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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??

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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

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

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[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 ?

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I wish this trial was in my area I jump at it

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

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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.

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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.

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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

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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)

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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.

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What happened?

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

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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.

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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!

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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!!

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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 ;)

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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

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

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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

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

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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.

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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?...

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Estimated Study Completion Date: March 2011

:wavey:

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