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Nicotine vaccine to be tested at Mass. General Hospital
Clinical trial will investigate new way to assist smokers seeking to quit

BOSTON - May 30, 2006 - A novel approach to helping smokers kick the habit - a vaccine - will be tested at Massachusetts General Hospital (MGH). The nicotine vaccine NicVax is designed to keep nicotine from reaching the brain where it produces its rewarding effects. Earlier studies of the vaccine, which has not yet received FDA approval, have indicated that it is safe and may be effective.

"We currently have several proven ways to help smokers quit - including nicotine patches and gum and the antidepressant bupropion - but if someone using these medications slips and smokes a cigarette, he or she experiences rewarding sensations from smoking," says Nancy Rigotti, MD, director of the MGH Tobacco Research and Treatment Center, who will lead the study at the hospital. "Since this vaccine keeps nicotine out of the brain, smoking no longer has any pleasurable effects, and the smoker should find it easier to quit."

Although the immune system does not normally respond to nicotine, NicVax - manufactured by Nabi Biopharmaceuticals, which is sponsoring the current trial - is designed to elicit the production of nicotine antibodies. If someone smokes after being immunized, the antibodies bind with nicotine molecules in the bloodstream and prevent them from entering the brain where nicotine receptors are located. Previous research has shown that, since antibody levels rise slowly, smokers lose the nicotine reward gradually, avoiding withdrawal symptoms. Rigotti explains that, once antibodies have reached ideal levels, nicotine is blocked from the brain. "While the vaccine doesn't prevent a person from smoking, it makes it not worthwhile to smoke," she explains.

The MGH is one of ten centers across the country participating in the current study and is the only location in the Northeast. Eligible participants will be healthy smokers, aged 18 and older, who are motivated to quit. During the first half of the yearlong trial, participants will receive four or five injections of either NicVax or a placebo, and all will receive smoking cessation counseling. Participants will be followed for an additional six months, will be reimbursed for parking fees and also will receive cash compensation based on how many study visits they complete.

Note: because of the response to this news release, no more participants can be enrolled in this study.

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of nearly $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, transplantation biology and photomedicine. MGH and Brigham and Women's Hospital are founding members of Partners HealthCare HealthCare System, a Boston-based integrated health care delivery system.

Media Contacts: Sue McGreevey, MGH Public Affairs
Valerie Wencis, MGH Public Affairs

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