ROCKVILLE, Md., Oct. 28, 2009 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced that it is participating in an investigator initiated Phase IIb study to evaluate the safety and efficacy of NicVAX(R) (Nicotine Conjugate Vaccine) when co-administered with varenicline as an aid to smoking cessation and relapse prevention. This study will be conducted by The Research School CAPHRI of the Maastricht University Medical Center in Maastricht, The Netherlands and will be funded primarily by The Netherlands Organization for Health Research and Development and Maastricht University with Nabi providing some additional support.

"In our proof-of-concept trial, NicVAX demonstrated that high levels of anti-nicotine antibody in response to NicVAX immunization increases the ability of smokers to quit smoking and remain abstinent," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "The Maastricht study will focus on NicVAX's ability to prevent relapse in smokers who initially quit upon treatment with varenicline. We believe NicVAX, given its unique long-acting effect will help smokers quit and kick the habit for good, whether they initially quit smoking on NicVAX or another smoking cessation therapy. Results from this study will enable us to maximize the commercial potential of NicVAX as both a mono-therapy and a combination therapy."

About the Phase IIb Study

The Phase IIb study for NicVAX is a double-blinded, placebo-controlled parallel-arm study comprised of approximately 600 patients randomized in a 1:1 ratio to one of two treatment groups. One group will receive NicVAX and varenicline and the other group will receive placebo and varenicline. The primary endpoint of the study is the long-term smoking abstinence rate at one year. Abstinence will be evaluated by self-reported cigarette consumption and measurement of exhaled carbon monoxide. Secondary endpoints include the abstinence rate at various interim periods, smoking lapse and relapse, safety, immunogenicity and withdrawal symptoms. The study also will involve behavioral counseling as with other smoking cessation programs which likely will enhance efficacy rates in this study.

About NicVAX

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.