Sign in to follow this  
Followers 0
WoodlandWalker

AIC316 Phase II Trial

99 posts in this topic

does anyone know anything else about this? if successful, would it just work as another anti-viral and not be an actual 'cure' as such??

Share this post


Link to post
Share on other sites

This is what AiCuris posts about AIC316

This is what AiCuris posts about AIC316. Not a cure but perhaps helps with viral shedding. That would be a step forward.

AiCuris successfully completed phase I for novel herpes compoundAiCuris November 6, 2009transp.gifWuppertal, November 6, 2009 – AiCuris today announced that three phase I studies with its novel compound AIC316 for the treatment of herpes simplex virus infections have been completed successfully. AIC316 is a first-in-class helicase-primase inhibitor.

More than 120 volunteers were exposed in single-dose, multiple-dose and food interaction studies. The drug was generally well-tolerated and showed high and long-lasting exposures in the human subjects.

"We now have all data to enter into phase II, and we are pleased to have obtained evidence for favourable pharmacokinetics of AIC316 which will allow a convenient dosing regimen in patients”, said Prof. Helga Rübsamen-Schaeff, CEO of AiCuris. “According to AiCuris’ strategy to focus on antibacterial and antiviral substances with resistance-breaking properties only, AIC316 represents a novel chemical class and has a mode of action which is different from the drugs currently available for the treatment of herpes simplex.”

“From what we have observed so far, our compound has the potential to become a next-generation therapy for episodic and suppressive treatment of herpes simplex virus infections”, explained Dr. Manickam Rangaraju, CMO of AiCuris. “With current herpes therapies, suppression of viral shedding in genital herpes and hence prevention of disease transmission is not sufficiently achieved. Furthermore, resistance may develop upon long-term use in immune compromised individuals. Therefore, there is a need for more efficacious, well-tolerated as well as resistance-breaking treatment options. Such drugs should also offer benefits with respect to ease of administration.”

About herpes

Herpes simplex viruses (HSV) are widespread in the human population (seroprevalence up to 100%, depending on geographic area and subpopulation), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly being transmitted sexually. However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries. Both labial and genital herpes are generally self-limiting and can recur frequently. HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV. In immune compromised individuals large and painful ulcerations may result, and newborns infected with HSV are at risk of developing herpes encephalitis. Most of the current herpes drugs inhibit a specific viral enzyme, the DNA polymerase. They share the same mode of action and are therefore very similar in their efficacy. Also, cross-resistance can occur.

About AiCuris

AiCuris GmbH & Co KG (the name is derived from: anti infective cures), is a spin-out from Bayer HealthCare. It is a privately held company located in Wuppertal, Germany. AiCuris is devoted to research and clinical development of novel, resistance-breaking drugs for the treatment of Cytomegalovirus (HCMV), Herpes Simplex, Hepatitis B, HIV and Hepatitis C as well as resistant Gram positive and Gram negative bacterial infections in hospitals. Furthermore, the portfolio comprises two immune modulators.

Contact:

AiCuris GmbH & Co. KG

Sandra Wildhagen

Friedrich-Ebert-Str. 475/Building 302

42117 Wuppertal

Phone +49 202 317 63 0

Fax +49 202 317 63 1601

E-Mail press@aicuris.com

Web www.aicuris.com

dbpc inf

Share this post


Link to post
Share on other sites

great news!! we can hope it goes better than asp2151 trials..iwish they had a center in my area

Share this post


Link to post
Share on other sites

[报价=新技术开发中心; 130370]好消息!我们希望它去比asp2151试验.. iwish他们在我区一中心[/帖]

what's different with asp2151?

who know news about asp2151 ?

Share this post


Link to post
Share on other sites

What the hell is first-in-class helicase-primase inhibitor?:confused:

Share this post


Link to post
Share on other sites

From what I have read, a Helicase is a protean that separates the two strands of DNA, that form the famous double helix, ready for them to be copied. One of these strands can be copied directly by the DNA polymerise to form one of the new strands of DNA. However DNA polymerise can only copy DNA in one direction, so the DNA of the second strand has to be prepared by the Primase before it can be copied by the DNA polymerise. (DNA polymerise is the target of drugs such as Acyclovir etc.)

I think that in the Herpesviruses the Helicase and the Primase form one combined protein, hence the Helicase- Primase. I guess that it is this protein itself that is targeted by the drug, but I couldn’t really say that the DNA or mRNA, that produces this protein, definitely isn’t the target of the drug.

If anyone knows more I would like to know.

Share this post


Link to post
Share on other sites
I guess that it is this protein itself that is targeted by the drug, but I couldn’t really say that the DNA or mRNA, that produces this protein, definitely isn’t the target of the drug.

based on how it was developed they scientists who developed the drug may not know either.

Share this post


Link to post
Share on other sites

Indian, Oregon, Texas, or Washington--PLEASE SIGN UP

United States, Indiana

Indiana University School of Medicine, Office for Research

Indianapolis, Indiana, United States, 46202

United States, Oregon

Westover Heights Clinic

Portland, Oregon, United States, 97210

United States, Texas

University of Texas Health Science Centre, Center for Clincial Studies

Houston, Texas, United States, 77030

United States, Washington

University of Washington, Virology Research Clinic

Seattle, Washington, United States, 98104

Share this post


Link to post
Share on other sites
What the hell is first-in-class helicase-primase inhibitor?:confused:

it means it's a helicase-primase inhibitor which prevents the virus replicating (as per the explanation above) and it's the first compound developed in this area, and looks like it might be first to market -- vs the ASP2151 product which seems to have had some setbacks. There was a BILS candidate also which has gone quiet. (Boehringer Ingelheim)

Share this post


Link to post
Share on other sites
From what I have read, a Helicase is a protean that separates the two strands of DNA, that form the famous double helix, ready for them to be copied. One of these strands can be copied directly by the DNA polymerise to form one of the new strands of DNA. However DNA polymerise can only copy DNA in one direction, so the DNA of the second strand has to be prepared by the Primase before it can be copied by the DNA polymerise. (DNA polymerise is the target of drugs such as Acyclovir etc.)

I think that in the Herpesviruses the Helicase and the Primase form one combined protein, hence the Helicase- Primase. I guess that it is this protein itself that is targeted by the drug, but I couldn’t really say that the DNA or mRNA, that produces this protein, definitely isn’t the target of the drug.

If anyone knows more I would like to know.

there's some technical journal papers out there on it by the bayer team that kicked it off (now aicuris) -- i've got a bunch of them somewhere that the lead researcher sent me, but can't put my hands on them -- just google 'gerald kleymann helicase primase inhibitor' and see what comes up.

Share this post


Link to post
Share on other sites

What happened?

What happened to this trial? It was supposed to launch in Jan for Phase 2 but seems stalled?

Share this post


Link to post
Share on other sites
What happened to this trial? It was supposed to launch in Jan for Phase 2 but seems stalled?

Looks like they haven't started yet... Here's the most recent news about AiCuris and only completion of phase I is mentioned there: http://www.genengnews.com/news/bnitem.aspx?name=80111604

Good news is that they currently seem to have no funding problems, they have raised 55 euros for their research.

Share this post


Link to post
Share on other sites

good article, so this sound like it would be a supressive med. well i hope when trials start it begins very quickly (who wouldnt want to be apart of this!) and there is no bad side effects!

55M euro is alot of friggen money!

Share this post


Link to post
Share on other sites

It's back on

Recruiting time! NIH change in status as of April 21!!

Please anyone if you can get in these trials do it!!

Share this post


Link to post
Share on other sites
Recruiting time! NIH change in status as of April 21!!

Please anyone if you can get in these trials do it!!

this being the link in post 1: http://clinicaltrials.gov/ct2/show/study/NCT01047540?term=AIC316&rank=1

Contacts

Contact: Susanne Stoelben, MD, MPH +49-202-31763 ext 2119 Susanne.stoelben@aicuris.com

Locations

United States, Indiana

Indiana University School of Medicine, Office for Research Not yet recruiting

Indianapolis, Indiana, United States, 46202

United States, Oregon

Westover Heights Clinic Recruiting

Portland, Oregon, United States, 97210

United States, Texas

University of Texas Health Science Centre, Center for Clincial Studies Not yet recruiting

Houston, Texas, United States, 77030

United States, Washington

University of Washington, Virology Research Clinic Not yet recruiting

Seattle, Washington, United States, 98104

Looks like all the guinea pigs are in the US ;)

Share this post


Link to post
Share on other sites

If anyone can sign up for this please do and then report back to us.Its amazing that with all these trials going on that not one test subject has shared theyre experience on this site(if im mistaken please correct me),there must be some kind of confidentiality clause,but still,this site is confidential.I wish I lived near theyre recruiting

Share this post


Link to post
Share on other sites

Now recruiting in Texas and Indiana as well! Go team!

Share this post


Link to post
Share on other sites

recruiting

FYI, everyone, I inquired to AiCuris back in January. I am too far away to do these trials, but wanted to let you know that they responded today to see if I would still be interested. So they are on the move!

If you can, please send inquiries to susanne.stoelben@Aicuris.com

Share this post


Link to post
Share on other sites

i live in ny , i will love to be part of the trials

Share this post


Link to post
Share on other sites

can you go to Indianapolis? as they are in phase II, I wouldn't think it should be as risky as going into an unknown phase I trial.

Share this post


Link to post
Share on other sites
can you go to Indianapolis? as they are in phase II, I wouldn't think it should be as risky as going into an unknown phase I trial.

I can , there is only a 10 hours drive, but I wondering how many days I have to stay there for each visit, or u think there are daily basis visits?...

Share this post


Link to post
Share on other sites

Estimated Study Completion Date: March 2011

:wavey:

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!


Register a new account

Sign in

Already have an account? Sign in here.


Sign In Now
Sign in to follow this  
Followers 0

  • Latest Buzz

    • Peeved
    • Lisajd
      We have all been where you are so please understand that you will be ok it does take time.  You'll get plenty of support and information from this site but first of all what type do you have exactly and how are you diagnosed. What I would suggest to you is do some research and learn as much as you can about the virus because I really will help and it will help you to understand what you need to do going forward in terms of being able to live a normal life because many people have this and it shouldn't stop me from doing anything that you have always wanted to do. 
    • TravelingTeacher
      Was just diagnosed yesterday and I am on the verge of a complete breakdown. 
    • Beachguy
      Hi, I have been to several doctors including 2 dermatologist to evaluate a rash (Not HSV). This has been very persistent and on my neck for over a month.  The medicine they prescribed help but very slowly. I also recently picked up Terri Warren's ebook and I saw she suggested burow's solution AKA Domeboro Astringent Solution. (Available everywhere OTC) This stuff is amazing after 3 application it reduced the rash over 90 percent. According to the book and medicine it treats HSV, Shingles, and general rashes.  Just wanted to share with everyone and hope if helps anyone. BeachGuy  
    • BoatyMcBoatface
      I think of it like bedbugs in NYC. You will think, "I'm not dirty..my place is clean. I'll never get bedbubgs." They're everywhere in the city. Subway benches, offices, stores, movie theaters..etc.. I have had them. Several people I know have had them too and there is shame also with mentioning you have them! I remember the only thing I had worry about telling a guy if he stayed over was the bedbugs. It was a little like disclosing an STD lol. Now I would happily trade herpes for bedbugs.
    • herpdeherpherp
      Hi A'lanna, Correct me if I'm wrong here, male readers, but I think men tend to be fixers. When we women come to them upset or with problems, it makes them upset, and they want to make us happy again. So they start suggesting solutions or they try to brighten our mood - if this doesn't work, they get frustrated and feel useless. Whereas we women mostly need/want to talk problems out - we want to vent, express how we feel, and then we feel better, regardless of whether the problem is fixed or not. To men, this looks like we're going round in circles  Perhaps you could try asking him for exactly what you need/want when you feel down? E.g. "could you please listen to me/hug me" and once he's done it, thank him and tell him it helped? Him saying he "always has to lift you up from a bad mood" sounds to me like he cares about you and wants to protect/help you. He feels personally responsible when you're sad. He wants to help, he wants to make you happy, but is frustrated because he doesn't know how. Please disregard if not helpful. Just my two cents from noticing my similar patterns with previous exes. One used to freak out whenever I cried about something. When I told him how helpful it was when he just gave me a hug, or sat and listened, he seemed to feel much better... he just needed to feel useful.
    • crazypuglady
      Thank you so much for your responses! I have been looking into chinese medicine and keen to try it.
    • Free73
      Hi there wb, I am also an avid weight lifter and have genital herpes. I also take Optimum Nutrition Gold Standard whey. Like you, my outbreaks have been pretty constant over the last 12 months after many years of having few, if any noticeable outbreaks. I'm 43. I would be surprised if it's the protein shakes. The ratio of lysine to arginine in ON's gold standard whey is about 9 grams per 100 grams vs 2 grams per 100 grams. That's a 4:1 ratio of Lysine to Arginine which is very high. The hydrocortisol could be a problem. I have read that oral steroids can suppress the immune system, so perhaps get some more information on that from your doctor. What is your current exercise and training routine? You want to make sure that you are not overtraining. Lifting weights will stress the body. Exercise is good for the immune system, but overdo it and it will supress the immune system. I have been lifting weights for 20 years, but as I've gotten older, I know that my body is struggling to keep up, particularly after contracting herpes. I lift pretty heavy and use a four day split routine. I primarily use free weights and work in a rep range of 4-7, so I am lifting heavy and really taxing the body. I definitely think it plays a role in the frequency of outbreaks, because my training hasn't really slowed down in intensity as I've gotten older, yet the body requires more recovery time as you get older. I also think that because you recently started lifting, it's causing a shock to your body and immune system. Even though you have made these improvements to the quality of your life by starting to exercise and giving up smoking etc., you have introduced a new 'shock' to your body and your immune system is possibly still trying to get used to it. For me, I know that my weight training probably aggravates the herpes and my outbreaks, but it also makes me feel great both physically and mentally and i'm not prepared to give that up simply to lessen the frequency of outbreaks. What I do need to do is give my body more recovery time and get better sleep.
    • Blahdittilyblah
      I think it's a good idea to consider how long you have been in some sort of a relationship and where you see this going. If it hasn't been too long then let it ride for a little longer no need to disclose if your not sure where things should go if you didn't have this issue. If it's been a while then disclose. I wouldn't wait until you both are so emotionally invested that it may cloud ones decision or hurt really bad if rejected. It's a difficult thing to judge but if you feel it may go to a full blown relationship involving sex then tell him if he likes you as much as you do him he will be ok with it if not then you saved yourself some heartache. 
    • Heart1
      Hi Choosehappy,  I'm so sorry to hear your story. I don't know much about OCD but this website will help you realize that you are not alone with hsv. There are a lot of people here who can provide you with support and help educate you about ways to cope. We all had the same emotions in the beginning. We all had our first week. It will get better, I promise.  I suggest visiting the chat room, I have found that to be most helpful. You will find many people who will listen to your story and help answer your questions. Just know that you will get through this!
  • Featured