Today, November 3, 2009 Nabi Biopharmaceuticals announced Phase three of a clinical trial for NicVAX. This is a vaccine to help smokers quit the habit. It will be conducted on 1000 patients over a period of 12 months. The results of the trial will be available in the third quarter of 2011. This study is funded in part by a $10 million grant from U.S. National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
The following is an excerpt from the press release.
“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. 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.
About the Phase III Study
The initial Phase III study for NicVAX is a double-blinded, placebo-controlled study comprised of approximately 1,000 patients. The primary endpoint of the study is the abstinence rate at 12 months. Abstinence will be evaluated by several measures, including self-reported cigarette consumption, and exhaled carbon dioxide. Secondary endpoints include the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency.“
