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.
