- Will any drug ever make the human mind overcome the sense of emotional loss associated with the end of a long and intense relationship?
- If NicVAX can successfully block nicotine from releasing dopamine, does that mean that quitters will get to experience full blown physical nicotine withdrawal while continuing to smoke? Will they still be called quitters?
- What about psychological recovery and all our habit triggers and the psychological craves that come with them? What will NicVAX block or bind to when there's nothing to block or bind?
- Will NicVAX teach quitters anything about living life without nicotine?
- Also, keep your eye on what goes into the placebo (any additives)and how that group's success rates compare to historical rates for ignorant, uneducated and unsupported abrupt cessation quitters - 10 to 12% at six months and 5 to 6% at one year.
- What will be the real cost?
John - Freedom's Gold Club
of Novel Vaccine to Fight Nicotine Addiction
ROCKVILLE, Md., June 12 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: announced today that they have initiated NicVAX(TM) (Nicotine Conjugate Vaccine) phase I testing in humans. NicVAX is a proprietary and novel investigational vaccine designed to help the body develop antibodies that bind to nicotine and block it from reaching the brain. If shown to be safe and effective in subsequent clinical trials, NicVAX may help millions of people worldwide kick their addiction to cigarettes and tobacco products.
"NicVAX is an entirely new approach to fighting and preventing nicotine addiction," said David J. Gury, Nabi Biopharmaceuticals chairman, president and chief executive officer.
Of the 48 million adult U.S. smokers, about 70 percent, or nearly 34 million people have made at least one attempt to stop, yet only 1.2 million quit permanently, according to the U.S. Centers for Disease Control and Prevention.
"The reason quitting smoking is so difficult is because nicotine is highly addictive," according to Robert Naso, Ph.D., Nabi Biopharmaceuticals senior vice president of quality, regulatory and product development. "When a person smokes, nicotine enters the body and goes straight to the brain, where it generates positive sensations, such as pleasure and relaxation. However, the body does not develop antibodies against nicotine, no matter how much or for how long a person smokes. Based on earlier animal studies, NicVAX is a technology that enables the body to develop antibodies to nicotine. We believe that these antibodies, acting much like a sponge, will soak up the nicotine, preventing it from reaching the brain."
"By reducing the amount of nicotine available to stimulate the brain's pleasure centers, an immunized tobacco user would theoretically receive no positive reinforcement from nicotine use," according to Dr. Naso. In pre- clinical animal studies NicVAX generated antibodies that reduced nicotine levels in the brain by up to 64 percent and blocked the effects of nicotine even at relatively high doses.
The phase I clinical trial will examine NicVAX's safety and ability to stimulate the immune system in nonsmokers. During the trial, investigators will randomly assign 20 healthy, nonsmoker adults to receive either NicVAX or a placebo injection. Safety and antibody levels against nicotine will be measured during the study. Neither the investigator nor the subject will know what was injected until the study ends.
Nabi Biopharmaceuticals has planned additional, phase II clinical trials to investigate NicVAX's safety and ability to stimulate immunity in smokers and ex-smokers. If the investigational vaccine performs well in these trials, the company will pursue definitive, phase III trials to evaluate the vaccine's efficacy to treat nicotine addiction and prevent it in people who have not yet started smoking.
At least 1.1 billion people worldwide, a third of the global adult population, use tobacco products which cause 4 million premature deaths annually, according to the World Health Organization. In the United States, tobacco use is the single leading preventable cause of death, causing more than 430,000 deaths each year and tallying an estimated $50 billion in direct medical and $47 billion in indirect non-medical costs.
Development of NicVAX is funded, in part, by grant DA13327 from the National Institute on Drug Abuse.
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