Fidelity:

November 16, 2009

(Boston Herald) -- Leslie Cook was losing control of her life one cigarette at time, 20 cigarettes a day.

The 53-year-old Boston real estate lawyer spent nearly half her life smoking, and nothing -- not patches, gum, gurus or drugs -- loosened the grip of nicotine.

"I just felt like it owned me. It controlled me," said Cook, who finally kicked the habit in 2007 with the help of an experimental vaccine called NicVax, which took away the pleasure of nicotine.

"I don't miss it to this day," said Cook, who participated in a clinical trial at Massachusetts General Hospital testing the drug.

Buoyed by the success of the first trial, MGH researchers are looking for more smokers like Cook who are willing to join in the third and final phase of a clinical trial testing the crave-curbing vaccine. Last week, researchers enrolled 50 smokers.

"This is such a novel approach. It's exciting that it has gotten to this phase," said Dr. Nancy Rigotti, director of the MGH Tobacco Research and Treatment Center.

Here's why it works, she said:

Smokers get a hit of nicotine each time they take a puff. The nicotine travels from the lungs to the blood to the brain, where it triggers the pleasurable feeling of satisfaction that keeps smokers hooked.

The vaccine creates anti-nicotine antibodies that bind to nicotine in the blood and stop the chemical from reaching the brain.

"By depriving nicotine access to the brain you keep it from the ability to be rewarding," Rigotti said. "If you smoke and you don't get any pleasure from it, it becomes less rewarding to smoke. Over time, you say, `Why bother?' "

In an earlier trial at MGH, 16 percent of people on NicVax quit smoking for at least a year, compared to 6 percent with a placebo. No dangerous side effects were reported, Rigotti said.

Rigotti said there's much to learn about the vaccine, but so far it looks promising. For example, it's unclear how long the antibodies work or if the vaccine could someday be used on nonsmokers.

Nabi Biopharmaceuticals in Maryland, which makes NicVax, must test the vaccine in two large-scale clinical trials before the Food and Drug Administration could approve it, said spokesman Greg Fries. The FDA has fast-tracked the drug for approval, he said.

The market for the vaccine is huge, he said. Roughly 45 million Americans smoke and about 5 percent manage to quit each year. Chantix, a nicotine-curbing pill made by Pfizer Inc. that blocks nicotine from reaching receptors in the brain, is on the market.

"It's a huge unmet medical need," Fries said. "The things that are out there to treat smoking -- patches, gums, lozenges, are nicotine replacement therapy. It doesn't really help people break the addiction to nicotine. It provides nicotine from a different source."

MGH is one of 21 sites participating in the first of the large-scale trials. Participants must be at least 18, smoke 10 or more cigarettes a day, want to quit and be healthy. Patients will get six shots over six months. Half receive a placebo. To enroll, call 617- 724-3157 or e-mail mghsmokingstudies@gmail.com.