New Nicotine Vaccine (NicVAX)

Joel
Joined: 18 Dec 2008, 23:57

14 Jun 2002, 19:54 #21

Hello Carl and Marty. I too see how this string can be leading into a debate over the motives of development of such a product and the literal questioning of science. We really do try to make an effort to minimize such debates, the reasons explained in our mission statement. But when new products are just being released or a new product is on the horizon and is being touted as a panacea for smoking cessation, we feel the need to put such statements in perspective.

Carl, you caught the point I was getting at when saying you would likely die if you smoked waiting for these promises of science curing smoking to come true. But for every person who understands the subtle nuance and limitations of such announcements there are many more people who just do not put this information in proper perspective.

Where I see such announcements of science being dangerous is when scientists or the news media starts giving the impression of a cure for lung cancer is just around the corner. It is true that our science is getting ever more sophisticated and one day a cure may in fact be developed. I would say that if we were looking ahead to future generations the odds are quite good. But the odds of a cure coming out soon enough to save a smoker alive today should not be counted on--we have held out high hopes for this for a long time and are still losing hundreds of thousands of people annually from this specific disease.

Even a child reading such news today should think twice and three times before taking up smoking thinking that this cure may save his or her life if he or she would take up smoking. There is a real good chance his or her smoking parents and maybe even grandparents read or heard the same kind of hopeful news reports prior to taking up smoking too.

But don't get us wrong here when we point out the limitations of this science. I do hope that the research to find such a cure is continued and that may a cure right around the corner. I know quite a few people who are alive today battling this disease and I would be thrilled if there were a cure today introduced to save their lives. But even if that day comes while I am alive I will see it as a bitter sweet victory, for while the cure may save people from that point on, there will be countless others who I will have known who would have died because the cure was just too late--and basically millions more who I didn't know who lost their lives hoping and praying for such a cure.

We want all people here to recognize what they are doing by quitting now is the best chance they currently have to lower their odds of dying of lung cancer--and a host of other diseases. Not by curing it, but by minimizing the risk of developing it.

On the same token I do hope that one day science does come out with a way to prevent smoking, whether it be by preventive measures or treatments for current smokers. But again, I am not holding out high hopes of this happening anytime soon. The promise has been dangled out there numerous times and have basically all fallen flat.

What our members are doing here and now is the best chance they have of beating the nicotine addiction. Again, not by "curing" the addiction, but by taking control of it and rendering it harmless. The only risks posed by being addicted to a substance that you no longer administer is the risk of relapse if YOU once again admininister it. The risk of this happening though is nil if you constantly enforce your vow to never allow nicotine into your body via any route such as chewing, eating, drinking, inhaling, placing on your skin for absorption, injecting and of course the most obvious and likely route, by knowing to never take another puff!

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

14 Jun 2002, 22:32 #22

NicVAX's competitor TA-NIC [/size]

06/14 09:33
Xenova Study Shows Anti-Nicotine Treatment Is Safe (Update2)
[/size]

By Craig Brett
[/size]
Slough, England, June 14 (Bloomberg) -- Xenova Group Plc Chief Executive Officer David Oxlade wants to stop people from feeling good -- for all the right reasons. His company's making treatments that take the pleasure out of nicotine and cocaine.[/size]

One of the medicines, the anti-nicotine treatment TA-NIC, was safe and well tolerated in an early study, the U.K. biotechnology company said today. The vaccine produces antibodies that successfully latch on to nicotine, Oxlade said.[/size]

``The reason nicotine is addictive is that it moves so easily from the blood to the brain, where it causes so much pleasure,'' Oxlade said in an interview. ``Antibodies in the blood mop up the nicotine and prevent it from getting to the brain.''[/size]

Eight in 10 people who quit smoking start again within a year, said Oxlade, who gave up the habit 20 years ago. The health advocacy group Action on Smoking and Health says 120,000 people in the U.K. will die of smoking-related diseases this year, and that about 450 children start smoking every day.[/size]

Xenova's anti-nicotine treatment is injected into the muscle about four or five times over a two-month period, and its effectiveness should last as long as a year, the company said.[/size]

The unprofitable company is also working on a drug to treat cocaine addiction, called TA-CD. A company study showed that rats given access to the illicit drug would increasingly administer it to themselves. TA-CD slowed that process.[/size]

Oxlade said Xenova would seek a partner to help bring the treatment to the market. It will be several years before it's available for sale.[/size]

Xenova had about 17 million pounds ($25 million) in cash at the end of March, after spending about 4 million pounds last year. The anti-nicotine treatment has finished the first of three studies generally required before receiving regulatory approval, and wouldn't reach the market for several years.[/size]

The company's shares rose 75 pence, or 1.5 percent, to 51.75p in mid-morning trading. They've lost a quarter of their value this year.[/size]
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John (Gold)
Joined: 18 Dec 2008, 23:57

05 Jul 2002, 21:42 #23

First TA-NIC Vaccine Study Results
Produce 96% Nicotine Relapse Rate

I hope that none of you ran out and bought stock in TA-NIC after reading about their wonderful new nicotine vaccine. I understand that The Wall Street Journal reported today, July 5, 2002, that .... "50 smokers in Belgium were injected with an unusual drug code-named TA-NIC. After taking as many as five doses over 10 weeks, two smokers quit. Several others reported a lower desire to smoke, according to Xenova PLC, the drug's British maker."

Unfortunately, that is a higher relapse rate than if they'd been uneducated, unskilled, unsupported and uncounseled cold turkey quitters - 10 to 12% at six months and 5 to 6% at one year Image
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John (Gold)
Joined: 18 Dec 2008, 23:57

11 Feb 2004, 22:39 #24

Smoking Has Killed
Six Million Smokers
Since NicVax
Announced Its Cure


We've each been reading magic cure stories for as long as we smoked nicotine. The traveling hypnotist guaranteed I'd quit - "90% success rate" the ad said. Maybe that's why I went back a few years later for a second try. I just couldn't believe that I was the 1 in 10 for whom this cure just didn't take. How are they still getting away with such outlandish performance assertions when all objective medical studies conducted to date have found no advantage for hypnosis?



All the games being played really don't matter. The bottom line is none of the magic cures to date have abated smoking's worldwide kill rate nor have any of them been effective in ending chemical dependency upon nicotine - none.



The below article is typical of hundreds of similar articles that have ran in newspapers around the world since we started this thread back in  June 2002. Hardly a day goes when the major tobacco news services are not reporting the story being shared somewhere. My concern is that stories such as these are junkie rationalization fuel helping carry millions of addicts to early graves.



As shown below there are new entrants and achievements in the vaccine wars but also new problems as they have absolutely no way of proving efficacy for those who've already quit as these researchers understand the "Law of Addiction" (rewritten - never take another puff!).



This thread has produced some rather interesting observations. If science is eventually able to block 100% of nicotine from crossing the blood-brain barrier but is unable to alter the intensity or duration of the physical or psychological recovery experience, how long will it take for nicotine addicts who've taken the vaccine to realize that there are a host of illegal drugs and Rx pain medications available capable of pumping out large quantities of dopamine, whose molecule is not blocked by an effective vaccine? Sound pretty far fetched? I'm not so sure.



Nicotine has long been known as the "gateway"drug. This quote is from my state's drug abuse agency:
"Many of today's youth who smoke cigarettes will become addicted to nicotine. But that's not all. Underage smokers are much more likely than non-smokers to use alcohol and other drugs. For example, underage smokers in South Carolina are:
  • three times more likely to drink alcohol;
  • seven times more likely to smoke marijuana;
  • 15 times more likely to use cocaine; and
  • 41 times more likely to use hallucinogens. "
SC DAODAS - http://www.scprevents.org...e/readroom/clearing.html
Today there is still only one way to allow the brain the time needed to re-sensitize itself to its own neurochemicals by normalizing the number of neurotransmitter receptors and transporters in a host of important circuits, and that's to stop putting nicotine into the brain. Will an effective vaccine someday protect the brain from being forced to accept a highly addictive natural insecticide that nature intended to kill bugs who try eating the tobacco plant? I don't know. What we do know is that this temporary journey of adjustment can be one of the most rewarding adventures of our life and it's ours to keep so long as we decide to Never Take Another Puff!



A vaccine against smoking

By Eran Shifferman
February 11, 2004, Haaretz News
A number of antidotes to nicotine, currently undergoing clinical trials, are designed to stimulate the body's immune system to create antibodies. These bind with nicotine molecules, forming a compound too large to traverse the blood-brain passage. The result is that the pleasurable effect of smoking is neutralized and the addiction to  nicotine prevented. The compound later breaks down into harmless components and is excreted from the body.

Three companies have produced vaccines. The Swiss firm Cytos has developed Nicotine-Qbeta. The Xenova Group in the U.K. is testing TA-NIC, in which the active ingredient is a kind of "tagging" procedure using a nicotine derivative and an endotoxin from the cholera virus. The American firm Nabi Biopharmaceuticals has developed NicVAX with an endotoxin from a different virus.

Binding with a protein stimulates the immune system to produce antibodies to nicotine, which would not have occurred had the nicotine molecules been able to move freely in the bloodstream. All the vaccines are administered by injection.

In preliminary trials, in which rats were injected with NicVAX, a 65 percent reduction in the nicotine entering the brain was observed. The San Diego-based Scripps Research Institute (TSRI) has announced that it is developing a second-generation nicotine vaccine designed to solve a problem that has vexed researchers: the nicotine molecule is flexible enough to produce structural changes, making it difficult for antibodies to bind with it. In the new version, the nicotine derivative has been engineered for stability. TSRI researchers claim that the second-generation vaccine produces a far broader immune reaction than its predecessor.

Reservations have been voiced within the medical community regarding the success of the vaccines. Some researchers wonder about nicotine addicts increasing the number of cigarettes they smoke to the point where the antibodies are unable to cope with the quantity of nicotine taken in.

In any event, the focus of the clinical trials at this stage is on the safety of the vaccine rather than on its efficacy and its ability to prevent addiction.

An additional problem is a question of ethics: the guidelines for the trials forbid giving nicotine to someone who has already been weaned off it.

Some of the biopharmaceutical companies are simultaneously working on a vaccine against cocaine. If their experiments succeed, it will provoke a social-ethical debate about the authority of society and of parents and teachers in controlling undesirable patterns of social behavior in advance. It is unlikely that anyone will object to a vaccine against cocaine, but the debate over nicotine will be interesting to watch.
© Copyright 2004 Haaretz. All rights reserved
Last edited by John (Gold) on 06 Feb 2011, 18:09, edited 1 time in total.
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Joel
Joined: 18 Dec 2008, 23:57

11 Feb 2004, 23:01 #25

The below is lifted from a post earlier in this string that discusses the same point John is making here:
From: Joel. Sent: 6/14/2002 6:54 AM
Hello Carl and Marty. I too see how this string can be leading into a debate over the motives of development of such a product and the literal questioning of science. We really do try to make an effort to minimize such debates, the reasons explained in our mission statement. But when new products are just being released or a new product is on the horizon and is being touted as a panacea for smoking cessation, we feel the need to put such statements in perspective.



Carl, you caught the point I was getting at when saying you would likely die if you smoked waiting for these promises of science curing smoking to come true. But for every person who understands the subtle nuance and limitations of such announcements there are many more people who just do not put this information in proper perspective.



Where I see such announcements of science being dangerous is when scientists or the news media starts giving the impression of a cure for lung cancer is just around the corner. It is true that our science is getting ever more sophisticated and one day a cure may in fact be developed. I would say that if we were looking ahead to future generations the odds are quite good. But the odds of a cure coming out soon enough to save a smoker alive today should not be counted on--we have held out high hopes for this for a long time and are still losing hundreds of thousands of people annually from this specific disease.




Even a child reading such news today should think twice and three times before taking up smoking thinking that this cure may save his or her life if he or she would take up smoking. There is a real good chance his or her smoking parents and maybe even grandparents read or heard the same kind of hopeful news reports prior to taking up smoking too.



But don't get us wrong here when we point out the limitations of this science. I do hope that the research to find such a cure is continued and that may a cure right around the corner. I know quite a few people who are alive today battling this disease and I would be thrilled if there were a cure today introduced to save their lives. But even if that day comes while I am alive I will see it as a bitter sweet victory, for while the cure may save people from that point on, there will be countless others who I will have known who would have died because the cure was just too late--and basically millions more who I didn't know who lost their lives hoping and praying for such a cure.




We want all people here to recognize what they are doing by quitting now is the best chance they currently have to lower their odds of dying of lung cancer--and a host of other diseases. Not by curing it, but by minimizing the risk of developing it.


On the same token I do hope that one day science does come out with a way to prevent smoking, whether it be by preventive measures or treatments for current smokers. But again, I am not holding out high hopes of this happening anytime soon. The promise has been dangled out there numerous times and have basically all fallen flat.



What our members are doing here and now is the best chance they have of beating the nicotine addiction. Again, not by "curing" the addiction, but by taking control of it and rendering it harmless. The only risks posed by being addicted to a substance that you no longer administer is the risk of relapse if YOU once again admininister it. The risk of this happening though is nil if you constantly enforce your vow to never allow nicotine into your body via any route such as chewing, eating, drinking, inhaling, placing on your skin for absorption, injecting and of course the most obvious and likely route, by knowing to never take another puff!




Joel
Last edited by Joel on 06 Feb 2011, 18:12, edited 1 time in total.
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John (Gold)
Joined: 18 Dec 2008, 23:57

29 Sep 2004, 22:33 #26

Canada.com
CBS Market Watch
Reuters.co.uk
As stated in above articles, yesterday Nabi asserted to the world that "a Phase II clinical trial showed that 33 percent of 68 smokers inoculated with the company's NicVax vaccine were able to quit, as opposed to 9 percent who took a placebo." "The company did not say how long the smokers remained smoke-free. Nabi said it will release full Phase II clinical trial results at various scientific meetings in 2005."
Nabi's press release intentionally omits some rather critical info:
  • How long they quit - a week, a month, three months, six months?
  • How quitting was defined - continuous nicotine cessation, point prevalence or some new creative definition?
  • What behavioral interventions, counseling and/or support were used (if any), that had their own proven effectiveness and for which NicVax should not be allowed to claim credit?
  • What are the results of the study's blinding assessment?
  • What happened to the 66% who relapsed with the vaccine still inside them - has their daily smoking actually increased?
What's most frightening is that we knew from the Phase I study that one-third of the nicotine smoked was not binding with the vaccine which we are told would have made the new molecule too large to pass through the blood brain barrier. In other words, we knew that a relapsed smoker would need to smoke roughly three times their old nicotine intake in order to have sufficient nicotine present in the brain to satisfy their old level of tolerance.
As for blinding, we just learned that a $1.4 billion dollar NRT industry has likely been built entirely upon junk science in that the studies were not blind as claimed (see - http://whyquit.com/pr/051904.html). If true, why would a psychoactive chemical (nicotine) not also be psychoactive in vaccine studies?
What are the odds that a substantial percentage of those assigned to receive the placebo in the NicVax studies remained blind to the fact that within 8 to 10 seconds of that first puff, a big big "aaahhh" sensation still arrived? Think about it. If they had joined the study in hopes of receiving this new miracle cure then what are the odds that they would have remained in the study once their expectations were dashed?
It's a bit different from realizing that they were not experiencing their dopamine/adrenaline high, as in the NRT studies, but the drug is still psychoactive and researchers in both study areas must come to terms that relying upon frustrated expectations to produce victories is not science but more closely akin to outright fraud. Frankly, I'm beginning to believe that it may be impossible to use a placebo study format when dealing with any psychoactive chemical.
Yes, thirty-three (33%) percent is a solid recovery rate but only when put in an honest and comparable context. I am light years away from having the recovery understanding of Joel in helping educate and a group of quitters yet I have yet to do a quit smoking clinic where at least 50% of participants were not still nicotine-free at two weeks. Although it has been some time science we've done an evaluation here at Freedom, our last two evals produced 38 and 39% six month continuous nicotine cessation rates for new members posting to the group at least once.
We are not limited to just analyzing the active NicVax group (those receiving the vaccome either, as we know that roughly 10% of the placebo group should have successfully quit smoking for months if they had quit entirely on their own without any products, procedures or programs (see http://whyquit.com/whyquit/A_OTCPatch.html ). If the 9% in the Nabi study was for a period shorter than 6 months, or if counseling or group support was used as part of the study (both of which produce effectiveness in their own right) then it would seem to suggest that the placebo group may have sustained some degree of expectations defeat.
The NicVax study press releases have generally been less than forthright, omitting substantial detail that would have allowed smokers to better evaluate the vaccine's merits, if any. It is my guess that a creative definition of quitting is being employed. Why? Well, the very foundation of a vaccine is that it inoculates the user against risks posed by a known harm. If a smoker now believes that they can smoke nicotine but that the nicotine will not enter their brain then shouldn't we expect some precentage to try and test or challenge the vaccine now and then?
If so, wow do we come up with a quitting definition that will allow them to do so yet also allow the researchers to proclaim to the world that they quit? In NRT studies many researchers employed a quitting definition called "point prevalence" which only asked if the quitter had quit smoking during a particular time period, almost always the "point" in time -- and a stated number of days preceding -- when they were scheduled to have their next appointment at the study center for a quitting evaluation, an event which many studies paid participants financial compensation.
As you know, the NRT studies actually invented their own creative definition of quitting. No longer was continuing to be hooked on nicotine a concern as up to 7% of gum users still dependent upon the gum at six month were declared to have successfully quit. Now that science was able to extract nicotine from the tobacco plant and put it into new and creative delivery devices, for the very first time quitting smoking no longer required the addict to quit nicotine too.
What is troubling about past vaccine press releases is that they vastly over-inflated expectations. We each know that thousands of junkie minds are searching for a way to rationalize continued smoking. Those who attempt to convince them that a cure is just a few years away may actually be contributing to helping cost thousands their health and quality of life or, worse yet, life itself.
Overall the vaccine researchers have been extremely irresponsible by not telling nicotine addicts not to wait on "possibilities" but to quit now and quit today. I get mad at myself for even thinking such thoughts but with certain stories I was left with a deep hurt upon feeling that they almost wanted smokers to delay cessation.
After ten days to two weeks nicotine dependency recovery is almost entirely psychological. Pharmacology continues to all but ignore this reality. It would be fantastic if we could safely inoculate the world's children against nicotine addiction but don't hold your breath as it is not happening here.
Still only one rule for me as well as you, no nicotine just one day at a time ... Never Take Another Puff! John (Gold x5)
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John (Gold)
Joined: 18 Dec 2008, 23:57

04 Mar 2005, 21:09 #27

TA-NIC 12 Month Results Disturbing
The below TA-NIC press release presents far more questions than answers. Here are a few of mine.
1. If only one-third of nicotine smoked is able to pass the blood brain barrier once the "vaccine" is taken, what change in the number of cigarettes smoked per day has occurred to the 81% of 250 ug TA NIC users who reported relapse?
2. Why would a study as scientic as this rely upon the honor system and "self reporting" by participants instead of conducting either expried carbon monoxide or blood or urine cotinine testing?
3. What safety concerns caused Xenova to abandon the higher performance results from the 1000 ug group? Why not share them?
4. Why did this press release fail to report the 50ug results?
5. Has the Xenova Group dedicated sufficient resources toward long-term health effects follow-up for 100% of participants who've taken the "vaccine?"
John

News Release


Xenova Group plc
Anti-Smoking Vaccine TA-NIC
Preliminary 12 Month Clinical Trial Results
Slough, UK, 3 March 2005 -
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squirrelgirl01
Joined: 19 Dec 2008, 00:03

04 Mar 2005, 21:15 #28

I've heard it all, gee...what's next?

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

13 Dec 2005, 01:15 #29


Reduced nicotine distribution from mother to fetal brain in rats vaccinated against nicotine: time course and influence of nicotine dosing regimen.
Biochemical Pharmacology, May 2005, 1;69(9): pages1385-1395.


Keyler DE, Dufek MB, Calvin AD, Bramwell TJ, LeSage MG, Raphael DE, Ross CA, Le CT, Pentel PR.

Minneapolis Medical Research Foundation, Hennepin County Medical Center, Minneapolis, MN 55415, USA.

Nicotine is a teratogen in rats and possibly in humans. Vaccination against nicotine is being studied as a possible treatment for nicotine dependence. The safety of maternal vaccination against nicotine during or prior to pregnancy is not known. In this study, female rats were vaccinated and then administered acute or chronic nicotine during pregnancy at doses simulating nicotine exposure in smokers.
Maternal vaccination reduced nicotine distribution to both maternal brain (44-47%) and fetal brain (17-39%) for up to 25 min after a single maternal nicotine dose administered on gestational day (GD) 20, but had a smaller effect on nicotine distribution to brain after continuous nicotine infusion.
Nicotine distribution to maternal or fetal brain after repeated nicotine bolus doses was reduced immediately following an individual dose in vaccinated rats, but the chronic accumulation of nicotine in fetal brain was not altered. Nicotine distribution to whole fetus, in contrast to fetal brain, was generally not altered by vaccination. Nicotine-specific antibody concentration in fetal serum was 10% that of maternal serum, and in fetal brain was <1% of maternal serum.
Although nicotine transfer to the whole fetus was not reduced by vaccination, protein binding data suggest that nicotine-specific antibody transferred from mother to fetus served to bind nicotine in fetal serum, reduce the unbound nicotine concentration, and thereby reduce nicotine distribution to fetal brain. These data comment on the safety of vaccination against nicotine during pregnancy, and suggest that vaccination may reduce the distribution of nicotine to fetal brain under some nicotine dosing conditions.

PMID: 15826609 [PubMed - indexed for MEDLINE]
Source link:
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JoeJFree Gold
Joined: 18 Dec 2008, 23:57

13 Dec 2005, 01:29 #30

John,

If I read this correctly the results point to some limited effectiveness with the nicotine blocking vaccine. Certainly not a total solution or unqualified success.

I wonder why a more holistic solution is not considered. Instead of adding another drug or agent to a person's blood chemistry, who not remove the chemical that is not suppoed to be there to begin with?

Becoming and staying nicotine free IS an expedient and available option for all who choose to live as the were meant to be. Naturally.
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