I have written much about herpes vaccines, especially Genocea's GEN-003 and Rational Vaccines' Theravax (1,2). Although we are still years from having an approved herpes vaccine, this does not mean that nothing is happening.
Based on positive results from Phase II trials (Genocea presented its results at a poster session at IDWeek 2016, in New Orleans last October ), the company is preparing for Phase III trials in the US in 4Q 2017. The company says that enrollment is already complete.
Rational is taking a very different route. The company, founded by Dr. Bill Halford (3), an immunologist at the Southern Illinois University School of Medicine in Springfield, Illinois, decided to bypass the United States FDA entirely and conducted a 20-person pilot study on the island of St. Kitts using hand-selected patients. This decision raised more than a few eyebrows because of its controversial nature. Now the company has said that it plans to do a trial for Theravax in Mexico, which has a reciprocal agreement with Canada, so if the vaccine is approved in Mexico it would automatically be approved there as well. We'll have to see how it goes. At this time there are no published results from Rational.
Interestingly, they have said that herpes patients can gain access to this experimental vaccine, either by enrolling in a foreign clinical trial (the company says they are planning to start trials with about 40 participants) or by the company's compassionate use program, which is now being run in the Dominican Republic. All people who are interested should contact Minerva Labs, a contract research organization (CRO) there. I am listing their contact information for informational purposes only. I am not endorsing any company and as I have said many times, there is no data available from them. Use some caution and make sure you are engaging in informed consent since this is outside the United States.
Minerva Labs
www.minervalaboratories.com (Website is under construction)
Phone: 1-917-546-0973 or 1-844-726-7402.
Notes:
(1) You can read my interview with Genocea's CEO Chip Clark here.
(2) You can read my intereview with Rational's CSO Dr. Bill Halford here.
(3) Dr. Halford passed away in June after a five-year battle with a rare form of nasal cancer.
Josh Bloom
Dr. Jonathan (Josh) Bloom, ACSH's Director of Chemical and Pharmaceutical Sciences, earned his Ph.D. at the University of Virginia and completed postdoctoral training at the University of Pennsylvania. During his 20-plus years in drug discovery at Wyeth, his research group discovered the antibiotic Tygacil®, approved in 2005. He holds 25 issued patents and has authored 35 academic papers. Since joining ACSH in 2010, he has written more than 2,000 articles and dozens of op-eds for major newspapers, including The Wall Street Journal and Chicago Tribune.
