August 28, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Rational Vaccines, a biotech co-founded by Oscar winning producer Augustin Fernandez III, has been developing an offshore treatment for herpes and recently picked up some strong financial backing from entrepreneur and President Donald Trump ally Peter Thiel.
Thiel, along with other investors, forked over $7 million to finance the drug testing, which is being conducted on the Caribbean island of St. Kitts. In an interview with BioSpace earlier this year, Fernandez talked about the company’s decision to develop the drug outside of the United States. Fernandez said there were two primary reasons the fledgling company opted to work outside the United States and that was due to the U.S. Food and Drug Administration’s lengthy drug-approval process, as well as the regulatory agencies “unfavorable view” of the use of live vaccines.
The decision to develop the drug offshore is raising some red flags in the regulatory sector because Rational Vaccines opted not to include an institutional review board to monitor safety in the trial, according to a Kaiser Health News report. Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division, told Kaiser that such safety boards are critical and slammed Rational Vaccines for being unethical. He said such safety precautions are necessary because the use of live vaccines can be risky and people can die.
Before a drug is approved by the FDA, Kaiser said a review by an IRB or its international equivalent is required. Former FDA Commissioner Robert Califf said there’s a long-time tradition for having such clinical oversight.
“It may be legal to be doing it without oversight, but it’s wrong,” he told Kaiser.
Others also echoed those statements, including some decrying the decision to not establish an IRB as a major setback in “human-subject protections” established since the end of World War II.
Rational Vaccines defended the lack of an IRB by saying there was little risk for the patients involved in the trial because they already had herpes, Kaiser noted. Fernandez told Kaiser that he intends to continue with the trials offshore and hopes that the results will be strong enough for the FDA to eventually approve the treatment.
Rational’s vaccine is based on science developed by William Halford, an associate professor of Microbiology and Immunology at Southern Illinois University School of Medicine in Springfield, Illinois. Halford has studied the herpes simplex virus for 25 years and in 2006 became interested in trying to develop a vaccine for HSV-2, one of the genital herpes strains. In the fall of 2016, Rational announced the successful completion of its Phase I trial for Theravax, a live vaccine for treatment of HSV-1 and HSV-2 for patients who suffer with recurrent genital herpes. The trial treated 17 patients with three doses of the vaccine and each of the patients indicated Theravax was “was more effective in reducing their genital herpes symptoms than antiviral drugs,” according to a company statement.
Thiel did not respond to Kaiser’s requests for an interview. Known for his backing of Facebook and PayPal, Thiel served as an adviser of sorts to Trump in selecting a commissioner for the FDA. Thiel has been outspoken in his criticism of the FDA. Current FDA Commissioner Scott Gottlieb has also criticized the FDA for its slow approval process.
