New Nicotine Vaccine (NicVAX)

New Nicotine Vaccine (NicVAX)

John (Gold)
Joined: 18 Dec 2008, 23:57

13 Jun 2002, 19:53 #1

As you read the following article about one of the lastest new magic cures being tested, NicVAX, consider the following points:
  • 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?
Breathe deep, hug hard, live long,
John - Freedom's Gold Club

Nabi Biopharmaceuticals Begins Human Testing
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.

http://www.prnewswire.com/cgi-bin/stori ... 5566&EDATE=
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Joel
Joined: 18 Dec 2008, 23:57

13 Jun 2002, 20:27 #2

Hello John:

I have watched for 30 years as new products and new procedures are anxiously awaited to solve the smoking problem. This one has been hyped for a while now, people being so excited by the use of advanced science to cure the world of nicotine addiction. To tell you the truth, I hold out a little more hope for this one than most of the past announcements, although this short article raises a rather troubling point.

When I first heard of its development, I thought it was going to block the ability of ALL nicotine from getting to the brain. This is saying it blocks the ability of 64% of the nicotine from reaching the brain. How is this different that people smoking 36% of their old cigarettes? We all know what kind of life this would be.

Unless they come up with a vaccine that blocks nicotine's ability to get to the brain I would not be putting a whole lot of hope in such a product helping people quit. Blocking it partially may make it harder to addict new people, as if it were given to kids. But I am not sure how many parents would be willing to immunize their children for a problem that they may not think the child will ever have. It is hard enough to get some parents to immunize children for diseases like measles and chicken pox for fears of possible complications. Again, we do not really know that this vaccine will work in real world settings.

My biggest fear with the announcement of such products is the false hope it often brings to smokers. Many hold off quitting thinking the "cure" is just around the corner. It is the same case when a news headline pops out that a cancer cure is just around the corner. Smokers read this and think to themselves they can just continue smoking, for any day now a cure will be announced to smoking or to the diseases caused by smoking--so they continue to consume cigarettes. I have been seeing such messages being delivered for 30 years now. The truth is we have not eradicated smoking or the diseases caused by it. With 400,000 people losing their life to smoking in America annually, and basically millions losing their life on a world-wide scale, tens of millions of people have died who were holding out hope for science to save their lives. How many more tens of millions will die waiting for the next magic cure?

Our Freedom members have taken the most powerful step they could have to reduce their risk of being an unwanted statistic in these figures. They have provided for themselves a solution to a problem that science has not yet been able to deliver on. They have stopped smoking and are on the path for reducing their chances of the onset of premature disease and death by simply committing to never take another puff!

Joel
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Hillbilly(Gold)
Joined: 19 Dec 2008, 00:03

13 Jun 2002, 20:30 #3

Lord Give Me Patience--RIGHT NOW!

Diet pills that let you eat anything you want. Golf clubs that give you a better swing. Shots that make you a non-smoker. Mankind will never quit trying to re-invent the wheel. Everyone wants an easy fix.

What's next, a pill to make me better looking?

If it's worth doing, it's worth doing right, and right is just don't take another puff.

Dave

I have chosen not to smoke for 1 Month 3 Weeks 5 Days 10 Hours 31 Minutes 45 Seconds. Somewhere there are 1975 extra cigarettes.
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John (Gold)
Joined: 18 Dec 2008, 23:57

13 Jun 2002, 21:11 #4

Look at the date on this article - Oct. 2000. In fact, thnis NIDA article gives more detail than the June 12, 2002 press release

Nicotine Vaccine Moves
Toward Clinical Trials
By Barbara Shine, NIDA NOTES Staff Writer
Volume 15, Number 5 - October, 2000
A new vaccine that prevents nicotine from reaching the brains of rats may offer hope for smokers trying to break their addiction. The compound, called NicVAX, may even prove useful as an inoculation against nicotine addiction, much like those that protect children from tetanus, measles, and polio.
"Some form of vaccination against nicotine would be highly useful because vaccinated individuals would not be able to get a 'kick' from the nicotine in tobacco smoke or chewing tobacco," says NIDA Director Dr. Alan I. Leshner. "If people found tobacco less rewarding, they would be less likely to continue using it. Ultimately, however, our best treatment for nicotine addiction is prevention."
NicVAX is manufactured by Nabi, a Florida-based pharmaceutical company that has NIDA grant support to conduct preclinical studies to determine whether the vaccine is toxic to animals and, then, if the compound is proven safe, clinical trials to evaluate its safety and efficacy in humans. The 4-year project begins this fall, and clinical trials are planned for 2002. Primary coinvestigators include Dr. Ali Fattom and other Nabi scientists in Rockville, Maryland, as well as the Minnesota- and Texas-based researchers who conducted the early animal studies.
Image Dr. Ali Fattom (left) and Dr. Sham Shirali of Nabi examine a flask of the nicotine preparation used to produce NicVAX. Photo by Jane Barrett, Nabi, Rockville, Maryland.
Dr. Paul Pentel and his colleagues at the Minneapolis Research Foundation and Hennepin County Research Center in Minneapolis and Dr. David Malin at the University of Houston at Clear Lake tested NicVAX with rats. Injection of NicVAX stimulated antibodies to neutralize nicotine in the blood, reducing by 65 percent the amount of nicotine that reached the animals' brains. The nicotine-specific antibodies produced by NicVAX also reduced the effects of nicotine on blood pressure and the heart.
Now NicVAX is proposed as a therapy that can enhance current treatments for nicotine addiction by helping quitting smokers resist the urge to light up. The hypothesis is that the vaccine may inhibit nicotine's "priming effect"-the phenomenon in which a formerly addicted individual experiences an increased desire to use a drug after a single exposure, which contributes to relapse. A treatment program built around NicVAX might also include supportive counseling and a medication such as bupropion (Zyban) to reduce withdrawal symptoms.
The animal studies suggest the vaccine's potential for preventing addiction in new tobacco users as well. When rats were injected simultaneously with a nicotine solution and the vaccine, the antibodies that reduced nicotine levels in the rat brains also reduced nicotine dependence. When the nicotine dosing was stop-ped, the control group, rats injected with nicotine and a placebo solution, showed significantly greater levels of dependence-measured by abstinence signs such as teeth chattering and tremors-than did the rats treated with NicVAX. Rats were exposed to nicotine at levels comparable to 10 packs of cigarettes daily for a week.
Continuing doses of nicotine do not interfere with the vaccine's ability to induce antibodies in the rats. Animals immunized with NicVAX while they were being injected with nicotine still produced nicotine-specific antibodies. Thus it may be possible to vaccinate a smoker while he or she is still using tobacco so that adequate antibodies will be in place at smoking cessation. The vaccine will continue to work during any relapse, inhibiting the pleasurable response that nicotine would otherwise cause. Further, the vaccine never enters the brain and is therefore unlikely to produce neurological side effects.
Sources
Pentel, P.R.; Malin, D.H.; Ennifar, S.; et al. A nicotine conjugate vaccine reduces nicotine distribution to brain and attenuates its behavioral and cardiovascular effects in rats. Pharmacology Biochemistry and Behavior 65(1): 191-198, 1999.[Abstract]
Hieda, Y.; Keyler, D.E.; VanDeVoort, J.T.; et al. Immunization of rats reduces nicotine distribution to brain. Psychopharmacology 143: 150-157. [Full Text]
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Rosemary (Gold)
Joined: 19 Dec 2008, 00:04

13 Jun 2002, 21:25 #5

I remember reading an article about this or a different drug that blocked dopamine. They tested it on heroin addicted mice. Once the experimental drug was admistered, the docile, drug-addicted mice were angerily banging the bar that fed them heroin. Apparently, they still wanted that heroin, it just did not have an effect on them.

For smokers, this does not sound like a magic cure to me. This drug sounds a lot like quitting cold turkey. Just no drug benefit from relapse. It may help people to quit, but I would not hold my breath until I see the long-term results. I am with Joel, its greatest benefit would seem to be in smoking prevention.

There are two things that scare me about this:
1. What about those healthy non-smokers who are getting the placebo? Are the drug makers hoping that they are full-blown smokers when this is over?
2. If long-term smokers get this vaccine, which I guess is supposed to last a life-time, and they still can't quit, will they walk around in a state of perpetual withdrawal, or won't they more likely smoke enough cigarettes to get back the 64% of the nicotine that the drug blocks?

Like I said, it does not sound like a magic cure to me.

Rosemary--Nicotine free for 4 Months 2 Days 8 Hours 54 Minutes. Cigarettes not smoked: 2447. Money saved: $611.85. Life reclaimed: 2 Wks 2 Days 23 Hrs 54 Mins 1 Sec.
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marty (gold)
Joined: 18 Dec 2008, 23:59

13 Jun 2002, 21:28 #6

Sheeesh, now they want to deprive people of the sheer fun of quitting Image

This product is not a quitting aid, as Joel points out. It's the equivalent of "cutting back" on smoking and putting people into a state of continuous withdrawal. Also, as John said, it's only going to remove the biological addiction to nicotine, it doesn't touch on the more difficult aspects of mental dependence, and triggers, and all the other crucial pieces of learning that we all know so much about.

So the only value of the product would be to stop kids starting to smoke.

But kids have to learn to live their own lives, and they have to develop self-discipline and common-sense to do that. The last thing we should be doing is drugging them out of doing something they shouldn't do. We need to be educating them not to do it, as a part of their learning and maturation process.

Marty
NOT A PUFF FOR 1 year 6 months 1 week 6 days
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improud (golder)
Joined: 19 Dec 2008, 00:00

13 Jun 2002, 23:40 #7

OH SAVE ME :((( Image
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Joel
Joined: 18 Dec 2008, 23:57

14 Jun 2002, 01:20 #8

For people anxiously waiting for the vaccine or another easy way to quit, go to our link of the Easy Way To Quit Smoking.
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BillW Gold.ffn
Joined: 18 Dec 2008, 23:59

14 Jun 2002, 01:31 #9

Like "light" cigarettes, I think this one will just make people smoke more.....

But its potentially not as bad as the "aids vaccine" being researched. With every disease but aids, if you have the antibodies in your blood you are immune. If you have aids antibodies in your blood, you are dying. Apparently the antibody for aids is needed to get the white blood cell to eat the aids virus, thereby enabling the aids virus to multiply. No antibody, no aids multiplication. So creating aids antibodies via a vaccine makes sense to me........

HOWEVER, as a techie, let me point out that smoking itself was developed by a bunch of dumb morons, none of whom had science degrees!!!!!!

BillW Four months, five days, 4 hours, 31 minutes and 53 seconds. 3755 cigarettes not smoked, saving $741.49. Life saved: 1 week, 6 days, 55 minutes.
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Joel
Joined: 18 Dec 2008, 23:57

14 Jun 2002, 02:16 #10

Hello Bill:

Actually smoking of tobacco was first practiced by Native Americans for ceremonial purposes and was probably smoked in a manner or quantity that rarely resulted in addiction. It was in fact smoked in pipe form. Actually the word tobacco was what the Native Americans gave to the pipe itself, not the plant. Somewhere around here we have a page on the history of tobacco usage--I think we last brought it up around Columbus day. I will look for it in a bit. I don't want to pass judgment on people's usage in the past though, considering for a long time it was believed by the scientists of the day that tobacco had curative powers for many diseases--from rabies to cancer. Over time these beliefs were found to be false and only after many decades did the full medical implications of tobacco usage really become realized.
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