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Some more info about Genocea vaccine

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oneday

Genocea’s GEN-003 is not a herpes cure at the moment

December 3, 2012

in Herpes Cure and Research

GEN-003-trials.jpgGEN-003 is not being marked as a herpes cure quite yet

Genocea’s GEN-003 is not a herpes cure but rather a “Therapeutic Vaccination” for the moment. Don’t be discouraged because this is a step in the right direction.

In an effort to find a cure for herpes, Genocea has received a lot of attention with its GEN-003 vaccine and clinical trials. At the moment, there seems to be some unwarranted expectations of what they are actually working on. Hopefully, with this update, there will be a better understanding.

First, let’s take “Herpes Cure” off the table for the time being. Genocea cannot market their GEN-003 as a “Cure” to the FDA at this time. It has to be worded carefully. Instead, the vaccination is referred to as a “Therapeutic Vaccination.”

Before we get to what this all means, let’s first explain the stages of a clinical trial for the FDA. They usually are in 3 stages:

  1. Testing for Safety – This is always done after testing on animals like mice and guinea pigs. If monkey testing is successful then things look good because their DNA is closest to ours.
  2. Efficacy – A drug (especially vaccination) has to be working at 75% or greater efficacy to go to market. If lower, it goes back to the drawing board. This is done on people with a small testing pool (Say 150) to test the dosage.
  3. The Big Rollout – This is a much wider testing pool of 1000’s of people to test the efficacy. This is used to shore up the data from the efficacy testing in phase 2. This phase is also what determines if it goes to market.

Each phase is reported to the FDA and each phase can last a year but phase 1 and phase 2 can go on simultaneously to lessen the time between phases. Genocea is on phase 1 & 2. After phase 2 is completed, drug companies will apply for a fast track with the FDA. If approved, they move on to phase 3 if the 75% efficacy holds true.

Basically, this therapeutic vaccination will hopefully work in 2 ways. It will reduce the chances of spreading herpes and reduce the chances of someone becoming infected with herpes. It will not kill the herpes virus.

Right now, GEN-003 is being targeted as another layer of protection against the herpes virus, specifically HSV2. If Valtrex is roughly 55% effective and a condom is roughly 30% effective in blocking the herpes virus then you are at 85%. If GEN-003 is 75% effective then with Valtrex, it can be close to the 100% effectiveness.

So, in a real world situation, say that Mark is dating Suzie. Mark does not have herpes but Suzie does. If they both took the Gen-003 vaccination, Mark’s chance of getting herpes is significantly reduced. Suzie, however, would still have the herpes virus. She would hopefully have fewer outbreaks and they would not be nearly as painful.

The vaccination will work similar to the HPV (Human papillomavirus) vaccination and will probably come in 3 injections that are 3 weeks apart. The herpes virus lives in your central nervous system. What they are trying to achieve is to actually pull the virus out of its home and treat it once out in the open.

We are lucky enough to have a member, let’s call her Lisa, who is a part of this clinical trial. She also has a lot of abbreviations after her name and works with drug companies. So, she knows all about clinical trials. She has received her 3 injections and says that she feels “Fantastic!”

How fast can we expect something? A very optimistic date is looking like late 2016, IF all goes well and they can get enough volunteers. They still can’t seem to get enough. People have been calling but some hang up once they find out this is not a “Cure.” To meet the criteria for this clinical study, you:

  • Cannot be co-infected. Only have HSV2 and not also have HSV1, hepatitis, HIV…etc
  • Not on steroids
  • Off suppressive therapy for 7 days.
  • Must contact them directly on ClinicalTrials.gov.

Yale and other drug companies, such as Cordon, are also in clinical trials for a herpes cure or a vaccination so the studies are on going. We will keep you updated on anything that looks promising!

http://www.hwerks.com/genocea-gen003-not-a-herpes-cure-at-the-moment/

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oneday

So if people want a rough date, they are saying approximately 2016 and this will not be a cure. Might as well live your life as best you can and not expect a cure anytime soon, but maybe more like 20 years.

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cupcakes12

Sounds great!! I wish I could participate but I have hsv1&2. 2016 isn't too far away.

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Dummy
Genocea’s GEN-003 is not a herpes cure at the moment

December 3, 2012

in Herpes Cure and Research

GEN-003-trials.jpgGEN-003 is not being marked as a herpes cure quite yet

Genocea’s GEN-003 is not a herpes cure but rather a “Therapeutic Vaccination” for the moment. Don’t be discouraged because this is a step in the right direction.

In an effort to find a cure for herpes, Genocea has received a lot of attention with its GEN-003 vaccine and clinical trials. At the moment, there seems to be some unwarranted expectations of what they are actually working on. Hopefully, with this update, there will be a better understanding.

First, let’s take “Herpes Cure” off the table for the time being. Genocea cannot market their GEN-003 as a “Cure” to the FDA at this time. It has to be worded carefully. Instead, the vaccination is referred to as a “Therapeutic Vaccination.”

Before we get to what this all means, let’s first explain the stages of a clinical trial for the FDA. They usually are in 3 stages:

  1. Testing for Safety – This is always done after testing on animals like mice and guinea pigs. If monkey testing is successful then things look good because their DNA is closest to ours.
  2. Efficacy – A drug (especially vaccination) has to be working at 75% or greater efficacy to go to market. If lower, it goes back to the drawing board. This is done on people with a small testing pool (Say 150) to test the dosage.
  3. The Big Rollout – This is a much wider testing pool of 1000’s of people to test the efficacy. This is used to shore up the data from the efficacy testing in phase 2. This phase is also what determines if it goes to market.

Each phase is reported to the FDA and each phase can last a year but phase 1 and phase 2 can go on simultaneously to lessen the time between phases. Genocea is on phase 1 & 2. After phase 2 is completed, drug companies will apply for a fast track with the FDA. If approved, they move on to phase 3 if the 75% efficacy holds true.

Basically, this therapeutic vaccination will hopefully work in 2 ways. It will reduce the chances of spreading herpes and reduce the chances of someone becoming infected with herpes. It will not kill the herpes virus.

Right now, GEN-003 is being targeted as another layer of protection against the herpes virus, specifically HSV2. If Valtrex is roughly 55% effective and a condom is roughly 30% effective in blocking the herpes virus then you are at 85%. If GEN-003 is 75% effective then with Valtrex, it can be close to the 100% effectiveness.

So, in a real world situation, say that Mark is dating Suzie. Mark does not have herpes but Suzie does. If they both took the Gen-003 vaccination, Mark’s chance of getting herpes is significantly reduced. Suzie, however, would still have the herpes virus. She would hopefully have fewer outbreaks and they would not be nearly as painful.

The vaccination will work similar to the HPV (Human papillomavirus) vaccination and will probably come in 3 injections that are 3 weeks apart. The herpes virus lives in your central nervous system. What they are trying to achieve is to actually pull the virus out of its home and treat it once out in the open.

We are lucky enough to have a member, let’s call her Lisa, who is a part of this clinical trial. She also has a lot of abbreviations after her name and works with drug companies. So, she knows all about clinical trials. She has received her 3 injections and says that she feels “Fantastic!”

How fast can we expect something? A very optimistic date is looking like late 2016, IF all goes well and they can get enough volunteers. They still can’t seem to get enough. People have been calling but some hang up once they find out this is not a “Cure.” To meet the criteria for this clinical study, you:

  • Cannot be co-infected. Only have HSV2 and not also have HSV1, hepatitis, HIV…etc
  • Not on steroids
  • Off suppressive therapy for 7 days.
  • Must contact them directly on ClinicalTrials.gov.

Yale and other drug companies, such as Cordon, are also in clinical trials for a herpes cure or a vaccination so the studies are on going. We will keep you updated on anything that looks promising!

http://www.hwerks.com/genocea-gen003-not-a-herpes-cure-at-the-moment/

Correct me if I'm wrong.. You do have to live in the area where they are hosting the trial right? I think thats a big part of the problem.. I would participate if I could fly somewhere.. hell I would do it if I had to fly there every week for 3 weeks straight.. LOL.. Its only in 5 spots in the US ? Damn

ONEDAY - Although its not a cure, its a huge step in the right direction... Lets look at this with a positive light , try not to put a damper on spirits.. Although I agree we do have to live while this is in the making.

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thomboy

for me, any news that might improve the condition of life of those infected is very welcome.

* even if not the long awaited cure, it is great to know that will significantly reduce the transmission and still have a reduction in outbreaks.

* many people have mild outbreaks (like me), then virtually "virus not to bother."

* others have more frequent crises, would love to have a big improvement (assuming invez a crisis or two per month, would have one every six months), since it would be fantastic tbm. And remembering that the transmission is virtually nil.

* I assume that I am a very positive person and sometimes that can get me out of reality, but why not believe it will be possible until tests prove the opposite?

* living with that hope, perhaps a way to live well and stand firm to the end.

a hug to all, a great holiday season and a very prosperous New Year for us!!

* "life does not hurt, what hurts is a life that does not live ..."

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lovelyoptimistic

Donnie, i was going to say the exact same thing. Hwerks does not hsve doctors or research specialists who write their articles. It is pretty much a forum like this, and the moderators occasionally write articles. At least this is what i gathered from viewing their site.

There has been no research done with a combine treatment of valtrex and genocea. These are assumptions that they have written.

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Dummy

I dont think any of us can say whats gonna happen... I say stay optimistic and live your life til the day comes when we are receiving a new treatment or cure...None of us are docs .. too much assumption on all the forums.. I pray we're all wrong an things surprise us on a positive note..

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balkans

about gen003,i think genocea can not call it cure,beacuse fda etc.

but i believe gen003 will give permanent suppression of this shity virus.

i don't believe that they are developing vaccine who will got same effect as antivirals.

i expect permanent suppression really.

but they don't wanna talk too much about it.

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Rational Response

Earlier this month, an author on SeekingAlpha wrote about the progress being made on herpes vaccines, which can be found on this cure forum entitled "Promise in Genocea and Agenus", submitted by Oneday; David Knipe said "We are not promising any cures, however, an effective therapeutic vaccine may keep the virus in its latent state, or knock out the virus when it reactivates."

I don't want to speak for everyone on this forum, but if a therapeutic vaccine works like Dr. Knipe says it would, then that will seem like a "cure" in my eyes. I understand what the author is trying to say and he is right, Genocea, at this time, can't label their product, Gen-003, as a cure. He is not implying that it won't be a cure, or that it won't function what Dr Knipe is suggesting, it's still too early to tell. The author knows that and Genocea knows that. Genocea can't make promises that their product will cure herpes before any clinical evidence is made. Gen-003 might cure herpes, or it might produce a strong immune response and keep herpes in check, or it might do nothing at all for us, but we won't know that until the first clinical trials wraps up in the third quarter in 2013. They may use Yale's "pull" method in their next clinical trial. Who knows?

*** It is kind of exciting that the author believes that Gen-003 may be released to the public by late 2016, if all goes well. In my opinion, I believed Agenus would be out by 2017, and Agenus is further along then Genocea; so hopefully Agenus, may be out sooner than I expected.

My thoughts...Agenus would release their progress by 3rd Quarter 2013, like Genocea, but would wrap up their clinical trial as posted in February 2014. They sit on their results and look for a partner who could finance them for the third clinical trial (which may or maynot take some time). They don't go into clinical trials until mid-2015 and that last up to 18 months, which we get the results third quarter 2016 and ends in the forth quarter 2016. FDA takes a few months to review Agenus's clinical trials and HerpV hits the market by second quarter 2017.***

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hellonearth

Someone can just shoot me now!!!!!!!!!!!!!!!!! WHY IS IT TAKING SO LONG TO FIND A FREAKIN CURE? I've had this for three months and if I have to live 3 more years like this just to get a "therapeutic vaccine" then I might as well be a dead woman walking forever! I was cursed, this is pure HELL...I know it can't be that hard to find a cure. I'm not understanding how in 2012 no man/woman on this earth is able to cure this. It pisses me off because I think these companies just want to stay in business and keep us buying these sh!tty embarrassing meds FOREVER. IT'S ALL A CONSPIRACY...I'd do anything to be in one of these "possible cure" studies, I can't live like this.

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fh12

They are all still recruiting. clinicaltrials.gov search genital herpes then click open studies I hope AIC 316 makes it to us much sooner although this is a treatment not a cure. I have not seen anything about a phase three with them yet. They are still recruiting for a second phase 2 for comparison against valtrex.

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Mutant

Its definitely not a cure and that article has a lot of misinformation in it. I think it will be an awesome suppressive vaccine though and I cant wait for it to come out. Hopefully in 5 to 10 years which is the companies projection but they are shooting for the 5.

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Harley1986
Earlier this month, an author on SeekingAlpha wrote about the progress being made on herpes vaccines, which can be found on this cure forum entitled "Promise in Genocea and Agenus", submitted by Oneday; David Knipe said "We are not promising any cures, however, an effective therapeutic vaccine may keep the virus in its latent state, or knock out the virus when it reactivates."

I don't want to speak for everyone on this forum, but if a therapeutic vaccine works like Dr. Knipe says it would, then that will seem like a "cure" in my eyes. I understand what the author is trying to say and he is right, Genocea, at this time, can't label their product, Gen-003, as a cure. He is not implying that it won't be a cure, or that it won't function what Dr Knipe is suggesting, it's still too early to tell. The author knows that and Genocea knows that. Genocea can't make promises that their product will cure herpes before any clinical evidence is made. Gen-003 might cure herpes, or it might produce a strong immune response and keep herpes in check, or it might do nothing at all for us, but we won't know that until the first clinical trials wraps up in the third quarter in 2013. They may use Yale's "pull" method in their next clinical trial. Who knows?

*** It is kind of exciting that the author believes that Gen-003 may be released to the public by late 2016, if all goes well. In my opinion, I believed Agenus would be out by 2017, and Agenus is further along then Genocea; so hopefully Agenus, may be out sooner than I expected.

My thoughts...Agenus would release their progress by 3rd Quarter 2013, like Genocea, but would wrap up their clinical trial as posted in February 2014. They sit on their results and look for a partner who could finance them for the third clinical trial (which may or maynot take some time). They don't go into clinical trials until mid-2015 and that last up to 18 months, which we get the results third quarter 2016 and ends in the forth quarter 2016. FDA takes a few months to review Agenus's clinical trials and HerpV hits the market by second quarter 2017.***

This is the updated information on how Agenus plans to fund Phase 3.

Financing Phase 3

Agenus plans to finance Phase 3 trials of its HSV-2 vaccine with income generated from its other products. The company has 18 products in clinical development, many being developed in collaboration with Glaxo. "We will have a number of companies wanting to partner with us," Armen said.

Privately-held Genocea announced in October that it has raised $30 million in Series C financing. The Bill & Melinda Gates Foundation and CVF, LLC, an affiliate of Henry Crown and Co., are participating with Genocea's existing investors, including Polaris Venture Partners, Lux Capital, SR One, Johnson & Johnson (JNJ) Development Corporation, Skyline Ventures, Cycad Group, Auriga Partners, MP Healthcare Ventures and Morningside. Genocea has raised a total of $76 million in equity financing to date.

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thomboy

well if it occurred in the second trial, I would be in an apportionment to fund phase 3.

I do not know how much it would cost but yes this would be money very well spent.

* but I think if all goes well, they will not lack partners for the next step.

* I hope it's fast ...

optimal one night, and good luck to us!

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      Thanks for your story.  It seems similar to mine. Fortunately for you it seems your boyfriend is willing to pursue some kind of understanding. Since I wrote about what happened to me, my boyfriend broke up with me. The ironic thing is he told me this happened to him about 15 years ago with another woman. He said it was very traumatic for him and felt like the same thing once again. So it seems he had been exposed before and could very possibly have already been carrying the virus. Perhaps he knew and didn't tell me. I am really not sure but the relationship is over for now since he won't discuss it with me. So much fear information and confusion out there about the virus. I don't think they really understand how it happens so they tell everyone to be careful. Even having the virus it has been such a non-issue in my life until now that it appears there is so much stigma around it. It seems more like it is the Pharmaceutical companies wanting to make money off a common virus that affects so many on such a deep level, receiving love and physical contact.  Feels like a big scam to me.  The information was so different when there were no drugs to reduce or suppress the virus. It is all very confusing to me.
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    • raka
      I contacted one of the ayurveda doctor in india he is saying there is 60% chances of cure through ayurveda for herpes Details: Please see the treatment details mentioned below
      Treatment Duration: 12 months - 18 months - 24 months.
       
      Generally majority of young patients with not a long history of infection gets cured in initial 12 months, but there are possibilities that the cure might need a total of 2 year’s medication too.
       
      Therefore you can start with first 6 months of medication and depending upon the results and prognosis further medication can be ordered later. 
       
      Initial results of our medication will be felt after completion of 90 days to 120 days and generally the symptoms don’t occur after 120 days or sometimes even if the symptoms re-occurs it will be mild and will disappear shortly,
       
      Please understand that, we are not treating the symptoms but the virus, therefore till the virus is alive inside the body any time symptoms can occur, but majority of cases what we have seen is after the 120 days completion of medication symptoms seldom occurs and even if the symptoms occurs it will be very mild and will go away faster, so dont worry even if you get any symptoms during the course of medication. 
      Our aim is to cure the virus and not the symptoms, symptoms is just associated with the virus activity and after the 120 days medication the viral activity will be reduced and not fully stopped and that’s why you can get symptoms during the treatment, but this viral activity will be weak, and that’s why symptoms will be milder and will go away faster.  As the treatment progresses then the viral activity will further reduce and ultimately the virus will be dead. 
       
      About Medication: Medication will be in the tablet format which will be of 4 different variety to be taken after food. Generally non vegetarian food has to be reduced to the maximum while on treatment. Consume more of vegetarian food only for better and fast results.
        For your information, the names of our medicines with ingredient details are given below, you have to take the below mentioned combination of 4 medicine in tablet form.
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      Batch No: 259
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      Haritaki – Chebulic Myrobalan (fruit rind) – Terminalia chebula
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      Vibhitaki – Belliric Myrobalan – Terminalia bellirica
      Shunti – Ginger (rhizome) – Zingiber officinalis
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      Ardraka – Ginger (rhizome) – Zingiber officinalis
       
      3) Tablet KG GULFORTE
      Batch No: 260
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      Commiphora mukul
      Terminalia chebula
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      Emblica officinalis
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      Batch No: 261
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       Vidari – Pueraria tuberosa
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      Pippali – Long pepper fruit – Piper longum
      Haritaki – Chebulic Myrobalan fruit rind – Terminalia chebula
      Vibhitaki – Belliric Myrobalan fruit rind – Terminalia bellirica
      Amalaki – Indian gooseberry fruit – Emblica officinalis Gaertn.
      Loha Bhasma – Bhasma prepared from Iron
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      Vida Lavana – Vida salt
      Samudra Lavana – Common salt
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      Sauvarchala Lavana – Sochal salt
      Romaka Lavana
      Chavya – Java Long Pepper – Piper chaba
      Pippalimoola – Long pepper root – Piper longum
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      Danti – Baliospermum montanum
      Shati – Curcuma zeodaria / Hedychium spicatum
      Water decoction of Haritaki – Chebulic Myrobalan fruit rind – Terminalia chebula
       Treatment Cost:
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