Breakthrough in Herpes Treatment Confirmed

[hippyherpy]

http://outbreaknewstoday.com/genital-herpes-treatment-genocea-biosciences-announce-data-from-phase-ii-trials-94143/

 

Cambridge, Mass. biopharmaceutical company, Genocea Biosciences, Inc., announced this week positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes.

 

GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.

 

“We are very pleased with these data, which show that GEN-003 has strong and durable effects on both HSV-2 viral activity and genital herpes clinical disease, supporting our belief that GEN-003 could become a cornerstone treatment for patients affected by this serious disease. Specifically, a single course of treatment of GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals – but with greatly improved convenience,” said Chip Clark, president and chief executive officer of Genocea. “We anticipate reporting virologic efficacy data for GEN-003 from our recently-initiated Phase 2b study in the third quarter of 2016, clinical efficacy data at 6 months post dosing around the end of 2016 and conducting our end of Phase 2 meeting with the FDA in the first quarter of 2017.”

 

“These 12 month data highlight the potential of GEN-003 to significantly enhance the genital herpes treatment landscape,” said Lori A. Panther, M.D., MPH, infectious diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School. “Because of the physical and psychological impact of this disease, both patients and treating physicians would be eager to use an effective treatment that more conveniently improves control of outbreaks. The reduction in viral shedding, which is thought to cause the epidemic spread of genital herpes, is also encouraging.”

 

Genocea has already advanced the two most promising doses, 60 µg per protein combined with either 50 or 75 µg of Matrix-M2TM adjuvant, from this Phase 2 dose optimization study into an ongoing Phase 2b efficacy trial. The efficacy of GEN-003 at these two dose levels over the course of the Phase 2 dose optimization trial is as follows:

 

Inducing a T cell response against HSV-2 is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T-cell directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea’s ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licenses from Novavax, Inc. For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.

 

Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.

[WCSDancer2010]

Well, that's great, but only Phase 2 ... so it will likely be about 5 yrs if we are lucky before it hit's the pharmacies :(

[whitedaisies]

Yeah I have ghsv1. I am shit out of luck I guess.

[hippyherpy]

Here's another recent thing:

http://medicalxpress.com/news/2016-04-key-immunizing-herpes-common-cold.html

 

Researchers at McMaster University have discovered a critical step in the immune system's recognition of DNA viruses. It's a key finding, they say, that could lead to vaccinations for herpes, the common cold or even cancer.

 

The study published today by the scientific journal Nature Immunology found that a protein, previously known to be involved in metabolism, is critical for the detection of the viruses. The co-authors are Brian Lichty and Yonghong Wan, both professors of pathology and molecular medicine for McMaster's Michael G. DeGroote School of Medicine.

 

This discovery is a significant advancement towards the development of vaccines for DNA viruses such as herpes and colds, says Lichty.

 

"We have identified an important step in the detection of DNA viruses by the immune system, and have shown that this is absolutely crucial in the response to a vaccine against these infections. If the key immune system component identified in these studies is not triggered, then vaccination fails."

 

Wan says this study could have further impact on a number of serious conditions and illnesses.

 

"This represents a breakthrough in our fundamental understanding of how our immune system detects a viral infection. But it goes beyond that, as this component of our immune system is also involved in detection of cancer by our immune system and is central to the development of autoimmune diseases," Wan said.

 

"So this discovery potentially impacts anyone infected by a virus, receiving a vaccination, fighting cancer or experiencing autoimmunity."

 

Prior to this study, it was known that interferon regulatory factor-3 (IRF-3), a protein coding gene, contributed to a first line of defense against viral infection by triggering antiviral activity. However the activation of IRF-3 following infection was not fully understood.

 

The study found that an interaction with the protein S6K1 and the signaling adaptor STING is a fundamental regulatory mechanism for IRF3 and, thus, helps trigger antiviral responses.

 

"Now that we have identified this aspect of the immune system, we can work on developing methods to engage this pathway during vaccination against viruses or cancer," said Lichty.

[WCSDancer2010]

Yeah I have ghsv1. I am shit out of luck I guess.

 

Odds are it will work for HSV1 as well - it's just that they are focusing on H2 for the study....

[Katidid]

This is very promising!

[hippyherpy]

Here's a new nano cream that deals with herpes in mice:

http://www.chicagomag.com/city-life/April-2016/UIC-Research-Herpes-Vaccine-Mice-Study/

The virus that causes genital herpes is incredibly common—about 15 percent of Americans ages 14 to 49 carry it—and an effective vaccine has been hard to find.

 

That’s because the herpes simplex virus-2—which also causes serious eye infections in babies and people with weak immune systems—spends so little time in our bloodstream, where most vaccines get to work. But researchers at University of Illinois at Chicago have seen a breakthrough (at least in mice studies) with a new approach that comes in the form of a topical cream.

 

Right now, people with genital herpes are limited to medications that will suppress the symptoms and decrease the number of flare-ups. The new study, published in the Journal of Immunology by UIC researchers and German scientists, shows that nanoparticles called ZOTEN are able to keep the virus from infecting cells and stimulate the immune system to fight the virus long-term.

 

“It possesses both microbicidal and vaccine-like properties," says Deepak Shukla, one of the researchers on the study. “It is a totally novel approach to developing a vaccine against herpes, and it could potentially also work for HIV and other viruses.”

 

Shukla, a professor at the UIC College of Medicine, expects human studies of the vaccine to come in the future, but in the meantime, he and other researchers will continue testing on non-human subjects to improve the way ZOTEN works. (The nanoparticles were synthesized by material scientists in Germany.)

 

In the recent study, female mice swabbed with the virus and the ZOTEN cream had significantly fewer lesions and less central nervous system inflammation than mice that were swabbed with the virus and placebo cream. By watching the nanoparticles interact with the virus and immune system cells, Shukla says they were able to see how it helps facilitate immunity, too.

 

Traditional preventative approaches “have failed against genital herpes and HIV,” Shukla says, which makes the success of this two-sided approach even more exciting for researchers. Though it’s still in early research stages, if the cream can proceed to clinical studies and be proven effective on humans as well, it could change the way we look at a virus that affects millions of Americans.

[hippyherpy]

Here's another recent stab at curing herpes: https://www.fredhutch.org/en/news/center-news/2016/09/can-gene-editing-cure-herpes.html

 

 

 

Scientists at Fred Hutchinson Cancer Research Center have used a gene-editing technique to attack the DNA of the herpes simplex virus in infected mice, a key step on the road to defeating an often-stigmatized virus that infects one in six people in the United States alone and for which there is no cure.

 

The study, published today in the journal JCI Insight, “lays out the pathway toward a potential cure for human herpesvirus infections,” said Dr. Keith Jerome, a Fred Hutch and University of Washington virologist and the paper’s senior author.

 

Researchers in Jerome’s lab deployed DNA-cutting enzymes called targeted endonucleases to damage the herpesvirus genome, inducing mutations that destroy the virus’ ability to replicate. The study is the first in a living organism — rather than a lab dish — to show that gene-editing tools can be delivered to the herpes simplex virus in its latent state or to a latent viral infection of any kind. Doing so is key to curing herpes because a latent infection can reactivate and seed new outbreaks.

 

“We can take these targeted endonucleases, we can introduce them into a mouse that has a latent herpes infection, we can get them to where the virus lies dormant and we can successfully attack that virus in its dormant state,” Jerome said. “The process can work.”

 

The plan going forward is to “optimize every step of the process,” including using a newer generation of gene-editing tools such as CRISPR (more on that below), to attack the virus more effectively and boost mutation rates enough for a true cure. Jerome said it would take “several years of work” before researchers could think about testing the approach in human trials.

 

“But we’re certainly thinking about that,” he said. “That is the goal.”

 

The physical — and psychological — toll of herpes

 

There are two types of herpes simplex virus. The most widespread is herpes simplex virus 1, or HSV-1, which is usually transmitted through mouth-to-mouth contact. During an active infection, HSV-1 can cause so-called cold sores around the lips. Globally, it infects more than 3.7 billion people under the age of 50, or 67 percent of the world’s population, according to the World Health Organization.

 

More troublesome is genital herpes, which is usually caused by herpes simplex 2, or HSV-2, and affects about 417 million people, or about 11 percent, worldwide. It is transmitted through skin-to-skin contact during vaginal or anal sex and can cause painful genital and anal lesions. Another 140 million people have genital lesions caused by HSV-1 transmitted through oral sex, bringing the total number of those with genital herpes to more than half a billion.

 

With genital infections, the virus can be passed to newborns, a “devastating complication” that can cause serious illness or death if not treated early, Jerome said. In people with suppressed immune systems, such as those undergoing chemotherapy or other cancer treatments, sores can be severe. Genital lesions also can increase the risk of transmitting or getting HIV.

 

Then there’s the psychological toll. The U.S. Centers for Disease Control and Prevention states that 776,000 Americans are newly infected with genital herpes each year. Even when symptoms are nonexistent, mild or suppressed by medication, infected people can still spread the disease to their sexual partners, making a genital herpes diagnosis a source of embarrassment, shame or stress that can interfere with relationships.

 

“I felt like someone had just shot me in the chest every single day for those first six months,” wrote Ella Dawson, a self-described feminist millennial sex writer who was diagnosed with genital HSV-1 at age 21 and has since written openly about it in an effort to eradicate the stigma.

 

Numerous online support groups provide a safe place for the newly diagnosed, who often prefer to be identified only by their screen names, to talk about such things as when to have “The Talk” with a potential romantic partner.

 

“While many people associate herpes with outbreaks, they don't realize the emotional pain it causes,” said "Dex," who created and runs an online dating site for people with herpes. “The stigma of herpes is often worse than the physical effects. It's not like you can easily tell your friends and family of your new herpes diagnosis. In our world, it is known as ‘The Talk.’ Often, the fear of rejection and the anxiety can keep some from attempting to date at all.”

 

A cure, Dex said in an email, “would mean so much to so many.”

 

Reaching the latent virus

 

HSV infections occur at mucosal surfaces — the mouth, the genitals. The virus is then picked up by sensory nerve endings on those surfaces and travels along axons to neuronal cell bodies, where it persists in a dormant state. But unlike some other lifelong infections that have latent stages — HIV, for example — dormant herpes simplex viruses rest in just two places in the body: a nerve cluster called the trigeminal ganglion in the skull for HSV-1 and, for genital herpes, the dorsal root ganglia adjacent to the spinal cord.

 

Having these virus dormitories confined to such specific sites is a huge advantage for researchers seeking to cure herpes, as is the relatively small number of neurons infected. By comparison, said Jerome, latent HIV is found in T cells, which are everywhere in the body, and researchers still don’t know the full extent of the latent HIV reservoir.

 

 

 

[hippyherpy]

This is getting headlines in the national news with people like Thiel and Trump investing. It's a vaccine that is working for trial participants. https://www.cnbc.com/2017/09/01/herpes-vaccine-firm-backed-by-peter-thiel-promises-fda-oversight.html