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

December 3, 2012

in Herpes Cure and Research

GEN-003-trials

GEN-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!

 

{ 28 comments… read them below or add one }

Rad December 3, 2012 at 7:52 pm

Thanks for the update!!
I see it will just be a treatment!! Mainly
Suppresive like other antivirals on the market!

Maybe its not called Cure cause FDA will be more
Aggresive on asking for more results and could damage
this study and its potential to help!!
So 2016, its not that far, but i think this could take more than
5 years.
And how are the updates about people that had this clinical trial??
Are people reacting well??
Are they having reurrence??
Thanks Dex.

Dex December 3, 2012 at 8:26 pm

Hi Rad!
Yes, they couldn’t go to the FDA claiming a “Cure.” The 2016 date is a very optimistic estimate. Lisa hasn’t reported any recurrence but that will differ from person to person. People that were on suppressive therapy will have to get off of it for 7 days before the trial and for the 59 week duration. So, they may have a higher recurrence in the beginning. She did say that her swabs were showing up negative but those are just taken from the private parts. We are going to try and get her into our chat for a Q&A session as the trials progress.

Rad December 4, 2012 at 5:33 am

Thanks Dex,
So far so good, it will be very good to have her in chat!!
How long has she been on those 59weeks??
When does this phase 1 and 2 finish??? If its already started, they must have a timeline??
Do they have any other updates of the other patients in trial?
Thnxs Dex

Rad December 4, 2012 at 5:36 am

Dex, when you say swab, you mean they are testing her to see if she has the virus or not???

Rad December 4, 2012 at 5:59 am

An interesting fact, is that in todays studies about Herpes, the Hsv1 Genital is much more common than the others.
Thats a fact in all over the world, why Genocea is focus on one type only?? Why they are not studying the effect on the Type 1?
If its a very identical virus, why dont they grab clinical patients to test this with type one also?
Regards

meka December 4, 2012 at 5:33 pm

So you people telling me that there will never be a actually cure for herpes????

fight hsv December 9, 2012 at 4:44 pm

I am also wondering why they are not studying hsv1 as well. I have genital hsv 1 and does this mean if all goes well for gen003 it will only be for people with hsv2? please clarify

meka December 9, 2012 at 8:13 pm

@fight hsv. I have told hsv2 is more severe than hsv1. Because only cold sores and fever blisters on the lip. People with hsv1 has less outbreaks the people with hsv2. People with Genital herpes have it worst. It hurts to urine, bathe, walk, sit, and the list goes n etc. Yes, Hsv2 is more serious

Rad December 10, 2012 at 9:39 am

@fight hsv and @meka

@ Fight – Genocea vaccine MAY work against HSV1 but they don’t know yet. In fact, the viruses are almost identical under a microscope, so it may be possible. They do intend to study the vaccine in HSV1. If the trials are positive, they may start a trial for Hsv1. So hope is still there; like the antivirals, they were tested for Hsv2, and they have a very positive impact on Hsv1 also, so there still hope. We only have to pray the trial goes well and positive results are giving at the end.

@ Meka, i think you are not understanding well, Hsv1 could also be transmitted on genitals, this being the same as GENITAL HERPES (Hsv1 or Hsv2).
Same symptoms are in genitals with Hsv1 (Burning when urine, to walk to sit, etc.etc.), the only advantage is that is not on its preferred location; and the outbreaks are less severe, and recurrence are much less than Hsv2. That said the shedding on the virus is less, meaning that the transmission rate for the Hsv1 genital is less than Hsv2.
But in conclusion Genital Herpes could be Hsv1 or Hsv2. So in other words they are both serious; but manageable.

Keep the faith!
Best Wishes

Matt December 23, 2012 at 4:45 am

Actually I think they know of a cure know and may have it tested already. The true test is will they release it to the public. There is a LOT of money in treating Herpes vs curing it. If you are a corporate big wig at a drug company that makes an antiviral do you want the need for your drug to disappear/significantly reduced in the matter of a few years?

The potential cures that “I” think have already been privately demonstrated are:

1. A synthetic microRNA is administered to the infected perstion. This microRNA prevents the Latent HSV from producing a special proteine that keeps the virus latent. Essentially this little bugger acts as a lookout. When a person/animal is stressed (heat stroke, hypothermia, other infection, etc.) The production of this special proteine decreases. This signals the virus to begins replication. Eventually a one or two pieces of viral code migrate from the nerve to the outer layers of skin and begin active replication. You then get a cold sore and start shedding lots of virus to infects others. Eventually your body’s immune system kicks in and destroys these active virus. The kicker is that most of the HSV stay latent in your nerve cells.

The synthetic microRNA will bind with the “latency inducing” protein and neutralize it. It essentially will force all of the latent virus to come out of dormancy. An anti-viral drug can then be used to kill all of the virus in your system since it all will have been forced into active replication. In essence you get one more cold sore and then are cured for life. You will have natural immunity for the remainder of your life.

At least that is how the theory goes. My guess is they have tried this already in animals and it works. It would be a true cure.

2. A “vaccine” that would in essence provide a cure over time to the host who receives the vaccine. The vaccine works by causing th body’s immune system to recognize proteins that HSV codes for to initiate reactivation and duplication. The body would SEE the virus at a much earlier stage and prevent it from replicating. This means that viral particles that would normally migrate to the surface of the skin and cause a lesion, would be recognized and destroyed by the bodies immune system before they could cause a lesion.

The host would still be infected by latent HSV residing in the nerves. The goal is to prevent shedding and transmission of the virus. The upside is the host has no more symptoms and with good vaccination rates, over time the virus would be eliminated from the general population, much like Polio.

I have HSV-1. I get a cold sore ONLY after infection with something else. Common cold, flu, etc. about the time I am getting over the normal cold the HSV-1 emerges and I have a freaking cold sore on my lip again.

My personal preference would be option 1. I want to kill the freaking virus dead. Once that is done I would then get the vaccine as added protection against re-infection.

I think the next 10-30 years is going to see a LOT of knowledge gained on how virus’ work along with novel ways of defeating.

On the alternative medicine front Zinc Ions also seem to have a very stong anti-viral effect against HSV virus. This though is no surprise and has been know for almost five decades now. The downside is that it requires daily application of a zinc ion solution to the areas that are known to contain HSV infections. Do a search on pub med and you will find some research into this that looks promising. It is not a cure, but a cheap way of reducing/eliminating the dermal infections.

With the recent findings of HSV DNA in almost all Alzheimers plaques, I REALLY want to see a cure and then an eradication of this virus. I, personally, would pay $500 to $1000 of hard cash for a true cure. It is worth that much to me to be free of these damn cold sores.

Mikey December 24, 2012 at 8:03 am

Ill pay 10k or more CASH… For this cure.
But its something that will NOT see in many years to come, and many scams are out there, so people have to stay away of all those scam artists.

meka December 25, 2012 at 10:42 am

@Matt i agree these ppl are full of it. ppl are getting it n don’t deserve to have it but it happens. i hope God bless us all soon because it doesn’t have to be this way. I will see just how much long it takes for them to release a cure. Its been roughly 40yrs of more and they still saying no cure is available a lie don’t care who tell it. The ones saying it don’t have the dam virus

Curenowplz December 27, 2012 at 4:23 pm

Hsv1 cure should be found easily..i think they both have a cure that they wint release which.is unfair. Ive seen articles that cures it because its a virus that hides. It attacks it when not hidden and kills it. Have been proven to work so I dont see why they dont use that to cure hepres and us the people. I just want answers and a cure

david January 8, 2013 at 8:43 pm

Why can’t they just include poeple with genital hsv1 in this study to see if it works?

Rad January 9, 2013 at 7:24 am

Hi David
Genocea vaccine MAY work against HSV1 but they don’t know yet. In fact, the viruses are almost identical under a microscope, so it may be possible. They do intend to study the vaccine in HSV1. If the trials are positive, they may start a trial for Hsv1. So hope is still there; like the antivirals, they were tested for Hsv2, and they have a very positive impact on Hsv1 also, so there still hope. We only have to pray the trial goes well and positive results are giving at the end.
Why dont include people with type 1 genital??
Cause its very difficult to see results, cause it shedds so infrequently, just like all studies of the antivirals, they did it with type 2, caise it has more episodes of shedfing, leaving more trend and data to analyze..
And antivirals are working well with type 1 also!!
So theres a chance if this vaccine works for type 2, it will work for type 1..
We have to wait this results and them the will make a trial for type 1 if it had a good outcome!!
I know its hard to wait!! But its part of this extensive study!
Take Care

futureforward1 January 9, 2013 at 6:23 pm

I have read that these herbs offer a natural vaccine or cure:
galangal, lapacho, astragalus, cat’s claw, myrrh, ligustrum, pansy are all supposed to be antivirals
Thyme, licorice, cayenne fight the virus
Reishi-mushroom boosts immunity and is antiviral
Lysine-amino acid helps with prevention
Echinacea, vitamin c, and zinc help build immunity
How much of this, if any, is true?
I found out my results about a year ago-at age 44- through a random exam by my doctor. I was totally devastated. I had never had any outbreaks or problems before and none up to this day. I have met a wonderful person whom I’ve seen for 8 months. I was honest with him about my situation, and even though I take Valtrex as a suppressant, he is scared to death to touch me. I’m so afraid that I will grow old and be alone. I, too, would pay good money for a real cure.

Pretty_Princess1 January 20, 2013 at 9:03 am

I would be interested in knowing the results of ‘Lisa’s’ swabs. Another participant that shared her experience in the trial indicated that they did not share that information with her. Everything else is the same though, she feels fantastic, no OB, and it was like before she became infected. I think this awesome and add to it negative swabs in everyone vaccinated, which I take to mean no transmission risk, to me this is a cure under another name.

One question I have is given Lisa’s experience and the other poster’s what would be the need for the valtrex on top of this (assuming negative swabs)? I understand you broke it down up there but that was under the assumption of only 75% efficacy. Given the experiences I have heard it sounds higher. Somewhere in the high 90s.

As a side note I spoke (well emailed back and forth rather) with one of the study sites trying to participate but I lived too far and the deadline was fast approaching so I could not participate. Although she did share with me that it was “likely this study will continue on to the next phase ” (I guess based on past data and experiences) and it would be open in many more cities with many more participants and I could participate then. Which I guess is better because everyone in that one will receive a theraputic dose of 100 mcg rather than a sub-theraputic dose and/or a placebo.

Kim January 21, 2013 at 11:54 pm

I am so glad I came across this page. I found out that I was infected about 5 years ago and to my knowledge I havent had an outbreak until now. I must say it has been the worst time of my life it seems. If anyone has any suggestions as to how to cut down the time of the outbreak please let me know. Also I have children anything that I may need to know? I feel as though I should lock myself in my room to Protect my kids and my dog.

Jarlath Healy January 22, 2013 at 12:37 am

They just found the cure for Hep C (2012) that has no side effects but Gilead INC is not wanting to share its knowledge with a similar company that has the second piece to the puzzle. So, look at the Herpes cure like that. 2016, then hopefully shareholders aren’t making the decisions. Proven HIV cures stuck in clinical trials, Hep C cure fighting with shareholders, Herpes cure indecisive/inconclusive, DRACO universal anti-viral taking forever to test in humans. Its like these people are seriously trying AS HARD AS THEY POSSIBLY CAN to squeeze the last cash out of a disappearing market.

Rad January 22, 2013 at 7:16 am

Hi Kim,
If you’re having so much trouble with this, it must be genital outbreak!
Well my dear, if you have it since 5 years ago, and this is your first outbreak, maybe next one will be 5 years later or there may never be another outbreak.
This happens often with Genital Type 1, as it tends to shed less and its outbreaks are so infrequently.

The best thing to cut down the Outbreak, is definitely Antivirals (Valtrex, Zovirax or Famvir), this meds come on their generics brands that work great also and cheaper.
This is truly the best way to cut down the time, yes many ways to keep them dry and help them to heal, supplements like Zinc and Lysine, but a good dose of Antivirals for Outbreaks is going to be like a magic pill believe me!

In terms of being scared of your children, your worries are normal sweety, but don’t worry to much, this type of virus, don’t live much out on the open. That’s why it’s almost impossible to get this at a public place or something like that.
So you just got to the bathroom like you usually do, take your bath, apply your antiviral cream, clean your hands well and you’re good to go.

This is a skin to skin contact virus, so if you have it genitally, your kids or doggy will not be down there for sure..

If it was cold sore on mouth, well its avoiding contact kissing or touching your mouth and touching them as soon as you touch the blister.

Just be clean, your doing great protecting your kids and continue your life normal.

This is just a skin condition, that’s all, I know it could be hard at first, mostly emotionally, but its something very common and something you can live normal for the rest of your life!

I hope you can continue your life with your kids and pets and be happy for the rest of you life!

Take Care and Good luck!!

Kim January 22, 2013 at 6:31 pm

Thanks a million for the encouraging words. I have 3 on my arms I think. Is it because of something I have done…I have been told all my life that I have OCD because of how clean I am so what more can and should I do.

Rad January 22, 2013 at 7:38 pm

Hi Kim,
You have 3 blisters on your arm??
If so have you been tested?? Important to Test those blisters
By swab!!
This will let you know, if you have it or not.

I dont have much information about your symptoms, so its
Hard to tell you!!

Hope you are better!
Take Care

Love January 22, 2013 at 10:02 pm

Will this be something a person would take once for the three intervals in a lifetime or yearly, every 5 years….?

Dex January 22, 2013 at 10:06 pm

@Love
I do not know if it is a one time deal or if you will need a booster. It would be great if it was like the Polio vaccine shot. Like herpes, Polio is a virus but you get the vaccine as a kid to protect you from getting it.

kryssy January 24, 2013 at 7:16 pm

Are there any negative side effects that you know of ? Do you have to live in the same state to participate in this particular study?

Thanks!

Kim January 24, 2013 at 8:49 pm

Rad, thanks for all the input I went to the doctor today and thankfully It wasn’t an outbreak. I recently got over a cold which caused this to happen. I must say its definitely an eye opener I will definitely continue to pray for the day when the cure can be available to us all.

yme January 27, 2013 at 1:59 pm

i pray they get a CURE SOON i got it from a person who thinks its funny to give someone the horrible virus i just turned 22 always wantd to have kids and have a healthy family but thats something i can do now. i feel like an alien like i am different from everyone else dont even like coming around my family scared i mit give them this virus i pray they find a cure soon to heal all of us i have to have faith

Rad January 27, 2013 at 6:31 pm

Hi yme,
Its sad to hear that kind of atittude from tbat person.
Well let me tell you something, i dont know much about your particular diagnosis, cause you dont say
If its oral or genital; well let me thinks its genital, as you are having so much trouble dealing with this..
Ok, first of all YOU CAN havr a healthy family and kids even with genital Hsv 1 or 2.
So thats out of the question!! Second i know how you feel we you say you feel like an alien and feel strange with family! But its almost 0 chances to infect your family as its genital!
If its oral, well just avoid kissing and sharing cups for the time of the outbreak.

My friend, this is very common, please relax!!
Its like a cold or flu, comes an goes!! It wont kill you!!
Just a skin condition!!
Cure or not, you will be fine, I PROMISE!!!

If you have any questions regarding transmissions or type of H or just need to vent dont hesitate on writing again!!
Best of Luck!! And I know you will be alright!!

Go ahead and leave a comment! It's painless and kinda fun!

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