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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

nd Long-Term Abstinence

A statistically significant number of patients treated with the NicVAX(R) optimal dose (400 micrograms) and schedule (Schedule 2) were able to quit smoking and remained abstinent over the long-term:

* 12-Month continuous abstinence: NicVAX(R) 400 micrograms, Schedule 2 =

16% (8/51), Placebo=6% (6/100), p<0.038 (intent to treat population)

* 12-Month continuous abstinence: NicVAX(R) 200 micrograms, Schedule 2 =

14% (7/50), Placebo=6% (6/100), p<0.056 (intent to treat population)

* For the final 12-month data analysis, this response was calculated

using total time after the Target Quit Date, rather than the general

study week (which was used in interim data analyses). This

conservative and stringent statistical approach yielded

statistically significant findings even after a full year.

Anti-Nicotine Antibody Levels Drive Long-Term Smoking Abstinence

* The rate of smoking cessation and ability to achieve long-term

abstinence in treated patients was correlated with level of anti-

nicotine antibodies at critical time points: The high antibody

responder group (top 30% of antibody responders) showed continuous

abstinence rates almost three times those of placebo at 12 months.

* These high antibody responders continued to show statistically

significant abstinence at 12 months:

* NicVAX(R)= 16% (10/61) vs. Placebo= 6% (6/100), p<0.032

* Subjects in the therapeutic effect window show a >30% likelihood of

achieving at least four months of smoking abstinence and remaining

entirely abstinent through 12 months following the first administration

of NicVAX(R).

Overall Health Benefit - High Antibody Responders Smoked Fewer Cigarettes

Those patients in the NicVAX(R) group who continued to smoke but who also showed a high antibody response (top t
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SOURCE Nabi Biopharmaceuticals
Copyright©2007 PR Newswire.
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