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oneday

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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frank80

Good news so far

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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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