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TVEC -- A live attenuated HSV-1 vaccine which has completed phase III


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......However, the clinical trials were testing its efficacy against melanoma, not as an HSV-1 vaccine:

https://en.wikipedia.org/wiki/Talimogene_laherparepvec

Here we have a live attenuated HSV-1 vaccine with some genes deleted and some genes added. Considering that this has made it through the clinical trials process for melanoma with a decent safety profile, would it not be worth pushing for a clinical trials to investigate its efficacy against HSV-1? I asked Bill Halford about it, here is the dialog:

======================================

Hi Bill,

Have you seen this before:

https://en.wikipedia.org/wiki/Talimogene_laherparepvec

It is an attenuated HSV-1 vaccine used to combat skin cancer, which I think has already completed phase III clinical trials. I have not read the papers, but assuming that the vaccine was well tolerated, shouldn’t this be a point against those who claim that a live attenuated herpes vaccine would be too dangerous?

Also what are your thoughts on the efficacy of T-VEC as it stands as a herpes prophylactic/treatment?

Thanks!

=======================================

Hi TVEC,

Your comment is spot on. Yes, we have put live-attenuated HSV-1 mutants into the central nervous system of human beings who have an incredibly aggressive form of brain cancer called glioblastoma. Glioblastoma is a horrible condition and is much like pancreatic cancer….essentially a death sentence. So, the use of attenuated viruses to clean up a surgical resection site of residual tumor cells (some of the attenuated viruses are HSV-1 ICP34.5- mutants but other attenuated RNA viruses have been tested too) as a means to prevent the glioblastoma from recurring after surgery makes perfect sense. This is a remarkable treatment and has saved peoples’ lives over the past 10+ years. The use of oncolytic viruses (cancer-attacking viruses) is still in its infancy, but when it works it is miraculous. All that said, getting back to TVEC’s excellent point………..if we can use attenuated HSV-1 viruses to combat cancer (particularly brain cancers), then it stands to reason that someone getting a shot of a live-attenuated HSV-1 vaccine in the skin of their buttock should not be nearly as big of a deal. TVEC, I wholeheartedly agree…….there is no sane reason why we should not be testing live-attenuated HSV-1 and HSV-2 vaccines in people post-haste.

– Bill H.

==================================

Hi Bill,

thanks for your response ! Still curious about what you think about my second question… could TVEC be an effective HSV1 vaccine if used off label?

==================================

Hi Tvec,

In theory, TVEC could be used as a live-attenuated HSV-1 vaccine. However, to know would require study, and I am unaware that such studies have been conducted.

– Bill H.

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Wow this is great news. However, the fact that they haven't looked much into it is a bit discouraging. This still sounds promising though if they ever decide to start conducting studies for a hsv1 vaccine.

I may be a bit ignorant towards this subject , but if scientists were ever to create a vaccine for hsv1 would it be easier for them to be succesful because the virus is not as aggresive as hsv2? or it doesn't make a difference since the virus tends to hide in the same spot as hsv2 genital?

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Definitely considering writing a letter to Amgen to see if they are planning or willing to run HSV1 trials. To those that know about the clinical trials process, how much of the process can be skipped once a drug is already approved for an unrelated treatment?

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Another Q for you all: in the case that Amgen was unwilling to run trials, and assuming TVEC was FDA approved for melanoma treatment (it is very likely to receive approval soon), would it be legal for a doctor to administer this vaccine off label?

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......However, the clinical trials were testing its efficacy against melanoma, not as an HSV-1 vaccine:

https://en.wikipedia.org/wiki/Talimogene_laherparepvec

Here we have a live attenuated HSV-1 vaccine with some genes deleted and some genes added. Considering that this has made it through the clinical trials process for melanoma with a decent safety profile, would it not be worth pushing for a clinical trials to investigate its efficacy against HSV-1? I asked Bill Halford about it, here is the dialog:

======================================

Hi Bill,

Have you seen this before:

https://en.wikipedia.org/wiki/Talimogene_laherparepvec

It is an attenuated HSV-1 vaccine used to combat skin cancer, which I think has already completed phase III clinical trials. I have not read the papers, but assuming that the vaccine was well tolerated, shouldn’t this be a point against those who claim that a live attenuated herpes vaccine would be too dangerous?

Also what are your thoughts on the efficacy of T-VEC as it stands as a herpes prophylactic/treatment?

Thanks!

=======================================

Hi TVEC,

Your comment is spot on. Yes, we have put live-attenuated HSV-1 mutants into the central nervous system of human beings who have an incredibly aggressive form of brain cancer called glioblastoma. Glioblastoma is a horrible condition and is much like pancreatic cancer….essentially a death sentence. So, the use of attenuated viruses to clean up a surgical resection site of residual tumor cells (some of the attenuated viruses are HSV-1 ICP34.5- mutants but other attenuated RNA viruses have been tested too) as a means to prevent the glioblastoma from recurring after surgery makes perfect sense. This is a remarkable treatment and has saved peoples’ lives over the past 10+ years. The use of oncolytic viruses (cancer-attacking viruses) is still in its infancy, but when it works it is miraculous. All that said, getting back to TVEC’s excellent point………..if we can use attenuated HSV-1 viruses to combat cancer (particularly brain cancers), then it stands to reason that someone getting a shot of a live-attenuated HSV-1 vaccine in the skin of their buttock should not be nearly as big of a deal. TVEC, I wholeheartedly agree…….there is no sane reason why we should not be testing live-attenuated HSV-1 and HSV-2 vaccines in people post-haste.

– Bill H.

==================================

Hi Bill,

thanks for your response ! Still curious about what you think about my second question… could TVEC be an effective HSV1 vaccine if used off label?

==================================

Hi Tvec,

In theory, TVEC could be used as a live-attenuated HSV-1 vaccine. However, to know would require study, and I am unaware that such studies have been conducted.

– Bill H.

The irony in all of this is that TVEC is part of the Amgen portfolio because they purchased a company called BioVex which had two lead vaccines TVEC and a live attenuated HSV-2 vaccine named ImmunoVexHSV-2 that completed phase I trials: http://www.herpes-coldsores.com/messageforum/threads/save-immunovex.49641/

Amgen promptly killed the HSV-2 vaccine and has shown no interest since in pursuing anything for HSV outside of a cancer indication. Since Amgen would have to initiate the trial it is very unlikely there will be a specific HSV related trial of TVEC. They would simply resurrect their Herpes specific vaccine if they were interested in that market.

For the second part of your question. Cancer treatments are a funny thing. Typically they carry a label that prevents doctors from prescribing them willy-nilly and TVEC is experimental enough that (even after commercial release) it can probably only be administered in a cancer treatment center by an oncologist. If you can get past all of those hurdles (i.e. find an oncologist willing to prescribe it off-lable, in a research oriented cancer center) the price would be $10k or more to get an injection (since it wouldn't be covered by insurance).

---

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The irony in all of this is that TVEC is part of the Amgen portfolio because they purchased a company called BioVex which had two lead vaccines TVEC and a live attenuated HSV-2 vaccine named ImmunoVexHSV-2 that completed phase I trials: http://www.herpes-coldsores.com/messageforum/threads/save-immunovex.49641/

Amgen promptly killed the HSV-2 vaccine and has shown no interest since in pursuing anything for HSV outside of a cancer indication. Since Amgen would have to initiate the trial it is very unlikely there will be a specific HSV related trial of TVEC. They would simply resurrect their Herpes specific vaccine if they were interested in that market.

For the second part of your question. Cancer treatments are a funny thing. Typically they carry a label that prevents doctors from prescribing them willy-nilly and TVEC is experimental enough that (even after commercial release) it can probably only be administered in a cancer treatment center by an oncologist. If you can get past all of those hurdles (i.e. find an oncologist willing to prescribe it off-lable, in a research oriented cancer center) the price would be $10k or more to get an injection (since it wouldn't be covered by insurance).

---

Yeah, I remember reading about the immunovex and how it was just left up in the air.... Maybe not left up but more like buried. I feel like these companies just take what will make them and their investors big bucks and trash being relatively more virtuous.

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  • 2 months later...

TVEC was approved. I'm wondering the same thing others are--if you have HSV-1 but don't have cancer what would it do? Could it be used as a therapeutic vaccine for those infected with HSV-1? The cost is 65,000 as per the news release articles.

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eh, the story of how AmGen bought out this and discontinued its HSV therapeutics use only to focus on cancer makes me sick.   For a moment, I thought this was something new and I was excited.  But such a sour taste in the mouth for how a company buries the progress of something with such potential so they can grubbily do their cancer work.  ehhhh.  whatever.  I don't care.  This is a sore story for me. Sorry.

 

And $65,000!!! That's outrageous!! Maybe that's normal for a cancer treatment that is covered by insurance to some degree but damn.  And to get insurance to cover some of that wouldn't work because it'd be an off label use.  I'm just guessing.   Sheesh, life.   I'd like to see a clinical human trial on efficacy with HSV1.   They'd make more money off of it.  Idk why they wouldn't venture into that world?

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Would doctors want to administer this as an off label use, is that a thing that is done with other treatments? How would they know if it is effective against hsv1 and would anyone be willing to have the vaccine without knowing the potential side effects as an off label use? I assume they would be the same or similar in cancer vs non cancer sufferers?

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I thought this treatment (engineered HSV1) is much different than the regular HSV1.  Or different than the HSV1 they were using in clinical trials before AmGen just stopped it.   I don't really know.   I want to say it will work but I don't know how what they removed affects the body's immune response.  But it is live-attenuated which is much different than what's in the works now. (minus hsv529)

Gabapentin/neurontin is a drug that has tonnes of off label uses by doctors.

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The irony in all of this is that TVEC is part of the Amgen portfolio because they purchased a company called BioVex which had two lead vaccines TVEC and a live attenuated HSV-2 vaccine named ImmunoVexHSV-2 that completed phase I trials: http://www.herpes-coldsores.com/messageforum/threads/save-immunovex.49641/

 

Amgen promptly killed the HSV-2 vaccine and has shown no interest since in pursuing anything for HSV outside of a cancer indication. Since Amgen would have to initiate the trial it is very unlikely there will be a specific HSV related trial of TVEC. They would simply resurrect their Herpes specific vaccine if they were interested in that market.

 

For the second part of your question. Cancer treatments are a funny thing. Typically they carry a label that prevents doctors from prescribing them willy-nilly and TVEC is experimental enough that (even after commercial release) it can probably only be administered in a cancer treatment center by an oncologist. If you can get past all of those hurdles (i.e. find an oncologist willing to prescribe it off-lable, in a research oriented cancer center) the price would be $10k or more to get an injection (since it wouldn't be covered by insurance).

 

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Pathetic, pathetic, pathetic! Some of these people need to be shot. We almost factually know how to prevent HSV with live attenuated vaccines, but theres a big conspiracy to avoid this for as long as possible. 

I fear there won't be a working vaccine until Halford makes it. And who knows if that will even by in our lifetime. 

I don't think any other entity really cares about actually curing this. 

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