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Dp Doom

Monoclonal Antibody against HSV 2 goes in Clinical Phase2

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Dp Doom

Hey Guys,

i stopped visiting this Site since a few month. Just went here again because following news are not posted here yet. Maybe this is interessting for some of you. I already wrote about this 1,5 years ago:

EU: https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000880-26/DE
US: https://clinicaltrials.gov/ct2/show/NCT04165122

 

Edited by kill.hsv(not Kenny)

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Voyager2

@kill.hsv. Thanks, this is interesting!

Just skimmed this write-up in clinicaltrials.gov and it looks like a pretty elaborately designed (and expensive) 180-day phase 2 trial for a therapeutic "monoclonal antibody" one-time-only injection to treat HSV-2. I have no idea what that is but the people who developed this treatment, apparently in Germany, must have HIGH confidence in it, to go to all this trouble.

The analysis is to be wrapped up in September 2021.

If it goes well, we'll likely be hearing more before it wraps up.    

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MikeHerp
On 11/17/2019 at 8:29 PM, kill.hsv(not Kenny) said:

Hey Guys,

i stopped visiting this Site since a few month. Just went here again because following news are not posted here yet. Maybe this is interessting for some of you. I already wrote about this 1,5 years ago:

EU: https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000880-26/DE
US: https://clinicaltrials.gov/ct2/show/NCT04165122

 

Thanks.  I didn't know that this would also be tested in the EU.  That's new info for me.  

I'm curious about this treatment.  Hope it goes well.  

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Dp Doom

Different study centers in germany doing the Phase 2 trial, started this month.

 @Voyager2: Right, its developed in germany for, i think more than a decade by NCT Heidelberg

Edited by kill.hsv(not Kenny)

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MJRX
2 hours ago, kill.hsv(not Kenny) said:

Different study centers in germany doing the Phase 2 trial, started this month.

 @Voyager2: Right, its developed in germany for, i think more than a decade by NCT Heidelberg

@kill.hsv(not Kenny) this question is a little bit off topic and my apologies for that. But do you have any idea when the FDA approves a medicin how long it takes before it’s available in the EU.

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Dp Doom

@MJRX Sorry, i have no idea. Btw. i think this is a bit more complicated and should be discussed in a seperate thread (maybe compare the delay between FDA and EMA approval for GsK Shingrix. But i think it depends on the medicin/drug/etc.).

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MJRX
Just now, kill.hsv(not Kenny) said:

@MJRX Sorry, i have no idea. Btw. i think this is a bit more complicated and should be discussed in a seperate thread (maybe compare the delay between FDA and EMA approval for GsK Shingrix. But i think it depends on the medicin/drug/etc.).

Thank you for your anwser!

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hk81

Does someone know where to find informations/results of phase2 of this trial? I have searched, but I haven't found anything.

It is interesting that the trial takes place in my country. But I do not pass the admission criteria, as I do have HSV1 genital and not HSV2 :(

It's also unclear to me how this treatment works. Is it a 1 time injection? Or a treatment with long half-life, to be repeated periodically?

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Dp Doom

There are no results yet because they just start the trial. 

Edited by kill.hsv(not Kenny)

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Dp Doom

Phase 1 is always with healthy volunteers/participants. They testet safety and dosis escalation with a high dose and it was we tolerated by the participants. So they continue with phase 2 now. 

Edited by kill.hsv(not Kenny)

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iFdUp

It is fascinating to me that all these treatments are coming out of the woodwork pitching potential cures, so many in the past handful of months.

The race is on, only one person can be the first to cure herpes. As well as the one to profit. 

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hk81

I am trying to get in touch with them for a few clarifications:

- is anogenital HSV1 not a criteria for being eligible to the trial?

- why is herpes keratitis included as an exclusion criteria?

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hk81

Well, I have received the 1st answer 3 days ago. No answers to my questions; I was only told that the trial runs only in German cities due to the frequent controls required.
I replied that I do live in Germany, but so far I was not contacted again.

It's the first time that I write for a trial; so I do wonder if they treat candidates as Guinea Pigs or as People.

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Dp Doom
1 hour ago, hk81 said:

t's the first time that I write for a trial; so I do wonder if they treat candidates as Guinea Pigs or as People.

Definetly not as Guinea pics. Strange, to think that. This is a very well prepared and professional trial. If you want to participate, do the online check and apply here: https://genitalherpes-studie.de/

 

Edited by kill.hsv(not Kenny)

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iFdUp

NCT heidelberg appears to be the German equivalent of the Fred Hutch center. 

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hk81

@kill.hsv(not Kenny)
I first needed to know if they would consider also someone with genital HSV1. That's the reason why I contacted them.

After that, I would probably get an opinion from a department of infectious diseases in my city, before applying.

 

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Dp Doom
57 minutes ago, hk81 said:

@kill.hsv(not Kenny)
I first needed to know if they would consider also someone with genital HSV1. That's the reason why I contacted them.

After that, I would probably get an opinion from a department of infectious diseases in my city, before applying.

 

Maybe do the only check in. If you pass the criteria, they will come back to you within days. Then you can call or write and they will answer you questions. 

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hk81

Thanks. I have sent my application.

They do not have a study center in Munich, so I'm not sure if I have a chance.

 

Do you plan to participate too?

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Dp Doom
5 hours ago, hk81 said:

Thanks. I have sent my application.

They do not have a study center in Munich, so I'm not sure if I have a chance.

 

Do you plan to participate too?

Next is in Frankfurt. You will have to travel there a few times.

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hk81

I have been trying to search for an information in internet but I cannot find it.

I suppose that the therapy with monoclonal antibodies consists in an injection and it does have a limited period of protection, after which it has to be injected again.

How long is the protective effect supposed to last? I have not seen any study on that. All the articles that I have found seem to study the pre-exposure and post-exposure efficacy.

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vzhe
5 hours ago, hk81 said:

I have been trying to search for an information in internet but I cannot find it.

I suppose that the therapy with monoclonal antibodies consists in an injection and it does have a limited period of protection, after which it has to be injected again.

How long is the protective effect supposed to last? I have not seen any study on that. All the articles that I have found seem to study the pre-exposure and post-exposure efficacy.

monoclonal antibodies have a half-life of up to 4 weeks, so dosing every 2-4 weeks would make sense.

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Dp Doom

I think, this ist not only about how long the antibodies stay in the body. Could be also possible that it is reprogramming the immunesystem and make it able to produce effective antibodies by itself. We will see what it does and if it works in the way the developers think. Btw. the research name for the antibodies is/was "mab hu2c". If someone wanna search for more informations.

 

Edited by kill.hsv(not Kenny)

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vzhe
16 hours ago, kill.hsv(not Kenny) said:

I think, this ist not only about how long the antibodies stay in the body. Could be also possible that it is reprogramming the immunesystem and make it able to produce effective antibodies by itself. We will see what it does and if it works in the way the developers think. Btw. the research name for the antibodies is/was "mab hu2c". If someone wanna search for more informations.

 

doubtful. how would that work?

Edited by vzhe

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