Genocea Herpes Vaccine Has Completed Phase One Trials With Great Success.
Genocea Herpes Vaccine GEN-003 Results.
Genocea has just completed their phase 1/2a clinical
trial in the search in finding a functional cure for Genital Herpes. The
results do seem to be very promising and Genocea is planning on starting phase
2 trials in 2014. There were 143 participants in this trial who all had a history of moderate to severe cases of Genital Herpes Simplex 2 (HSV2) . The trial did not include subjects with HSV1 (Herpes Simplex 1).
The results of Genocea GEN-003 Therapeutic Herpes Vaccine indicated a remarkable reduction in viral shedding by 51%. This would drastically reduce the risk of transmitting the Herpes Simplex Virus on to potential sexual partners.
How does the Genocea Herpes Vaccine GEN-003 Work?
It works by activating the T Cells in the host so that they are better equipped to fight off flare ups of the Herpes Virus. So basically training the T Cells to quickly identify and destroy a Herpes infection before it makes it to the surface. As the body has been programmed to receiving an attack, your immune system kicks into gear a lot quicker to fight off the Herpes Virus.
How was the GEN-003 Vaccine administrated?
Genoceas Herpes vaccine is administered in a series of 3 injections. Booster shots every few months or so would be needed to keep the vaccine active. As it is a Therapeutic vaccine it is not a cure for Herpes as the host will still have the Herpes Virus in their Nerve cells. The Therapeutic vaccine works by programming the hosts immune system to better fend off the Herpes Virus. This could be the makings of a functional cure.
What is a Functional Cure for Herpes simplex viruses?
A Functional cure means that the host is no longer contagious and can be considered as close to a Herpes Cure as possible. In this clinical trial Genocea concentrated on Herpes Shedding and not in determining if it reduced the amount of outbreaks of the infected hosts. They did however notice that periods between outbreaks did increase, which is very good news. It could be a great alternative to oral treatments such as Valtrex or Acyclovir. Though according to the study, you can take oral antivirals at the same time as the vaccine,hypothetically reducing even further the risks.
When is Genocea Herpes Vaccine entering phase 2 clinical trials?
In 2014 Genocea will enter phase 2 trials. The aim of these trials would be to experiment with different dosages of the GEN-003 Herpes Vaccine as well as to see if the period between Herpes Outbreaks can be extended or even eliminated. The experimentation with the dosages would also show if the vaccine could do better than the current 51% reduction in Viral Shedding. Most drugs sadly fail during this phase of clinical trials as this is when the results are strictly analyzed for effectiveness and safety. The FDA is also going to look to see if this new product is better than current products on the market. In Genoceas defense, they do seem to be the first company who has had such amazing results in the vaccination area.
Genocea is under the obligation to follow the FDA
approval system for new Drugs.
Phase 1 studies are usually conducted in healthy
volunteers. The goal here is to determine what the drug's most frequent side
effects are and, often, how the drug is metabolized and excreted. The number of
subjects typically ranges from 20 to 80. (Duration 1 Year)
Phase 2 studies begin if Phase 1 studies don't reveal
unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis
in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on
whether the drug works in people who have a certain disease or condition. For
controlled trials, patients receiving the drug are compared with similar
patients receiving a different treatment--usually an inactive substance
(placebo), or a different drug. Safety continues to be evaluated, and short-term
side effects are studied. Typically, the number of subjects in Phase 2 studies
ranges from a few dozen to about 300. (Duration 2 Years)
At the end of Phase 2, the FDA and sponsors try to come to an agreement
on how large-scale studies in Phase 3 should be done. How often the FDA meets
with a sponsor varies, but this is one of two most common meeting points prior
to submission of a new drug application. The other most common time is
pre-NDA--right before a new drug application is submitted.
Phase 3 studies begin if evidence of effectiveness is shown in Phase 2.
These studies gather more information about safety and effectiveness, studying
different populations and different dosages and using the drug in combination
with other drugs. The number of subjects usually ranges from several hundred to
about 3,000 people. (Duration 3 Years)
Application review and licence request for the new Drug.
New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. (Duration 1 Year)
When will the Genocea Herpes Vaccine be available on the market?
If we follow the FDA guidlines, we could assume, if Genocea passes all of the clinical trials, that we could have this new Herpes Vaccine on the market around 2020 - 2021. Genocea still has a long road to travel, but the whole management team at Genocea seem very excited and confident in their product. There may be a possibility that Genocea is fast tracked through the system if they can prove they are offering a revolutionary new Herpes drug.
Questions about Genocea Herpes Vaccine.
Chip Clark, President and Chief Executive Officer of Genocea kindly
answered some questions that were put to him by the Herpes Community.
Q. Dear Mr Clark, the current clinical trial are being held in America, is there any chance that for phase 2 clinical trials could be held in different countries?
A. We likely will go ex-US at some point, but have not decided for the next trial.
Q. Mr Clark Phase 2 is in 2014 (2 years duration) If passes phase 2, we will enter phase 3 around 2016. (3 years duration) and finally the drug license application around 2019 (1-2 years duration) So if all goes well (fingers crossed) release date 2020 -2021 That sound about right?
A. Yes, about right as a guess. I just do not want people thinking we were a couple years from approval because of good data. It takes time.
Q. For how long would the vaccine be effective and how often would we need to have booster shots?
We don't know durability of response. It's 3 jabs, then a booster could
be every 3, 6 or more months. We're still monitoring enrolees to get insights
So with all this exciting developments in the Herpes Vaccine and Cure
research, we can definitely say that we are edging closer towards a cure against
the Herpes Simplex Virus. The Herpes Cure might not be here tomorrow, but it is
certainly on the horizon.
For more information on Genocea you can visit their web page.
For their latest press release on the GEN-003 Vaccine, you can find it here.
For news on Herpes clinical trials in your area, you can find it here.
Also remember that there is a Secret Facebook Group where a lot of community members discuss and share information about Herpes Cure
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