The last time I wrote about one herpes vaccine - in that case Rational Vaccines' (RVx) Theravax, which claims to have performed well but only in one very pilot study in one foreign country, with no published data - I noted that future studies would be done in Mexico. (See: Herpes Vaccine Heads South ... Of The Border?", November 13, 2006.
The pilot study consisted of under 20 patients, and they published no data or methodology, but the company claims the results were encouraging. They also said they are planning more trials, but they would be held outside to the US to circumvent the FDA—an agency that Dr. William Halford, the inventor of the vaccine and CSO of RVx, has little regard for.(1)
But despite the fact that conducting trials in Mexico makes sense, given his strategy so far, it was no more than an educated guess. Since November-- nothing. Not a word. Until today.
A new report by CBS medical correspondent Dr. Max Gomez says they are beginning a Phase II study, dose-ranging, designed to determine the optimal dose for the vaccine. And that Americans may be able to try it, if they are willing to go to Mexico.
There are red flags but the CBS report can be seen as hopeful for the millions of patients who are awaiting a breakthrough therapy to treat their infections:
"The company is now starting a phase 2 efficacy and dosage trial, but FDA approval for vaccines is a long process, so they expect the vaccine to first be available in the Caribbean and Mexico where Americans may be able to get it."
Dr. Max Gomez- January 6, 2017
I spoke with Dr. Halford this morning, and he again wouldn't provide any details. If that changes, you will be able to read it here right away.
Keep 'em crossed.
For my other articles on herpes vaccine candidates, please click here.
Josh Bloom
Director of Chemical and Pharmaceutical Science
Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.
