ROCKVILLE, Md., Nov. 3, 2009 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced that it has initiated the first of two pivotal Phase III clinical trials for NicVAX(R) (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. This study is being funded in part with a $10 million grant from U.S. National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol, increasing the possibility of a positive outcome.

"This is a significant step for Nabi, our shareholders and the millions of smokers around the world who want to quit smoking," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "We were very encouraged by the results of the phase IIb proof of concept and believe that since that study, we have improved the dosing schedule and the phase III NicVAX trial design. The initiation of the Phase III study solidifies our leadership position as the most advanced smoking cessation pipeline vaccine. We are encouraged by the increased interest in this program while we continue to pursue a strategic partnership for the continued development and commercialization of NicVAX."

How NicVAX Works

When nicotine enters the bloodstream, it quickly crosses the blood-brain barrier and binds to nicotinic receptors in the brain, triggering the release of stimulants like dopamine that provide the smoker with a positive sensation that eventually leads to addiction. NicVAX stimulates the immune system to produce antibodies that bind to nicotine creating an antigen/antibody complex that is too large to cross the blood-brain barrier. In this way, NicVAX blocks nicotine from reaching these 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 show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the nicotine antibodies circulate for long periods of time, Nabi believes NicVAX may also be effective in preventing smoking relapse. This is a very important difference between NicVAX and existing anti-smoking treatment therapies.