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Herpes Cure Research, Potential Vaccines, Genocea Biosciences
Date 2013-10-04 | Views  4613

Herpes Cure Research or Potential Vaccines, what is being done?


In truth, quite a bit. However, cure research is not a one-step process. Even when a potential cure or vaccine has been developed, it still takes years of testing to make sure that it is safe for humans.

The FDA timeline for approving drugs is a lengthy process. The steps are more or less as follows:

Phase 1- Consist of 20 - 80 Healthy Volunteers, to establish a drugs safety and profile. Estimated timeline of 1 year.

Phase 2- Employ 100-300 Patient Volunteers, to assess the drugs effectiveness. Estimated timeline of 2 years.

Phase 3- Involves 1,000-3,000 Patients in clinics and hospitals, which are monitored carefully to determine effectiveness, identify reactions and/or side effects. Estimated timeline of 3 years.

The Company then submits an application usually in excess of 100,000+ pages, to the FDA for approval. A process that can take up to an additional 2 and a half years after the clinical trials. After the final approval, the drug then becomes available for Physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.

In the best case scenario, if the tests are a success, a new medication could be on the market within 8 years after the starting trials of Phase 1.

Now that we understand the procedure on how the FDA Timeline is constructed, we want to introduce to you a very promising vaccine for Herpes, developed by the company Genocea Biosciences.

Genocea Biosciences is developing both Therapeutic and Prophylactic Vaccines for HSV2, based on the discovery and validation of antigens with our ATLAS platform.

Our lead candidate in HSV-2 is GEN-003. A first class, protein subunit, therapeutic T cell vaccine. Designed to reduce the duration and severity of clinical symptoms associated with moderate, to severe HSV-2. Also, to control transmission of the infection. A Phase 1/2A clinical trial is currently underway to evaluate the safety and tolerability of GEN-003. The study will also conclude an assessment of the vaccines impact on Viral Shedding, the process by with the virus can spread to people when no signs or symptoms of an outbreak are present.

Unlike previous HSV-2 vaccine candidates, GEN-003 is a Protein Subunit vaccine. Designed to mount responses from both the T and B cell arms of the immune system, which is believed to be critical to achieving long-term control of this chronic infection. GEN-003 includes the antigens ICP4 and gD2, along with the adjuvant Matrix-M licensed from Isconova AB. The adjuvant is a novel, saponin-derived product that has demonstrated a balanced T and B cell immunostimulatory profile.

In preclinical Proof of Concepts studies, these antigens demonstrated protection against disease. Also, reduced the duration and severity of clinical symptoms and viral shedding. Genocea Biosciences presented data from these studies in 2012 at the American Association of Immunologist annual meeting and International Herpes Virus Workshop.

If approved, GEN-003 will be the first therapeutic vaccine to address an infectious disease. For more information on our clinical trial, please see http://clinicaltrials.gov/ct2/results?term=gen-003.

Frequently Asked Questions

A few people asked Genocea Biosciences some very important questions, which a spokesperson of Genocea Biosciences happily replied to.

Q: Is there any research focused on shedding with Genocea?

A: Genocea and many others, recognize that shedding is as big of an issue as the visual symptoms of HSV-2. Therefore to be called a success, our programs need to show an effect on shedding. We are evaluating that in our current clinical trial. I know that others are as well.

Q: How does one get involved in the clinical trials with Genocea?

A:Please see our listing at clinicaltrials.gov: http://clinicaltrials.gov/ct2/results?term=gen-003

Q: How far are we? Considering that Trials go successfully, from a product like GEN-003 being available to us?

A: We have some ways to go for an FDA-approved product. I wish I could say it was close, because I appreciate what you are going through. For everyone's info, here are the basic stages of drug or vaccine development (and time required):
-Basic research: 2-10+ years
-Preclinical testing (showing that it does in animals what you want it to do in humans): 2-3 years
-Phase 1 (human safety): 1-2 years
-Phase 2 (human safety and preliminary efficacy): 2-4 years
-Phase 3 (large scale human efficacy testing): 2-4 years
-FDA review: ~1 year.


So, Genocea Biosciences and our GEN-003 vaccine could be as few as 5 years(since we're in Phase 1/2) and potentially many more years away, depending on our results.

Q: If the phase 1/2 goes really well, is there a chance GEN-003 could be fast tracked?

A: I can appreciate why you'd ask this. The current Fast Track program emphasizes getting new therapies that treat life threatening illnesses to the market fast. HSV-2 would not qualify, terrible though it may be. Also, typically the FDA would want to see more than just 150 patients worth of data. Which is what we'd have after this trial. To my knowledge, there's not a hard-and-fast rule on this. So I would say that the likelihood is very low that it could happen after this trial. But if we have very promising data emerge, the agency could help us identify a streamlined path to approvalthat might shorten the timeline

Q: Do you expect it to work on HSV-1 as well?

A: We don't know if it will work in HSV-1. The viruses are, structurally, quite similar so there's reason to believe it may. That is not the focus of our current trial though.

Q: Is Genoceas approach considered a cure? What exactly does this vaccine hope to accomplish?

A: We won't know until we see data from our clinical trials. Because HSV-2 is a virus, and because it basically hides within nerve cells, it's hard to think that we can eradicate the virus. But in some way we may be able to either keep the virus in a latent state or increase the immune response to the virus if it emerges from latency. If we can do that we might be able to reduce both symptoms and shedding.

Q: In your view, why is that it took so long, I mean decades, between the advent of antivirals like Zovirax and Valtrex, for a novel approach like Genocea's DNA vaccines to just now been trialed ? It seems that HSV is almost a world epidemic and we are still taking pills from the 80's to treat symptoms, plus for many people out there these antivirals are plain ineffective.

A: A great question. It's one I didn't know the answer to until I joined Genocea a few years ago. Let me explain it in the way I do to potential investors. Apologies to scientists on this thread: I will probably over-simplify.
Basically, science has approached vaccine development in the same way for more than a century. We introduced either an inactivated pathogen or some piece of it (a protein) to our immune system and measured protection by B cell response (or antibody response). This has worked extremely well for many infectious diseases, ranging from polio to mumps to HPV. What these infections have in common is that they can be intercepted in the bloodstream which, to oversimplify, is where the B cell arm of the immune system does its work.
Many pathogens elude the B cell arm of the immune system by hiding within cells (eg Chlamydia, HSV) or within our mucosa (Staph aureus, etc.). It has come to be understood only comparatively recently that the way our immune system fights such pathogens is through the T cell arm of the immune system.
We have not been able to try to develop vaccines against these pathogens because we haven't known how to target the immune system or enhance our T cell immune response. We (and many others) have theories about how to do this, and we are developing vaccines to validate those theories.
So, the reason for no vaccine to date has more to do with huge technical challenges than with a lack of understanding about the need. BELIEVE ME, I have never had to convince an investor of the need.

Q: When do you expect Phase I trials to end with GEN-003 and when could we likely start seeing some results or papers published again on the progress of how the trials are going from the Phase 1 /2a study? Or is it likely to not see anything new for a while because of secrecy? And if secret, how long do you guess before we know for sure that the vaccine is successful? And I am right when I say that the vaccine most likely will only be successful with the Matrix M-2 adjuvant? And that this is partly why the GlaxoSmithKline vaccine failed, was because of its failure to use a similar adjuvant?

A: We should have results late next year, and we intend to share them virtually as soon as we have them.
Matrix M is different than the GSK adjuvant, but so is one of the vaccine proteins. If the vaccine is a success, then one or both of these differences will have enabled the success. We may or may not be able to ascribe it to one or the other.

Q: Do you have any idea what the cost of the vaccine would be provided it works and goes to market?Are you able to give us an estimate at this time?

A: We have no idea about the price. We have a lot more to learn about the vaccine before we think about it.There is hope that the cost of the vaccine would also be an advantage over current antiviral treatment.


UPDATE: Genocea have completed their phase 1/2 trials. You can read about their results over here. It does look very promising.

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