Nabi Biopharmaceuticals announced the start of its Phase II clinical trial of NicVAX (Nicotine Conjugate Vaccine) being conducted with smokers at three sites in the United States. NicVAX is a proprietary vaccine that is being developed to prevent and treat nicotine addiction. NicVAX stimulates the human immune system to produce nicotine specific antibodies that bind nicotine molecules in the blood system, blocking it from reaching the brain, thereby preventing the nicotine "rush" which researchers believe is the main reason many smokers find it so difficult to quit smoking.

"NicVAX represents a novel and innovative approach to the treatment of nicotine addiction and the start of this Phase II trial in smokers represents the accomplishment of another exciting milestone in our NicVAX clinical development program," said Robert Naso, Nabi Biopharmaceuticals senior vice president of research and development. Dr. Naso continued, "This trial represents an important next step in helping us to further determine thesafety of NicVAX and the ability of the vaccine to generate nicotine specific antibodies. We will also begin to evaluate the potential benefits from NicVAX in treating nicotine addiction and in aiding smoking cessation."

The trial is a randomized, double-blind, placebo-controlled study at three different study sites in the United States. Three different dosage levels of NicVAX will be evaluated in three groups of patients with twenty-one patients in each group. Up to four doses of NicVAX will be administered to each patient over the course of the trial. The primary endpoints of the study will evaluate nicotine specific antibody levels, trends in smoking habits during the trial, and safety and tolerability of the vaccine (local and systemic reactions and adverse events).