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Home » NABI COMPLETES ENROLLMENT OF NICVAX TRIAL
NABI COMPLETES ENROLLMENT OF NICVAX TRIAL
July 20, 2005
Nabi Biopharmaceuticals announced that it has completed enrollment for its European-based NicVAX Phase II dose-ranging study in smokers. NicVAX is a novel, innovative, and proprietary investigational vaccine being developed to prevent and treat nicotine addiction.
The study, designed to evaluate NicVAX's safety, antibody response to nicotine, and measure smoking cessation/nicotine dependency, is a randomized dose-ranging study in smokers. The four NicVAX dose levels, 100, 200, 300, and 400 mcg per injection, will be given over a six-month period with 10 patients included per dose group. Based on clinical trial results generated to date, Nabi Biopharmaceuticals has observed no significant toxicity through the 200 mcg dose level, hence the current study is designed to evaluate whether higher doses of NicVAX could further increase anti-nicotine antibody levels without increasing toxicity.
KEYWORDS Drug Pipeline Alert
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