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!