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Sometimes diseases or infections are tough nuts to crack no matter how much money or research effort is thrown at them (e.g., Alzheimer's, Parkinson's). Genital herpes has earned a place on that list.

One experimental vaccine after another has failed, although one of the first ones - Genocea's GEN-003 remains in the running after showing some efficacy at higher doses after it disappointed in Phase II trials at lower doses. And pritelivir, a promising looking antiviral drug that works by inhibiting viral DNA synthesis (...

Sometimes drugs behave very well. They do what they are supposed to so, and do it well, maybe even without side effects (1). We are fortunate to have one of these that works against a very common infection—herpes simplex virus (HSV). 

There are two versions of the virus. HSV-1 is the type that causes cold sores, and HSV-2, which causes genital herpes (2). The two viral types are similar enough that they both respond well to the same drug—acyclovir (3).  The way that acyclovir works is a textbook example of an antiviral drug in action—shutting down an essential step that brings viral replication to a halt. The essential step that is shut down is the prevention of the formation of a phosphate ester bond—a key step in the...

Based on the recent demise of experimental vaccines from Genocea and Vical the prospects for a therapeutic vaccine for genital herpes look mighty bleak at this time. So, for most patients who need treatment valacyclovir (Valtrex) is the only choice (1,2). It works well for most people, but not for everyone.

DRUGS VS. VACCINES FOR TREATMENT OF INFECTIOUS DISEASES

There has never been a therapeutic vaccine for any infectious disease, and there isn't one on the horizon. But there are plenty of drugs that work quite well for infections - antibiotics, antifungals, and antivirals. Since herpes is a viral infection is it not unrealistic to predict that an antiviral drug that works better than Valtrex could be discovered. Based on the stunning success of...

Richard Mancuso is one of the 17 (1) patients who participated in the highly controversial Theravax herpes vaccine trial in St. Kitts. Mancuso was in New York for media appearances promoting his new book, "Asking For A Friend." (2) He kindly took the time to stop by our office and answer questions about his personal experiences with the vaccine, the company (Rational Vaccine) and its founder, Dr. Bill Halford.

JB: Richard, thanks for agreeing to speak with me about this very controversial topic. Can you explain how you first became involved with Bill Halford and Rational?

RM: As a long-time herpes sufferer I was a member of many Facebook groups. Just by chance, one of the admins saw my post and photos of a herpes outbreak on my left cheek...

Recently I gave a brief update on the progress of VCL-HB01, an experimental therapeutic vaccine for genital herpes, which is being developed by Vical, a San Diego-based biopharmaceutical company. The update was brief because there was little new information on the progress of the vaccine as it made its way through human clinical trials.

But Larry R. Smith, Ph.D., who is Vical’s Senior Vice President of Research agreed to answer some questions about the progress of the vaccine. 

JB: There has been considerable controversy about the utility of synthetic vs live attenuated vaccines for either treatment or prevention of genital herpes. This issue...

Chip Clark, Genocea's CEO, kindly agreed to answer my questions about the company's GEN-003 herpes vaccine, and provide an update on the vaccine's progress. I would like to thank Chip for taking a considerable amount of time to speak with me. The interview below should answer some of the many questions that readers have been writing and calling about.

JB: Can you update us on Genocea's current plans and timelines. If all goes well, can you estimate when the Biologics License Application (BLA) might be granted? (1)

CC: Genocea is currently finishing up its Phase II program on GEN-003, and recently had a successful end of Phase II meeting with the FDA. In the middle of the year, we expect to announce the 12-month placebo-...

During the past 9+ decades, vaccines for genital herpes have come and gone. Make that gone and gone. This is because, despite nearly a century of research, there is still not a single vaccine that can treat or prevent either HSV-1 (commonly known as oral herpes) or HSV-2 (genital herpes) (1). The two viruses together infect about two-thirds of the people in the world. 

But perhaps we are nearing the time when some news, hopefully good, will be coming from Vical, a San Diego-based biopharmaceutical company, which I wrote about earlier this year when its cytomegalovirus (2) vaccine failed. Phase II results of VCL-HB01, the company's therapeutic vaccine...

If you ever need a reminder about how difficult it is to discover new drugs or vaccines, here it is. Despite 100 years (!) of research we still don't have a vaccine for herpes simplex (1,2). 

There is now another failed herpes vaccines, but this time it's not bad news for genital herpes sufferers. Vical, a California-based biotech, announced that its vaccine for cytomegalovirus (CMV) doesn't work and will be dropped. But, what does this have to do with herpes?

Most people know very little about CMV (3). Although the virus, is not a problem for most of us, it can cause very serious infections for people with compromised immune systems, especially transplant patients. CMV has another name: Human herpesvirus...

Good news in the world of virology.

For the first time, there is a promising vaccine to treat Herpes Simplex Virus type 2 (HSV-2), commonly known as genital herpes. HSV-2 is an infection that infects 500 million people worldwide, and 24 million in the United States, second in prevalence only to HPV among sexually transmitted viruses in the U.S. (The far more common herpes, which causes cold sores, is HSV-1.)

The vaccine, which is called GEN-003 is currently in Phase II trials (1), where it is doing rather well. More on this later.

For being such a common infection, there are big gaps in public knowledge about herpes, so here’s a quick primer:

  • Herpes never...

On September 26th, I wrote about Rational Vaccines (RVx), an Illinois-based company, which was formed in 2015 to develop vaccines that would prevent and treat herpes simplex virus-2 (HSV-2), which causes genital herpes, and HSV-1, which also causes genital herpes as well as cold sores (1).

At that time, based on unpublished data from a study of the protective effects of their vaccine in mice and guinea pigs (2), it seemed that RVx’s live-attenuated herpes vaccine might have a significant advantage over Genocea’s GEN-003 subunit vaccine—the first-ever vaccine to treat HSV-2 in humans, which...