Nabi begins phase 2b proof-of-concept study of NicVAX nicotine addiction vaccine

By Lisa Kerner

Erie, Pa., May 24 - Nabi Biopharmaceuticals said it has started a phase 2b proof-of-concept study of an optimized formulation of NicVAX (Nicotine Conjugate Vaccine), its novel proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

The study protocol is based on consultations with U.S. and EU regulators on the design and endpoints for phase 3 efficacy studies, according to a company news release.

Approximately 300 people will be enrolled in the double-blind, placebo-controlled, dose ranging study. The primary endpoint of the study is the abstinence rate at six months, with secondary endpoints of the abstinence rate at 12 months, total cigarette consumption, titer levels, safety and nicotine dependency.

Results from the phase 2b study are expected in mid-2007, followed by phase 3 efficacy studies in the second half of the year.

"This is an important milestone for Nabi Biopharmaceuticals and for the over one billion smokers in the U.S. and across the world who want to quit their addictive habit," chairman, chief executive officer and president Thomas H. McLain said in the release.

NicVAX works by stimulating the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain. The nicotine antibodies will act like a sponge, soaking up nicotine in the bloodstream and preventing it from reaching the brain.

By preventing the pleasurable response that occurs when nicotine reaches the brain, NicVAX removes what is believed to be the main reason that people cannot stop smoking.

The Food and Drug Administration granted fast track status to NicVAX in March.

Rockville, Md.-based Nabi develops and markets products in the core business areas of gram-positive bacterial infections, hepatitis and transplant, kidney disease (nephrology) and nicotine addiction.

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