I'd like to get your input on this because I'm honestly puzzled. Recently a clinical phase II trial was terminated studying the efficiency of a new viral inhibitor, AIC316 (also known as pritelivir, developed by Aicuris) against Valtrex http://clinicaltrials.gov/show/NCT01658826. There was quite a bit of promising talk about this new drug which was shown to be safe in the phase I trial. It targets a new mechanism of viral replication and was expected to be much more efficient than Valtrex. There's even a petition to congress to fast track this drug http://www.petition2congress.com/4807/fda-fast-track-aic-316-hsv2-therapeutic-drug/.

So why on friggin earth was the trial stopped? I read rumors on safety concerns (even though it passed phase I, weird...), but I could not find any official press release, explanation by Aicuris http://www.aicuris.com/, and there is no info on the clinical trial site!? Not even a word on whether just this particular trial was terminated or whether the development of this drug was stopped altogether. Has anybody heard anything? Thanks!!

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Hey Angel!

 

Hmmm, that is strange. Everywhere I've looked it doesn't mention any current updates to the trial. It looked like it was quite promising. And hey, for the many years I've been running this forum, many, many supposed herpes cures/treatments have come around and died due to stringent testing requirements. It's the nature of the beast.

 

The latest press release I found for this specific clinical trial was back in January:

http://www.aicuris.com/index.php/fuseaction/download/lrn_file/2013-01-29_pr_50percent-recruitment-aic316-press-release.pdf

 

And just a reminder to all of you holding out on a cure, we don't have to wait for a cure to start living our lives now! Plenty of people have moved on from the shame of herpes into self-acceptance without a cure. Here's a blog article I wrote on just that:

http://herpeslife.com/herpes-cure/

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Yeah, Aicuris is definitely lagging behind in their response to the termination of the trial... I'm curious if they continue trials in non-FDA regulated countries...

And yes, I am living my life now, but it would still be nice to have a drug available that reduces the chances of infecting somebody else even more than Valtrex does. There literally hasn't been any new innovation since Valtrex, which was released decades ago!

 

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  • 4 weeks later...

Nice! So if the study doesn't have any hiccups, there should be a vaccine by 2020. :) And in the meantime, let's still shoot for getting to the point where a vaccine coming to market doesn't need to happen for the stigma to leave and for us to live and love fully. We still have work to do on ourselves. A vaccine won't save us from that. And still great that they are working toward it.

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The trial was suspended by fda for possible toxicity issues; aicuris terminated the trial to unblind the study. Everyone involved with the study was supprised by the fda's actions since the trial required to be on the medication for four weeks. The fda pointed to animal studies that involved 20 times the doses involved in the study. Aicuris is trying to resolve their real or imaginary concerns.

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