AiCuris announces completion of AIC316 Phase II genital herpes trial

[mamaem]

AiCuris announces completion of AIC316 Phase II genital herpes trial

8. December 2010 06:14

– AiCuris announced today that the last subject has completed their Phase-II trial "A double-blind randomized placebo controlled dose-finding trial to investigate different doses of a new antiviral drug in subjects with genital HSV Type 2 infection".

The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol. "We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus" said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. "In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes".

AiCuris plans to have the first data available in early 2011. "We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action", adds Prof. Rübsamen-Schaeff, CEO of AiCuris

[mamaem]

Oops, saw just then that it had been posted in a different thread. But I'll leave it in this section as well if anyone (like me...) misses the other section!!

[dinki]

THANK YOU SWEET JESUS! ONCE THIS GOES INTO PHASE THREE TRIALS AND IS SUCCESSFUL WE WOULD BE CURED!!!! Thanks mamem for posting this! i almost am in tears! its funny how they said "We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus" are you kidding me? i would sign up for anything that remotely has a chance against this fucked up virus! This is great news fellow herpsters lets keep this research trial in our prayers. Hopefully this also forces other researchers working on a cure to hasten up!

[struggle83]

This looks like more suppression not a cure, or am I wrong?

"AIC316 belongs to a new class of anti-

HSV compounds, the helicase-primase inhibitors, which have a mode of action that is distinct

from that of nucleoside analogues currently in clinical use (e.g. acyclovir). "

[dinki]

This looks like more suppression not a cure, or am I wrong?

"AIC316 belongs to a new class of anti-

HSV compounds, the helicase-primase inhibitors, which have a mode of action that is distinct

from that of nucleoside analogues currently in clinical use (e.g. acyclovir). "

AWWW! i got too excited too soon ure right! its another fucking drug for suppression! now im crying for real!

[dinki]

Read this struggle http://elsevier.conference-services.net/resources/247/2020/pdf/ANTI2010_0071.pdf maybe it'll make more sense to you. i saw the words completely suppress and got excited

[struggle83]

Read this struggle http://elsevier.conference-services.net/resources/247/2020/pdf/ANTI2010_0071.pdf maybe it'll make more sense to you. i saw the words completely suppress and got excited

Hmmm. I don't know how that relates to a life-long human hsv latent infection. Typically inhibition/suppression has to do with the DNA sequencing when the virus is replicating. Does anyone know more details?

Maybe it something that we can get annual injections for. Wouldn't that be amazing? I still think a subcutaneous implant would work well.

[pangle161]

Well, I guess the more they work towards the suppression and getting the virus dealt with faster. The closer were getting to a cure.

[helpiamconfused2]

If AICURIS is complete suppression along with complete stoppage of shedding, this is probably as good as we're going to get for several years - up to a decade.

I know many people are against taking suppressants daily, but I don't see it being a lot different from taking a baby aspirin to prevent heart attacks...

This appears to be a huge positive... Now with that said, the FDA will let this drug go to market while they do phase III testing. They have a policy in place to permit this is a treatment is "superior" to existing treatments. So, we may need to line up and approach both the FDA and AICURIS to make this happen...

Thoughts?

[struggle83]

If AICURIS is complete suppression along with complete stoppage of shedding, this is probably as good as we're going to get for several years - up to a decade.

I know many people are against taking suppressants daily, but I don't see it being a lot different from taking a baby aspirin to prevent heart attacks...

This appears to be a huge positive... Now with that said, the FDA will let this drug go to market while they do phase III testing. They have a policy in place to permit this is a treatment is "superior" to existing treatments. So, we may need to line up and approach both the FDA and AICURIS to make this happen...

Thoughts?

My thoughts relate to another post in the Technical forum and that's what I am curious about this therapy. If this inhibits the virus does it mean no more pains and itching or can a suppressed virus still do this?

I don't get blister and such because I have GHSV1 but I get constant pains and itches.

[Sweet7]

AIC-316 is supposed to stop all outbreaks and shedding. It is also supposed to reduce the viral load. It my be another suppressant, but if taken correctly, it would be like not having herpes. As good as a cure until one is available. But, we won't know for sure until the phase II results are in. I agree with help. I hope that Aicurius will apply for fast track status since this drug would be superior to any other drugs currently available. We have to put pressure on the FDA if they do. From what I read, I think it's a real possibility. It is also my hope that this will get other pharma's moving on it as well.

[struggle83]

AIC-316 is supposed to stop all outbreaks and shedding. It is also supposed to reduce the viral load. It my be another suppressant, but if taken correctly, it would be like not having herpes. As good as a cure until one is available. But, we won't know for sure until the phase II results are in. I agree with help. I hope that Aicurius will apply for fast track status since this drug would be superior to any other drugs currently available. We have to put pressure on the FDA if they do. From what I read, I think it's a real possibility. It is also my hope that this will get other pharma's moving on it as well.

What about testing it on HSV1? I hope it is similarly effective.

From what I have read about AIC316 the Phase 2 trial was to test dosing. So it sounds like this is going to be an effective treatment.

[Sweet7]

Struggle, I'm pretty sure I read somewhere that Aicuris believes that this drug will work on HSV-1 as well. They may include testing during the Phase III trial. They are not saying anything at this time. The cool thing is that they are affiliated with Bayer and they it appears they are pushing this drug ahead of the others and trying to beat other pharma's to the market. I just sent them this email:

On behalf of the millions of sufferers of HSV, I want to say thank you to the scientist and staff who have worked so hard to bring this drug about. I hope that Aicuris will try to obtain a fast track status with the US FDA if possible. Please announce if an application goes forward. It will be posted on herpes-coldsores.com where the members can send a considerable amount of email and letters to the FDA and government officials to hopefully help get it pushed through. We are really looking forward to this drug hitting the market asap and I believe putting it above the others is a really smart move. With HSV being so common, it will help generate a great deal of revenue that can be retained to be used on research for other deadly disease. It’s my personal hope that this strategy will save more lives in the long run, while helping millions of lives get back to normal faster. Once again, please send my gratitude to those involved.

I'm hoping it will keep the momentum going. I'll try to find the information on it again to refresh my memory. I know it works in a different way and will be superior to Valrex. Looks like this drug will hit the market before anything else if things keep going well. Lets cross our fingers.

[struggle83]

Anyone know how we can get involved in P3 trial or is it too early?

@Sweet7 - Thanks for the response. Your email is awesome and speaks for us all. I also can't find anything on the mechanism of action. Maybe they are keeping that hush for now so no other pharma's get the idea.

[helpiamconfused2]

Struggle, I'm pretty sure I read somewhere that Aicuris believes that this drug will work on HSV-1 as well. They may include testing during the Phase III trial. They are not saying anything at this time. The cool thing is that they are affiliated with Bayer and they it appears they are pushing this drug ahead of the others and trying to beat other pharma's to the market. I just sent them this email:

On behalf of the millions of sufferers of HSV, I want to say thank you to the scientist and staff who have worked so hard to bring this drug about. I hope that Aicuris will try to obtain a fast track status with the US FDA if possible. Please announce if an application goes forward. It will be posted on herpes-coldsores.com where the members can send a considerable amount of email and letters to the FDA and government officials to hopefully help get it pushed through. We are really looking forward to this drug hitting the market asap and I believe putting it above the others is a really smart move. With HSV being so common, it will help generate a great deal of revenue that can be retained to be used on research for other deadly disease. It’s my personal hope that this strategy will save more lives in the long run, while helping millions of lives get back to normal faster. Once again, please send my gratitude to those involved.

I'm hoping it will keep the momentum going. I'll try to find the information on it again to refresh my memory. I know it works in a different way and will be superior to Valrex. Looks like this drug will hit the market before anything else if things keep going well. Lets cross our fingers.

I will send a modified version of this myself. I encourage all others to do the same!

info@aicuris.com

[SuperManFace]

THANK YOU SWEET JESUS! ONCE THIS GOES INTO PHASE THREE TRIALS AND IS SUCCESSFUL WE WOULD BE CURED!!!! Thanks mamem for posting this! i almost am in tears! its funny how they said "We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus" are you kidding me? i would sign up for anything that remotely has a chance against this fucked up virus! This is great news fellow herpsters lets keep this research trial in our prayers. Hopefully this also forces other researchers working on a cure to hasten up!

LMAO! They are so innocent!

[SuperManFace]

"reduce viral load" this means active virus in blood right?

[LifeHurts]

Good. I sent a E-mail to. As i mention in many other posts we need to focus on one thing. And this thing is not a cure but can be so close to it as possible. So please put the "cure" thought aside it will take many years more and put effort instead of what is close to help us. Takaing a tablet a day and have normal living, what is the problem? Come one every one do like Sweet7 fight to help this company in diffrent way to reach out to us with this drug as soon as possible. Two month earlier in Phase II and mayby if we can help them will in the end maybe be 6-12 month earlier. We maybe talking about an drug 2012 that can help us living normal again. Biggest problem with this forum is many people only talk and dont do anything. I´m nit located in USA but if we get to gather and push FDA and the company we make more diffrence then talk talk

[struggle83]

"reduce viral load" this means active virus in blood right?

For HIV reduced viral load is blood borne virus. This is easy for them to detect and quantify. I don't know how they do it for HSV. I would assume that they are sacrificing the test animals and doing biopsies on the nerve tissue to deduce viral load.

[struggle83]

Good. I sent a E-mail to. As i mention in many other posts we need to focus on one thing. And this thing is not a cure but can be so close to it as possible. So please put the "cure" thought aside it will take many years more and put effort instead of what is close to help us. Takaing a tablet a day and have normal living, what is the problem? Come one every one do like Sweet7 fight to help this company in diffrent way to reach out to us with this drug as soon as possible. Two month earlier in Phase II and mayby if we can help them will in the end maybe be 6-12 month earlier. We maybe talking about an drug 2012 that can help us living normal again. Biggest problem with this forum is many people only talk and dont do anything. I´m nit located in USA but if we get to gather and push FDA and the company we make more diffrence then talk talk

Unfortunately, you cannot push the FDA. And I wouldn't hold my breath for a 2012 drug on the open market. These things take a lot of time. It is frustrating.

[helpiamconfused2]

Unfortunately, you cannot push the FDA. And I wouldn't hold my breath for a 2012 drug on the open market. These things take a lot of time. It is frustrating.

s83, I agree - with modification - that we cannot push the FDA. Admittedly I am not an expert on this or anything for that matter, but if the AICURIS drug is shown to be "superior" to Valtrex, the drug can hit the market while phase III is conducted. That way (obviously) it would be available for us as soon as they started Phase III. Now, with that said, I don't know if we can facilitate that process. I think if we can get the buy in of AICURIS to pursue this and we, in unison, petition the FDA to allow them to do so maybe we could get it done. I don't know if this is a pipe dream or not. Also, they could pursue fast-tracking it...

Hey, if it stops all viral shedding, and reduces viral load I don't know why in the heck they wouldn't be all for it given the link of HSV to HIV... Anyway, as you can tell, I am into the petitions. If we knew more about the phase II results (I am sure it is too early), we could team up with AICURIS to pursue this...

Open to suggestions or maybe we wait until we hear from AICURIS.

[Sweet7]

Actually what I meant by pressuring the FDA was as Help said, in unison, we can petition the FDA to move this drug along. The petitions are a great way to do this if we can get enough people to sign them. But, we do have to see what Aicuris is going to do before we know what actions we can take to help them.

[struggle83]

Actually what I meant by pressuring the FDA was as Help said, in unison, we can petition the FDA to move this drug along. The petitions are a great way to do this if we can get enough people to sign them. But, we do have to see what Aicuris is going to do before we know what actions we can take to help them.

I am for whatever it takes to get this possible treatment to market sooner.

[soul5821]

What aobut if we can contact another countries like Canada or Mexico???., it will be easy for us to get the drug into the usa from this other countries...

[Movingslowly]

I sent a letter to Aicuris. Just thanking them for even considering finding a better treatment for HSV. Some other information also provided. This drug, if passes through all the phases will most likely be best of treatments until a cure is available. I don't see a cure coming through until another 7-10 years do to the length of conducting a research. Maybe even longer if money becomes an issues. We still need to support the cure and encouraging people to sign the petitions, especially the that's directly sent to NIH. All the petitions are important and it's a free way of pushing our concerns for a cure. The more we push the issue to find a cure for HSV the more likely we will get positive results. I'm still thankful for Aicuris and their research toward a more effective treatment.