We 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.
Then things started getting interesting.
This past September, we wrote about a small biotech, Rational Vaccines (RVx), which was founded by immunologist Dr. William Halford, an Associate Professor of the Southern Illinois University School of Medicine. Rvx conducted a very small (20 person) Phase I clinical trial in St. Kitts, which showed that the company's Theravax HSV-2 vaccine yielded results that sounded too good to be true.
(A comparison of the two vaccines can be found here.)
When I interviewed Dr. Halford, he made it clear that RVx was going to bypass the FDA entirely, and conduct a series of smaller trials in countries that have less stringent requirements for vaccine development. Public interest in Theravax seemed to exceed even that of GEN-003, which was evident by the hundreds of people who wrote to us and (probably) thousands who contacted Rvx, all wanting to know how they might get into a trial for Theravax.
But, we had no answer. Aside from the strategy of going outside the US, there was no information on how or where trials would be conducted. There is still no answer (yet), but there is now a clue. 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.
So, does this mean that RVx will be conducting clinical trials in Mexico? And if so, how many people will be enrolled, and where will the trials be held?
Since this partnership is a work in progress, Dr. Halford cannot even reveal whether Mexico is involved at all, let alone provide any details. Will Rvx go south (of the border)? It sure makes sense, but only time will tell.
Stay tuned. As soon as we learn anything we will let you know immediately.