Buffalo, NY — For many smokers, the craving for nicotine is stronger than the will to quit. Now a clinical trial underway at Roswell Park Cancer Institute and 19 other sites across the nation will determine whether a new vaccine called NicVAX can power up the body’s own immune system to help conquer that craving.
Martin C. Mahoney, MD, PhD, Associate Professor, Departments of Health Behavior and Medicine, will lead the trial at RPCI.
How does the vaccine work? The nicotine in tobacco crosses the “blood-brain barrier” into the central nervous system, where it activates receptors to release dopamine and other neurotransmitters, or “chemical messengers,” which produce the pleasant sensation that drives various kinds of addictions, including nicotine dependence. NicVAX is designed to interfere with that process by producing antibodies “that serve as a sponge, soaking up the nicotine so there’s less of it circulating in the bloodstream,” explains Dr. Mahoney. With less nicotine crossing into the brain, “you don’t get the same strong satisfaction from smoking.” The hope is that this approach “will help people achieve long-term cessation by reducing both the repetitive reinforcement of smoking as well as craving and withdrawal.”
At each site, the Phase III clinical trial will enroll 50 smokers between the ages of 18 and 64. Half the participants will receive four doses of NicVAX (manufactured by Nabi Biopharmaceuticals), each dose four weeks apart, while continuing to smoke, while the control group will receive a placebo. For all participants, a quit-smoking date will be set for two weeks after the fourth injection, after which the test group will receive two additional “booster doses” to help keep them from starting up again.
Currently available nicotine-based smoking-cessation products—in the form of gum, lozenges, patches, nasal sprays, and inhalers—work in a different way, by delivering nicotine either in steady doses or at intervals, gradually reducing the amount over time, to wean smokers away from their need for the nicotine “rush.” It’s hoped that the nicotine vaccine will provide an effective alternative way to stop smoking for those who want to quit.
“Evidence-based recommendations advise combining some pharmaceutical intervention (medication) with counseling support to optimize quit rates,” notes Dr. Mahoney. “Participants in the nicotine vaccine study will receive the treatments, plus counseling support, free of charge.”
For someone who’s planning to quit, adds Dr. Mahoney, enrolling in the NicVAX clinical trial “can be an opportunity to help other generations of smokers” who will face the same challenge in the future.
MD Anderson and the Mayo Clinic are among the other major centers chosen as sites for the clinical trial. “We’re pleased and excited to have been selected,” says Dr. Mahoney.
Phase III clinical trials are the last step on the road to FDA approval of new drugs.
For more information about the NicVAX clinical trial at Roswell Park, call 1-877-ASK-RPCI (1-877-275-7724). Smokers who want to quit can also get help from the New York State Smokers’ Quitline, which is maintained by RPCI under a contract with New York State and offers free starter kits of nicotine patches, gum or lozenges, plus support and tips for success. For more information, call 1-866-NY-QUITS (1-866-697-8487) or visit www.nysmokefree.com.
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email firstname.lastname@example.org.
Annie Deck-Miller, Senior Media Relations Manager