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Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
Date:11/7/2007

tion and other global regulatory agencies and incorporates the most current clinical trial standards and prevailing protocol design for smoking cessation studies. The trial's primary endpoint is the rate of carbon monoxide (CO)-confirmed, continuous abstinence from smoking during weeks 19-26 after first vaccination. In May 2007, Nabi announced this trial's six-month data, which showed that a statistically significant number of patients with in the high anti-nicotine antibody responder group met the trial's primary endpoint of eight weeks of continuous abstinence between weeks 19-26.

About NicVAX(R)

NicVAX(R) is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. NicVAX(R) is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX(R) blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. Pre-clinical and previous clinical data, as well as the study reported here, show that NicVAX(R)'s ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes NicVAX(R) also could be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers and, with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.

NicVAX(R) Development Progress to Date

In September 2005, Nabi announced that it received a $4.1 million grant from the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health. NIDA has also funded, in part, the costs for toxicology testing and earlier clinical trials in the U.S. a
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SOURCE Nabi Biopharmaceuticals
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