I have been paying close attention to the rapid developments in the race toward the world's first genital herpes vaccine. Since we first wrote about Genocea's GEN-003 efficacy in infected people this past March, hundreds of thousands of people have been following the vaccine's progress on this site alone.
This past September, I wrote about a small biotech, Rational Vaccines (RVx), which was co-founded by immunologist Dr. William Halford, an Associate Professor of the Southern Illinois University School of Medicine. To-date, Rvx had only conducted a very small (20 person) pilot study in St. Kitts, and claimed that the company's Theravax HSV-2 vaccine yielded results that sounded too good to be true.
(A comparison of the two vaccines, though difficult since one has published data in the US and one has only grey literature claims from a pilot program overseas, can be found here.)
When I interviewed Dr. Halford, he made it clear that RVx was going not going to try and get FDA approval, which is a worrisome sign, and would instead conduct a series of smaller trials in developing countries that have less stringent requirements, another worrisome sign. Obviously people wanted to know how they might get into a trial for Theravax.
No answers were forthcoming. Then late last week, OncBioMune Pharmaceuticals Inc., a biotech in Baton Rouge, LA announced that it was discussing a merger with the Mexico-based biopharmaceutical Vitel Laboratorios to develop a number of cancer drugs and vaccines in Mexico. One of these vaccine was RVx's Theravax. Does that mean that RVx will be conducting clinical trials in Mexico?
Halford won't say if Mexico is involved at all. Will Rvx go south (of the border)? It sure makes sense, given his desire to run tests without FDA oversight, but only time will tell.
Stay tuned. As soon as I learn anything I will let you know immediately. In the meantime, if you want to read about all of the herpes vaccines candidates, please click here.