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JustHanginginThere

AIC-316 and HSV-1 (Questions Answered and backed up with published research)

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JustHanginginThere

All-

It should be known that AIC-316 used to be called BAY 57-1293. It is widely known that AIC- 316 will work for both HSV-1 and HSV-2. When they published the Phase 2 results (even though it was completed for HSV-2) they call it a novel inhibitor of HSV-1 and 2. However, I want to draw your attention to actual studies done on BAY 57-1293 (AIC-316). Back in 2007, researchers looked at the effect of BAY 57-1293 (AIC-316) on 10 strains of HSV-1. They found two HSV-1 strains that were resistant to BAY57-1293 (AIC-316). I read every article related to this as I deal with HSV-1 and I found a very interesting note at the bottom of one of the articles explaining more about these two resistant strains:

“Variants resistant to BAY 57-1293 retained sensitivity to the nucleoside analogue, ACV.” This means that Valtrex (ACV) would work against the strains that were resistant to BAY57-1293 (AIC-316). This is very important and gives me (and should give others hope) because I personally do not respond to Valtrex—it does not reduce healing time and it does not stop an outbreak from coming. That makes me think that if Valtrex doesn’t work for me there is a high chance that AIC-316 will work. This is because it doesn’t seem (from the article) that they found HSV-1 strains resistant to both drugs.

Also many people wanted to know why AIC-316 wasn't tested on HSV-1. This is because they found these mutants. AIC-316 worked (as far as I could tell) on all HSV-2 strains so they went with the virus where they could achieve the greatest testing success. Understand this drug will change the lives of millions of people and there is NO drug out there that works for everyone. However, I believe AIC-316 is our best chance at a normal life for people like me that deal with frequent outbreaks.

If you want to learn more about all the BAY57-1293 tests just google “BAY57-1293” and learn the entire history of testing before it became AIC-316.

Full Article:

High Frequency of spontaneous helicase-primase inhibitor (Bay 57-1293) drug-resistant variants in certain laboratory isolates of HSV-1.

BiswasS, SwiftM, FieldHJ.

Source

Centre for Veterinary Science, Cambridge University Veterinary School,Cambridge, UK.

Abstract

Herpes simplex virus (HSV) helicase-primase is the target for a new group ofpotent antivirals that show great promise in vivo. A claimed advantage of thisclass of compounds is the low rate of drug resistance, which is reported tooccur at a lesser rate than acyclovir (ACV)-resistance in cell culture. Weconfirmed that BAY 57-1293 is highly active against HSV-1 and superior to ACVwhen tested in Vero cells. Notably, drug resistance was detected in laboratoryworking stocks in two different strains of HSV at 10(-4) to 10(-5) and therewas evidence that the resistant variants were present in the virus populationbefore the selection was applied. Plaque-purified clones obtained from theparental viruses showed a lower level of resistance selection in the presenceof drug (10-6) and this value is similar to published reports. In the case ofHSV-1 SC16, no difference was observed between a working stock and aplaque-pure clone in the rate of resistance to the nucleoside analogue ACV. Theworking stocks were found to contain variants with resistance to BAY 57-1293ranging from approximately 15-fold to 4,000-fold suggesting that these viruseshave the potential to subvert effective therapy. Sequence analysis of HSV-1helicase protein showed that most of the amino acid substitutions in thevariants described in this study tallied with published results, with someinteresting exceptions in the case of HSV-1 strain PDK. Resistant variants didnot readily revert to a sensitive phenotype in the absence of the inhibitor andrepresentative BAY 57-1293-resistant variants were cross-resistant to analternative helicase-primase inhibitor, BILS 22 BS. Variants resistant to BAY57-1293 retained sensitivity to the nucleoside analogue, ACV.

http://www.ncbi.nlm.nih.gov/pubmed/17354648

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britt3301

That's good to know.

Does anyone have any updates on AIC? I really think that this is the best hope we have that may have actually come out fairly soon...

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Voyager2

This drug certainly appears to be our BEST hope (until the 2 vaccines are ready). Not sure if this is the latest, but the following is from dddmag.com (4 months ago):

AiCuris' herpes-targeting compound, AIC316 has successfully completed double-blinded, placebo-controlled Phase 2 dose-ranging trials, meeting the primary and secondary study endpoints with excellent and dose-proportional efficacy and a good safety profile. It can be administered orally once daily for prophylaxis and suppression of the virus. The long halflife of AIC316 likely allows dosing only one pill per herpes episode.

AIC316 is a non-nucleosidic drug and acts via a novel mode of action targeting viral enzymes different from polymerases: AIC316 is an inhibitor of the viral helicase-primase of herpes simplex 1 and -2 virus. Based on this novel mode of action the compound offers significant benefits over existing polymerase-inhibitors:

AIC316 does not need to be activated inside the cell by a viral enzyme and thus protects uninfected cells from infection. In addition, the very long halflife of the compound allows it to protect uninfected cells over extended periods of time, in contrast to the nucleoside analogues on the market. These features result in fast onset of action and powerful suppression of viral shedding.

"Since there has been no innovation in the treatment of Herpes for years, we are extremely proud of having created this innovative drug, which is in preparation for Phase 3 and which hopefully will make a major difference for patients suffering from this viral infection. Based on its novel mode of action it will also be active against viruses which have acquired resistance against the marketed drugs", says Prof. Helga Rübsamen-Schaeff, CEO at AiCuris.

Project leader Dr. Alexander Birkmann adds: "The benefit of strongly suppressed viral shedding combined with protection of uninfected cells, may even reduce the viral burden in herpes patients treated long term or repeatedly over time and may reduce the frequency and severity of outbreaks, which is not achievable by present drugs."

Date: August 7, 2012

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Dummy
This drug certainly appears to be our BEST hope (until the 2 vaccines are ready). Not sure if this is the latest, but the following is from dddmag.com (4 months ago):

AiCuris' herpes-targeting compound, AIC316 has successfully completed double-blinded, placebo-controlled Phase 2 dose-ranging trials, meeting the primary and secondary study endpoints with excellent and dose-proportional efficacy and a good safety profile. It can be administered orally once daily for prophylaxis and suppression of the virus. The long halflife of AIC316 likely allows dosing only one pill per herpes episode.

AIC316 is a non-nucleosidic drug and acts via a novel mode of action targeting viral enzymes different from polymerases: AIC316 is an inhibitor of the viral helicase-primase of herpes simplex 1 and -2 virus. Based on this novel mode of action the compound offers significant benefits over existing polymerase-inhibitors:

AIC316 does not need to be activated inside the cell by a viral enzyme and thus protects uninfected cells from infection. In addition, the very long halflife of the compound allows it to protect uninfected cells over extended periods of time, in contrast to the nucleoside analogues on the market. These features result in fast onset of action and powerful suppression of viral shedding.

"Since there has been no innovation in the treatment of Herpes for years, we are extremely proud of having created this innovative drug, which is in preparation for Phase 3 and which hopefully will make a major difference for patients suffering from this viral infection. Based on its novel mode of action it will also be active against viruses which have acquired resistance against the marketed drugs", says Prof. Helga Rübsamen-Schaeff, CEO at AiCuris.

Project leader Dr. Alexander Birkmann adds: "The benefit of strongly suppressed viral shedding combined with protection of uninfected cells, may even reduce the viral burden in herpes patients treated long term or repeatedly over time and may reduce the frequency and severity of outbreaks, which is not achievable by present drugs."

Date: August 7, 2012

What 2 vaccines are you talking about?

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fh12

See clinicaltrials.gov , search genital herpes, and click open studies for vaccines being tested. AIC 316 is doing a Phase 2 trial now which is supposed to be completed in December 2013 to compare it against Valtrex. When will Phase 3 start? Also, is ASP2151(Astellas pharma) and AIC316 the same type of drug? Why was ASP2151 dropped? It went through a Phase 2 but no results are posted.

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Dummy
See clinicaltrials.gov , search genital herpes, and click open studies for vaccines being tested. AIC 316 is doing a Phase 2 trial now which is supposed to be completed in December 2013 to compare it against Valtrex. When will Phase 3 start? Also, is ASP2151(Astellas pharma) and AIC316 the same type of drug? Why was ASP2151 dropped? It went through a Phase 2 but no results are posted.

Well either way we have got a longgg ways to go.. but at least they are working towards it

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britt3301
Well either way we have got a longgg ways to go.. but at least they are working towards it

I don't think 5-7 years is asking too much!

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fh12

I think they started testing in 2002 on animals so I am hoping we are 3 years out at the most with this if it makes it to the market. Somebody said they could do a concurrent Phase 3 study with this Phase 2 but nothing has been released yet on a Phase 3 study.

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gbdavidx

@justhangingthere, do you have genital hsv1 or oral? Can anyone answer this, since my gf has genital hsv-1, would i catch genital hsv1 or would i get genital hsv1? if she has hsv-1 does that mean i can't get hsv2?

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lovelyoptimistic
@justhangingthere, do you have genital hsv1 or oral? Can anyone answer this, since my gf has genital hsv-1, would i catch genital hsv1 or would i get genital hsv1? if she has hsv-1 does that mean i can't get hsv2?

If your girlfriend has genital hsv1, it is possible for you to get it genitally through vaginal intercourse. You may get it orally if you have oral sex. You will not get hsv 2from from her if she onky has hsv1. Hope this answers your question. I would recommend you look at some of the threads under the transmission section of the forum :-)

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oneday

There's no way you can get hsv-2 if she only has hsv-1. It's less likely to transmit hsv from female to male..if she ever has a baby though there is a chance she could transmit to baby during delivery

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Voyager2

Dummy, the two vaccines are GEN-003 (Genocea) and HerpV (Agenus), which appear to be very promising (see other threads).

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jscl

I guess AIC316 is the most promising drug closest to the finish line. Although it still does not prevent all shedding?

I saw where they are performing another phase II trial and they upped the dose from 75 to 100mg daily dose; maybe by upping the dose it will come closer to stopping all shedding, I think this phase II will be done by October 2013.

Has anyone heard if they will start a Phase III in 2013???

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donniebrasco

Fh12,

Thank you for the brochure from aicuris. More detailed than the one that I had from last year. This drug looks very promising and our next hope. I just wish they would complete the trials already! Anyone know how to buy stock in them? :)

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fh12

You are welcome! I emailed Aicuris 12/26 asking when they will be starting a Phase 3 study. I have not heard back from them yet but from what I could find online, it may have to do with securing funding for the trial.

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jscl

AIC316 Your our BEST Hope in the near future,,, We wish you the BEST and are hopeful you will open it up to HSV1 & 2 !!!

Please start the Phase III this year (2013)!!!

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jscl

Hello everyone, I just received the below email from Aicurus. I just called the AIC316 site in TX and Apparently they still need volunteers to get this study underway. We need to get people near these sites to participate if we hope to find a better drug for us. Also, the GEN-003 needs more people to progress with their study.

Many thanks for your interest in AIC316 and our herpes program. Please find further information on our homepage (http://www.aicuris.com) and -for ongoing and planned clinical trials- under http://www.clinicaltrials.gov by entering “AIC316” in the search window.

Since AIC316 is still under development, we are unable to disclose any further information at the moment. For questions related to your inclusion in a trial or our compound AIC316, please consult your treating physician.

Thank you very much for your understanding.

Best regards,

download?mid=2%5f0%5f0%5f1%5f13617576%5fAGnTimIAAJ%2fNUPfkjgIc%2fTQNnLc&pid=2&fid=Inbox&inline=1&appid=YahooMailNeo

AiCuris GmbH & Co. KG

Friedrich-Ebert-Str.475 / Geb.302

42117 Wuppertal, Deutschland

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Dummy

Problem is.. most of them you have to be local .. There's plenty of us in the US that would do it.. just can't :-(

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fh12

Surprised the clinical trials are not in New York or California, two heavily populated states.

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Gothic Beauty

I read somewhere that they are starting phase III trials this year. Not sure how soon though.

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