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Is a herpes treatment close? GEN-003 in Phase 2

Gen-003 heres treatment

Could a effective herpes treatment be close? Genocea’s GEN-003 entered Phase 2 in 2015

While a herpes cure may be a long way off, a herpes treatment may be getting closer.  A little over 2 years ago, we wrote about Genocea’s GEN-003 therapeutic vaccination. The good news is the study is still going on and Genocea has updated their website with some promising information.

First and foremost, Genocea’s GEN-003 is NOT a cure for herpes.  Instead, they are working on a herpes treatment for the symptoms of the genital herpes (HSV2) virus and the reduction of the spread of herpes through viral shedding.

Genocea:  GEN-003 is a first-in-class T cell-directed immunotherapy intended to reduce the transmission risk and clinical symptoms of genital herpes.

On Oct. 8, 2014, Genocea issued a press release stating that their Phase 1/2a clinical trial has been completed:

After 12 months, GEN-003 shows durable reduction in genital lesions

The Phase 1/2a clinical trial was a double-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of GEN-003. In addition, the study was designed to demonstrate proof-of-concept that GEN-003 can reduce HSV-2 viral shedding, a measure of viral activity, and the genital lesion rate, the percentage of days during which the subjects experienced visible herpes outbreaks or lesions. Current HSV-2 therapies only partially control clinical symptoms and viral shedding, which drives disease transmission.

During a 28 day observation period 6 months after GEN-003 dosing, subjects who received 30 microgram doses of GEN-003 had a 65% reduction in genital lesion rates compared to baseline (p < 0.001). In addition, during that same period, those subjects experienced a 40% reduction in viral shedding compared to baseline (p < 0.001). Twelve months after the final dose, the mean reduction in the genital lesion rate was 42 percent below baseline for this dose group. Immune responses to the treatment, including T cell, IgG, and neutralizing antibody, remained significantly above baseline at the end of the 12 month follow up.

The study enrolled 143 subjects with a history of moderate-to-severe recurrent HSV-2 infection at seven clinics in the United States.

The researchers also went on to mention that GEN-003 did not have any serious side effects.  The most common were fatigue, muscle aches, tenderness and pain, with the majority being mild or moderate in intensity.  During this study, July 2014, Genocea initiated a Phase 2 study to confirm the efficacy of dose and dose combinations.

Fast forward to Jan. 7, 2015.  Genocea enrolled over 300 people from 17 locations around the US for their Phase 2 dose optimization study for GEN-003.  From their press release:

“The objective of this trial is to build upon the impressive results observed in the prior Phase 1/2a trial. Our goal is to replicate the results of the best performing vaccine dose in that trial, and test other combinations of proteins and adjuvant. By achieving these objectives we will identify and fully justify the best dose to take forward based on an optimal balance of safety and anti-viral activity”, said Seth Hetherington, Chief Medical Officer of Genocea. “The patient response and rapid enrollment we experienced underscore the unmet medical need for new treatment options with novel mechanisms of action for this lifelong disease.”

Researchers will continue to follow the Phase 2 participants for another 12 months after the study.  They hope to post results late in the second quarter of this year (2015).

While not a cure, the GEN-003 herpes treatment could bring relief to millions of people who suffer from the painful symptoms of herpes by reducing the number of outbreaks.  It could also lead to different ways suppression therapy is administered by reducing the number of doses required.

Why is this hopeful, you ask?  Well, if a herpes treatment could stop the symptoms and prevent the spread of herpes, then the battle would be won.  Whether or not this may be a reality or a pipe dream, is still up in the air.  It is refreshing to know that researchers are working on this and have not given up,  like so many others have in the past.

Currently, there is not a cure for herpes.  GEN-003 looks promising but it could take years to reach the market, if it does at all.  Even then, the effectiveness for the masses has still yet to be determined.

Whatever you do, please do not put your life on hold waiting for a cure or even this herpes treatment.  Go out and live your life the way you were meant to live it!

6 comments… add one
  • K

    May 10, 2015, 8:35 am

    Is hwerks active? It seems like they revamped it, then added some blog posts after a gap…. Is hwerks an active social site? ~K

  • Dex

    May 10, 2015, 5:53 pm

    Hello K!

    Yes, we are still a very active social and dating site! We will be posting some more blogs shortly.

  • Aaron

    July 29, 2015, 3:21 am

    A vaccination alone would be great. A person carring the virus doesn’t need to be cured if you can vaccinate their partner and prevent them from spreading it. I can imagine “the talk” would be a lot easier if you said “oh by the way, you can vaccinated and then I’ll never pass it on to you.”

  • Nima

    August 26, 2015, 1:50 pm

    Why don’t they just make a pill that causes the virus to be visible and causes outbreaks, a lot, then it would be a lot easier to remove it and cure it with medicine….?

  • 110Voltage

    December 7, 2015, 7:23 pm

    Maybe they’re barking up the wrong tree with this approach. The virus is virulent, and persistent, and seems to show a “preference” for being around highly sensitive nerve groups, this is just wild speculation, but maybe it likes the electrical impulses traveling through those areas particularly. Perhaps they have a vulnerability to electrical impulses of given frequencies or voltage, which would either deactivate them or “kill” them (yes we all know science says viruses aren’t alive, I don’t think anyone cares about that point). As we know from we larger “biological machines”, the right application of electricity can cause us all kinds of grief, maybe something could be applied to this nasty bug that won’t hurt us due to our size, but will be devastating, or perhaps even lethal, to it? Just a thought.

  • John

    June 17, 2017, 12:17 pm

    Phase 2b is progressing nicely and they are discussing phase 3 by the end of the year. Judging by their press releases, this treatment is their main focus.

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