Aradigm Corporation Reports Initial Human Data on a Novel Approach to Treatment of Tobacco Smoking Addiction Using its AERx Essence(R) Nicotine Inhaler - Nachrichten
October 25, 2007


Aradigm Corporation (Nachrichten) (OTC BB: ARDM) today presented Phase 1 trial results demonstrating that inhaling water solution of nicotine using Aradigm's AERx Essence palm-size inhaler results in very rapid absorption of nicotine into the blood stream and appears to be associated with acute reduction of craving for cigarettes. Aradigm believes these results provide the foundation for further research with the AERx Essence device as a means toward smoking cessation. These results were made public via a poster presentation by Tunde Otulana, M.D., Aradigm's Chief Medical Officer, at the National Conference on Tobacco or Health underway at the Minneapolis Convention Center.

"Tobacco smoking is a major public health problem in the United States, as it can lead to cancer, chronic obstructive pulmonary disease and cardiovascular disease. Despite enormous public health efforts and several approved treatments, the majority of smokers who try to quit are unable to give up this addiction," says Adam Wanner, M.D., Professor of Medicine, from the Division of Pulmonary and Critical Care Medicine at the University of Miami's Miller School of Medicine. The Aradigm trial results, albeit from an early stage study, point toward the possibility of using pure nicotine, without the other dangerous disease-causing constituents of tobacco smoke, for more effective cessation therapy than the existing treatments."

Aradigm's randomized, open-label, single-site Phase 1 trial evaluated arterial plasma pharmacokinetics and subjective acute cigarette craving when one of three nicotine doses (0.2mg, 0.4mg and 0.7mg) was administered to 18 adult male smokers. Blood levels of nicotine rose much more rapidly following a single-breath inhalation compared to published data on other approved nicotine delivery systems. Cravings for cigarettes were measured on a scale from 0-10 before and after dosing for up to four hours. Prior to dosing, mean craving scores were 5.5, 5.5 and 5.0, respectively, for the three doses. At five minutes following inhalation of the nicotine solution through the AERx Essence device, craving scores were reduced to 1.3, 1.7 and 1.3, respectively, and did not return to pre-dose baseline during the four hours of monitoring. Nearly all subjects reported an acute reduction in craving or an absence of craving immediately following dosing. No serious adverse reactions were reported in the study.

"Smoking researchers have believed for some time that a pure nicotine' pulmonary inhaler that would produce rapid absorption of nicotine into the blood stream, similar to that obtained from tobacco cigarette smoking, could be an important tool in the effort to reduce tobacco-induced disease," says Neal L. Benowitz, M.D., Professor of Medicine, Psychiatry and Biopharmaceutical Sciences and Chief, Division of Clinical Pharmacology at the University of California, San Francisco. Such an inhaler used instead of a cigarette would eliminate exposure to the combustion products that are primarily responsible for disease, and might be an effective smoking cessation treatment. Aradigm's inhaler in this trial appears to yield the desired nicotine pharmacokinetic profile; and the impact on the acute craving for cigarettes is also encouraging."

Aradigm is dedicated to the development of therapies for prevention and treatment of severe respiratory disease," says Igor Gonda, Ph.D., Aradigm's President and CEO. We are encouraged by these clinical findings and we will pursue potential partnerships with industry and other organizations to investigate further the utility of our nicotine inhalation technology to address a major global medical problem that is also very significantly affecting the United States.

According to the National Center for Health Statistics (NCHS), 21% of the U.S. population age 18 and above currently smokes cigarettes. The World Health Organization (WHO) estimates that 650 million people worldwide are smokers, which results in a health cost equivalent to $200 billion, $75 billion in the U.S. alone. Further, the NCHS indicates that nicotine dependence is the most common form of chemical dependence in this country. As a result, quitting tobacco use is difficult and oftentimes requires multiple attempts, as users often relapse because of withdrawal symptoms.

Source: Globalink and Nachrichten

Nicotine may help ease some of the debilitating and uncontrollable tremors and twitches caused by Parkinson's disease and its treatment, researchers said on Wednesday.

Monkeys given a nicotine-laced drink before drug treatment for Parkinson's showed a 50 percent reduction in movements associated with the treatment. They showed a 35 percent drop in the movements, known as dyskinesias, when given the drink after treatments.
The finding, to be published in the Annals of Neurology, suggests it may be possible to improve the lives of patients who have very limited options.
"It may be the only drug that is useful for reducing dyskinesias without making Parkinson's disease worse," Maryka Quik of the Parkinson's Institute and Clinical Center in Sunnyvale, California, who led the study, said in a telephone interview. . . .
"Not only is nicotine neuroprotective, it protects against L-dopa-induced dyskinesias. The two effects are exclusive," Quik said. Nicotine did not appear to interfere with the beneficial effects of L-dopa.
Her team is now working with companies that make nicotine-like drugs to work up a trial in people.
The key is probably chemical doorways into brain cells called nicotinic receptors

Source: www.tobacco.org and Reuters
Date: 2007-10-24
Author: Maggie Fox, Health And Science Editor, 996-2006
URL: http://www.reuters.com/article/healthNews/idUSN2431402020071024?feedType=RSS&feedName=healthNews

Subtitle: Smoking bans help lessen the urge to smoke by decreasing exposure to nicotine, and by 'de-normalizing' the behavior.

One reason bans help people quit is simple biology. Inhaling tobacco actually increases the number of receptors in the brain that crave nicotine.

"If you had a smoker compared to a nonsmoker and were able to do imaging study of the brain, the smoker would have billions more of the receptors in areas of the brain that have to do with pleasure and reward," says Richard Hurt, an internist who heads the Mayo Clinic's Nicotine Dependence Center.

So, removing the triggers that turn on those receptors is a good thing.

"If you're in a place where smoking is allowed, your outside world is hooked to the receptors in your brain through your senses: your sight, smell, the smoke from someone else's tobacco smoke or cigarette. That reminds the receptors about the pleasure of smoking to that individual, and that's what produces the cravings and urges to smoke," Hurt explains.

Hurt adds that bans help decrease the urge to smoke in another way: They de-normalize it.

Sources: www.tobacco.org and National Public Radio (NPR)
Date: 2007-10-25
Author: Patricia Neighmond
URL: http://www.npr.org/templates/story/story.php?storyId=15610995

With waning cigarette sales due to concerns about health, smoking bans and price increases, Philip Morris USA is staking its future in a new research center meant to develop products to reduce the risk of tobacco use.

The addition of the $350 million, 450,000-square-foot Center for Research and Technology, with its facade of large windows, nearly doubles the company's research space and gives the Richmond company's scientists and engineers one facility to collaborate on new projects.
The center, which is currently occupied by about 100 employees, will be home to 500 scientists, engineers and support staff by the end of the year. . . .

"There's no doubt in my mind that Philip Morris is at the cutting edge of finding a way to reduce the risk in cigarettes," Herzog said in an interview with The Associated Press. . . .

Herzog said the innovation is why Philip Morris broke from its competitors to endorse regulation by the Food and Drug Administration. Proposed legislation would give the FDA authority to restrict tobacco advertising, regulate warning labels and remove hazardous ingredients.

Sources: AP and www.tobacco.org
Date: 2007-10-28
Author: MICHAEL FELBERBAUM Associated Press Writer
URL: http://www.dailypress.com/news/local/virginia/dp-sou--philipmorris-res1028oct28,0,491259.story

"Eye-Opener" Major Report Analyzed 7,000 Clinical Trials And Took 5 Years To Complete

A major report cites obesity as a cancer risk factor that one co-author says causes nearly as many cancer deaths as smoking. Another co-author calls the obesity-cancer link the report demonstrates "remarkable."

The report, "Food, Nutrition, Physical Activity, and the Prevention of Cancer: a Global Perspective" is an "eye-opener," Early Show medical correspondent Dr. Emily Senay said as it was released Wednesday.

It shows that the connections between lifestyle choices and cancer risk are clearer than ever, she said.

The 500-page document, which took five years to compile, analyzed more than 7,000 clinical trials and was put together by the American Institute for Cancer Research and the World Cancer Research Fund

Source: CBS and www.tobacco.org
Date: 2007-10-31
URL: http://www.cbsnews.com/stories/2007/10/31/earlyshow/health/main3434821.shtml

NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation, as well as an aid to prevent relapses of a treated smoker.

NicVAX represents an extension of our conjugate vaccine technology that allows us to address a significant medical need. We believe that broad commercialization of NicVAX will be in conjunction with a marketing partner that has a demonstrated expertise in executing large scale sales and marketing programs because the physician audience will likely be primary care physicians and focused outside the hospital setting.

Nicotine is a small molecule that upon inhalation into the body quickly passes into the bloodstream and subsequently reaches the brain by crossing the blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine receptors, which results in the release of stimulants, such as dopamine, providing the smoker with a positive sensation, which causes addiction. NicVAX is designed to stimulate the immune system to produce antibodies that bind to nicotine in the bloodstream and prevent it from crossing the blood-brain barrier and entering the brain.

Source: www.tobacco.org and Nabi
Date: 2007-11-08
URL: http://www.nabi.com/pipeline/pipeline.php?id=3

The World Cancer Congress will provide a five-day event where delegates will participate in a milestone event in the global fight against cancer, where latest findings will be presented, reviewed and discussed.
Source: www.tobacco.org and International Union against Cancer (UICC)
Date: 2007-11-01
URL: http://www.uicc-congress08.org/Programme.html

Nicotine replacement therapy on its own â with no behavioural support - doubles the long term quit rate, say the authors of a groundbreaking new study.
The data means GPs should initiate NRT then refer smokers onto cessation clinics, rather than try and develop stop smoking services themselves, say the authors. . . .
But the new study â looking at over 5,600 smokers in the UK, France, Spain and North America, making self-initiated quit attempts â found that NRT more than doubled their chances of quitting.
Source: www.tobacco.org and Pulse (uk)
Date: 2007-11-01, info@pulsetoday.co.uk
URL: http://www.pulsetoday.co.uk/story.asp?sectioncode=35&storycode=4115656&c=2&hp=no

A new study suggests that forcing tobacco companies to cut the level of nicotine in cigarettes can help smokers shake off their addiction.

It was assumed that low nicotine cigarettes would simply encourage people to smoke more. Instead, a quarter of those taking part in the study quit smoking completely, while others reduced the number of cigarettes they smoked by more than a third.

Experts had feared a reduced nicotine strategy would be self-defeating, since increasing the numbers of cigarettes smokers would then be exposed to even greater levels of dangerous tobacco chemicals.

This is already known to occur with so called mild cigarette brands which contain normal nicotine levels, but are engineered to burn faster and have ventilation holes above the filter.

The new findings provide support for plans now under discussion in Congress to allow tobacco products to be regulated in the US in the same way as medicines.

Under the proposals, the US Food and Drink Administration (FDA) would be empowered to develop and enforce standards designed to make cigarettes safer, which could include reducing nicotine yields so that cigarettes are less addictive.

In the study, adult smokers were asked to smoke their usual brand for a week. They were then put on a six week regimen of smoking cigarettes with progressively lower levels of nicotine. At the end of the six weeks, they were free to return to their usual brand and most did. But tested a month later, they were smoking forty per cent fewer cigarettes per day than they did before the study. Furthermore, a quarter of the smokers quit their habit entirely while the study was in progress.

Professor Neal Benowitz, who led the research team from the University of California at San Francisco, said: "This study supports the idea that if tobacco companies were required to reduce the levels of nicotine in cigarette tobacco, young people who start smoking could avoid becoming addicted, and current smokers could reduce or end their smoking." Source: ASH daily news (www.ash.org.uk) and Channel 4, 14 November 2007
Link: http://tinyurl.com/2vbdze

The decades long decline in smoking by Americans has stalled for three years, the first time smoking rates have leveled off for that long since the federal government began collecting statistics more than 40 years ago.

After more than a decade of steep decline, smoking rates for high school students have not only hit a plateau in the past few years but also increased. This comes amid controversy over the targeting of young women by the R.J. Reynolds Tobacco Co. with its Camel No. 9 cigarette, which is packaged in "hot-pink fuchsia" and is advertised as "light and luscious."

Experts said that the data released by the Centers for Disease Control and Prevention presents a worrisome picture of smoking patterns, especially because the trend has been declining for such a long period.

Corinne Husten, head of the epidemiology branch of the CDC's Office on Smoking and Health said, "Anytime we are not seeing a decline, it's a cause of real concern to us. Smoking is the biggest cause of preventable disease we have, and we need to bring down the rates as quickly as we possibly can."

According to the CDC report, about 20.8 percent of American adults are smokers, with 80 percent of them smoking every day and the rest smoking on some days. Adult smoking rates declined more than 15 percent from 1997 to 2004 but have been stubbornly unchanged since.

Husten pointed to several probable reasons for the unwelcome news. Cigarette companies have been spending billions of dollars to offset tax increases and to discount their products, and funding has been cut sharply for several very successful state anti-smoking campaigns, she said.

The relatively unchanged price of cigarettes since 2002 is considered important, because more people stop smoking because of cost than for any other single reason. That is especially true of younger smokers. While some states have increased tobacco taxes, the federal government has not raised its rate for more than a decade, and President Bush has strongly opposed a congressional proposal to increase the tax to expand the State Children's Health Insurance Program.

William V. Corr, executive director of the Campaign for Tobacco-Free Kids, said the administration has been "AWOL regarding tobacco control, doing little or nothing."

The administration has also declined to send the World Health Organization's Framework Convention on Tobacco Control to the Senate for ratification. The treaty, signed by the United States in 2004, would require toughening of U.S. anti-smoking efforts. So far, more than 150 of the 168 nations that signed the treaty have ratified it, but the State Department has consistently said it is still studying the document.

Source: ASH daily news, www.ash.org.uk

After a letter asking that the butts be swept up appeared in a local newspaper, Ms. Wadsworth took action. Cleanup was imperative, but it needed to be done in an environmentally correct manner. At a village board meeting last month, she said, "Please don't sweep them away into the storm drain."

She advocated that the village set out designated waste receptacles and initiate an educational campaign.

Ms. Wadsworth, 57, a stay-at-home mother, began exploring the impact of cigarette butts and other marine debris on the Internet while helping her son, Timothy, now 17, do research for a ninth-grade class in environmental studies.

When he volunteered to do beach monitoring, she went along. . . .
The problem, he said, "is exacerbated by the fact that we are on an incline and all of our stormwater runoff takes everything into the harbor."

If the cigarette litter cannot be reduced in a neighborly fashion, he said, "then we will have to take the next step and put something in the village code." . . .

Ailene K. Rogers, a marine program educator who runs Cornell's water logging program, said Ms. Wadsworth had been diligent in raising awareness. She noted that tiny objects like cigarette butts were "insidious" and "ubiquitous" and often overlooked by litter pickers but can "cause great damage to wildlife and even boat engines."

Source: www.tobacco.org and New York Times
Date: 2007-11-04
Author: MARCELLE S. FISCHLER, lijournal@nytimes.com
URL: http://www.nytimes.com/2007/11/04/nyregion/nyregionspecial2/04peopleli.html?_r=2&oref=slogin&oref=slogin

Researchers warned that while Asian men generally have less trouble with hereditary male hair loss, smoking cigarettes may erase this advantage.
The authors of the study, Lin-Hui Su and Tony Hsiu-Hsi Chen said, "Smoking may destroy hair follicles, interfere with the way blood and hormones are circulated in the scalp or increase the production of estrogen."
"Our study of 740 men in Taiwan with an average age of 65, found cigarette use played an important role in the development of moderate or severe hair loss."
The study, published in the November issue of the Archives of Dermatology, recommended that men showing early signs of hair loss should be advised about the role smoking can play to prevent further progression.

Sources: ASH (www.ash.org.uk) and Science Daily, 19 November 2007
Link: http://tinyurl.com/254hub