Researchers Investigating Anti-Nicotine Vaccine
Experts estimated that 500,000 Americans die each year from health complications related to smoking. Researchers said nicotine addiction is one of the nation’s major health issues, and although many smokers try to quit, most don’t succeed.
“Seventy percent of these individuals that want to stop smoking relapse within a one-year period,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse.
Some experts believe that a vaccine could be the answer to helping smokers quit for good.
According to Volkow, the study results so far on an anti-smoking vaccine from Nabi Biopharmaceuticals have been promising, so they awarded $10 million to the company for further research.
The vaccine known as Nicvax is designed to prevent nicotine from entering the brain. Without nicotine in the brain, the smoker doesn’t get the “high” that causes addiction. In prior studies, smokers were given five vaccines over a six-month period. The effect lasted about a year.
Researchers said approximately 35 percent of those taking the vaccine actually quit during the study time.
“It would be ideal, if we could generate vaccines that would require one or two boosters and you’d have a much longer duration of protection,” said Volkow.
The first part of the phase three human trials involving 1,000 patients began earlier this month.
NicVAX ®(Nicotine Conjugate Vaccine)
NicVAX is an investigational vaccine designed as an aid to smoking cessation, as well as an aid to prevent relapses of a treated smoker
NicVAX represents an extension of our conjugate vaccine technology that allows us to address a significant medical need. We believe that broad commercialization of NicVAX will be in conjunction with a marketing partner that has a demonstrated expertise in executing large scale sales and marketing programs because the physician audience will likely be primary care physicians and focused outside the hospital setting.
Nicotine is a small molecule that upon inhalation into the body quickly passes into the bloodstream and subsequently reaches the brain by crossing the blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine receptors, which results in the release of stimulants, such as dopamine, providing the smoker with a positive sensation, which causes addiction. NicVAX is designed to stimulate the immune system to produce antibodies that bind to nicotine in the bloodstream and prevent it from crossing the blood-brain barrier and entering the brain. Therefore, the brain does not produce the positive-sensation stimulants as a response to nicotine. Pre-clinical animal studies with NicVAX have shown that vaccination could prevent nicotine from reaching the brain blocking the effects of nicotine, including effects that can lead to addiction or can reinforce and maintain addiction.
Nicotine addiction is difficult to treat effectively. We believe NicVAX has advantages over existing treatment therapies because its effect is irreversible for potentially six to 12 months following vaccination as antibodies to nicotine continue to be produced by the body?s immune system. This is important due to the extremely high relapse rate that has been observed when a smoker attempts to quit smoking. Currently, smokers being treated for nicotine addiction can stop using their therapy and resume their addiction.
In September 2005, we were awarded a $4.1 million grant by the U.S. National Institute on Drug Abuse, or NIDA, partially offsetting our funding requirements for the NicVAX development program.
Following the award of the NIDA grant, we formed a scientific advisory panel to provide us guidance on clinical trial design and clinical development plans for NicVAX.
November 10, 2009
