University of Minnesota reseachers plan clinical trial for nicotine vaccine

Dorothy Hatsukami, University of Minnesota Masonic Cancer Center

MINNEAPOLIS, Minnesota — A breakthrough vaccine to help smokers break their addiction to nicotine is within striking distance of regulatory approval, thanks in large part to tobacco researchers at the University of Minnesota.

Scientists at the school’s Masonic Cancer Center are recruiting patients for a Phase 3 trial of NicVax, an experimental nicotine vaccine developed by Nabi Biopharmaceuticals in Maryland. Phase 3 is the last clinical stage before Nabi seeks approval from the Food and Drug Administration. Last year, the National Institute on Drug Abuse awarded Nabi a $10 million grant to conduct the Phase 3 trial at 21 sites across the United States.

Dorothy Hatsukami, the site’s lead researcher who serves as the center’s associate director of cancer prevention and control, has been testing the vaccine for a decade. She also leads the Tobacco Use Research Center.

Nicotine binds to certain receptors in the brain, triggering the release of dopamine, a pleasure inducing stimulant that ultimately leads to addiction. NicVax prompts the body to produce antibodies that bond with nicotine molecules, making them too big to move from blood to the brain.

In November, Nabi struck a licensing agreement with drug giant GlaxoSmithKline to further develop and sell NicVax, a deal potentially worth $500 million, including an up-front fee of $40 million.