M. D. Anderson, BCM, Launch Research Effort Targeting Asthma And Allergic Diseases

A new research alliance focuses on a molecular master switch suspected of igniting the inflammatory immune response that drives asthma and other allergic diseases.

The University of Texas M. D. Anderson Cancer Center and Baylor College of Medicine have launched the Texas Medical Center Asthma and Allergic Diseases Cooperative Research Center, funded by a $5.6 million five-year grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

"We can manage asthma, but there is no cure. Finding the cause of asthma is a fundamental question in immunology," said principal investigator Yong Jun Liu, M.D., Ph.D., professor and chair of the Department of Immunology at M. D. Anderson. "The molecule we are studying, known as TSLP, appears to represent a very, very early trigger between allergens that find their way into the lungs and asthma."

"This program is focused on trying to delineate the mechanisms by which viruses and allergens are able to initiate and drive the allergic response and progression of asthma," said Dr. David Huston, professor of immunology at BCM , director of the college's Biology of Inflammation Center, and co-principal investigator. "It's probably the hottest area right now in the study of allergic diseases."

The incidence and severity of asthma, a debilitating and potentially life-threatening constriction and inflammation of the airways, has increased over the past 20 years, with more than 155 million people affected in developed countries alone.

Earlier research by Liu established that inhalation of allergens, such as pollen or viruses, sets off production of TSLP in the lining of the lungs (epithelial cells) and by specialized cells known as mast cells. TSLP then launches a molecular cascade that results in overproduction of the immune system T cell known as Th2, a known culprit in the inflammation that causes chronic asthma.

"Th2 is an important, heavily studied T cell that causes asthma," Liu said. "Our question is what induces and maintains Th2?"

By nailing down the details of this process, the investigators expect to generate new therapeutic targets for allergic disease and asthma. Liu expects drug development to begin late in the five-year grant period and extend beyond that.

The program is divided into four research efforts, starting with a project led by Huston that examines the mechanisms of TSLP expression by the epithelial and mast cells in human lungs.

Project two focuses on how TSLP then activates dendritic cells, key players in the immune system that engulf intruding antigens and present key portions of the intruder to T cells (Th2), which in turn help generate an antibody response. Li-yuan Yu-lee, Ph.D., professor of medicine at BCM, leads this project, on which Margie Moczygemba, Ph.D., assistant professor of medicine at BCM is co-investigator.

Project three, led by Liu, examines how the TSLP-generated dendritic cells in turn propagate Th2 effector and memory cells.

Project 4, led by Chen Dong, Ph.D., associate professor of immunology at M. D. Anderson, examines how inflammatory T helper cells then upregulate TSLP, perpetuating the inflammatory cycle.

Huston heads the project's clinical research core, which includes Drs. Nick Hanania, Robert Atmar, Pedro Piedra, and Robert Couch, at BCM. Liu leads the analytical and administrative cores. All four research projects also will require close interaction, Liu said.

Steve Ziegler, Ph.D., director of the Immunology Program at the Benaroya Research Institute at Virginia Mason in Seattle, is co-investigator on projects 1 and 2. Ziegler is an expert on using mouse models to understand the biology of TSLP.

Immunological research at M. D. Anderson focuses on priming the immune system to identify and attack cancer cells. Inflammation also is involved in cancer development and growth, Liu said.

"In some cancers, the microenvironment that the tumor creates around itself looks like an allergic type of inflammation," Liu said. "We need to understand this type of inflammation so we can design ways to block it in the tumor microenvironment, because it promotes tumor growth.

"While M. D. Anderson's focus is not on allergies and asthma, Dr. Huston is one of the best physicians in the country for allergic disease and has a strong research program," said Liu. "Our teams are complementary to each other's expertise. This is an exciting cooperative program and both institutions will gain from this collaboration."

In addition to several shared clinical and cancer-related research projects, this is the second major research collaboration established between M. D. Anderson and Baylor College of Medicine to study a disease other than cancer. In 2002, the two institutions formed the Bone Disease Program of Texas, which focuses on the study of osteoporosis and the treatment of bone disease.

The two institutions launched a joint neurosurgery program in June 2005, with Dr. Raymond Sawaya, M.D., chair of the of M. D. Anderson Neurosurgery Department for 15 years, also appointed chair of the Baylor College of Medicine Department.

###

Contact: Laura Madden-Fuentes of Baylor College of Medicine

Contact: Scott Merville
University of Texas M. D. Anderson Cancer Center

Impaired Sleep Quality And Allergic Rhinitis Linked

Patients with allergic rhinitis, such as that caused by hay fever and other allergies, have more difficulty sleeping and more sleep disorders than those without allergies, according to a report in the September 18 issue of Archives of Internal Medicine, a theme issue on sleep.

Allergic rhinitis, which occurs when pollen or other allergens irritate and inflame the nasal passages, affects about 20 to 50 percent of the population, according to background information in the article. Allergies have been shown to affect quality of life and several studies have suggested that they may contribute to snoring and breathing problems during sleep, including sleep apnea, a temporary halt to breathing. However, few researchers have closely examined sleep disorders in patients with allergic rhinitis.

Damien Leger, M.D., of Assistance Publique Hopitaux de Paris, and colleagues explored the association between allergic rhinitis and sleep in 591 patients (47 percent men, 53 percent women, average age 34) who had the condition for at least one year and who were being treated by an allergist or by an ear, nose and throat specialist. A control group of 502 individuals who were the same age and sex and lived in the same area, but did not have allergic rhinitis, was also assessed. In 2002, all participants reported sleep disorders and rated their sleepiness; they also provided details regarding demographics, socioeconomic status and smoking habits. For patients with allergic rhinitis, researchers recorded the type of allergies, the duration of the condition, symptoms experienced and treatments used, as well as the presence and treatment of any additional allergic disorders.

All sleep disorders and complaints--including insomnia, waking up during the night, snoring and feeling fatigued when awakening--were more common in those with allergic rhinitis, who also slept fewer hours, took longer to fall asleep and more often felt sleepy during the day. Among the 591 patients with allergic rhinitis, 41.6 percent (vs. 18.3 percent of those without allergic rhinitis) reported difficulty falling asleep, 63.2 percent said they felt they lacked adequate sleep (compared with 25.4 percent of controls) and 35.8 percent (vs. 16 percent of controls) reported insomnia. "The results show a significant impact of allergic rhinitis on all dimensions of sleep quality and, consequently, a lower quality of life as reflected by more somnolence [sleepiness]; daytime fatigue and sleepiness; and impaired memory, mood and sexuality, with a significantly increased consumption of alcohol and sedatives in cases compared with the control group," the authors write.

The effects of allergic rhinitis on sleep became more pronounced when the condition was moderate to severe. As allergies worsened, individuals slept fewer hours at night, felt sleepy more often during the day, took longer to fall asleep and found it more necessary to take sedative drugs.

All types of physicians, including primary care physicians, pulmonologists and ear, nose and throat specialists, should question patients with allergic rhinitis about their sleep habits and difficulties, the authors conclude. "This could lead to early detection and treatment of sleep disorders in these patients," they write. "Treating allergic rhinitis or other nasal symptoms may improve dramatically the quality of sleep. In the long term, such a strategy would have positive repercussions on a societal level; for example, the numbers of road and work accidents would be reduced. Considering the high incidence of allergic rhinitis and the high rate of associated sleep disorders, the issue is one of public health."

###

(Arch Intern Med. 2006;166:1744-1748.)

This study was supported by the Department of Epidemiology, GlaxoSmithKline Laboratory. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Damien Leger
JAMA and Archives Journals

ActoGenix Raises 11.5 Million Euro's In Series A Stock Financing

ActoGeniX NV, a recently founded biopharmaceutical company, announced the successful closing of its Series A financing round, raising €11.5 million (US$15 million) from a syndicate of leading life sciences investors. The transaction was co-led by GIMV (Antwerp, Belgium) and Life Sciences Partners (LSP, Amsterdam, The Netherlands), with Biotech Fund Flanders also participating. ActoGeniX is a spin-off from the Flanders Interuniversity Institute of Biotechnology (VIB) and Ghent University and was founded last June with seed capital from GIMV, VIB and individuals of the management team.

This financing will allow ActoGeniX to initiate development of a pipeline of therapeutic products based on its TopActTM technology platform. TopActTM is a proprietary delivery system comprising living non-pathogenic micro-organisms for the oral administration of biopharmaceuticals. VIB and Ghent University, the original inventors of this technology, transferred to ActoGeniX the TopActTM patent portfolio. ActoGeniX' products will address a broad range of diseases, including gastrointestinal diseases, auto-immunity, allergy and metabolic diseases. The Company's lead product for the treatment of Crohn's disease has already been successfully tested in patients.

Dr. Mark Vaeck, who joined the company as CEO, brings considerable experience in the start-up and growth of biotech businesses in Europe and the USA. In his former position, as the co-founder and CEO of Ablynx NV (Ghent, Belgium) he raised €30 million in equity financing and concluded several corporate deals with major pharmaceutical companies. Dr. Bernard Coulie joins ActoGeniX as Vice President Research & Development coming from Johnson & Johnson Europe where he held the position of Therapeutic Area Leader Internal Medicine. Dr. Lothar Steidler, the principal inventor of the TopAct technology, will become Director Technology Development at ActoGeniX.

Commenting on the financing, Mark Vaeck said: 'I am delighted with the completion of this successful financing round, which provides ActoGeniX from the start with a substantial amount of money from high-quality and knowledgeable biotech investors, which is a clear endorsement of the future potential of this company. ActoGeniX is now well-positioned to execute its ambitious business plan and quickly build a valuable portfolio of preclinical and clinical-stage products based on its proprietary TopActTM platform.'

'We have built a proprietary position around the TopAct technology and products and we are glad to be able to transfer this platform into the hands of an experienced management team, supported by highly reputed international venture capital funds' said Rudy Dekeyser, vice-general director of VIB. 'We strongly believe that Actogenix will successfully apply this platform to develop innovative therapeutics for the benefit of its shareholders and the benefit of patients worldwide.'

Patrick Van Beneden, Director Life Sciences of GIMV added: 'We see Actogenix as one of the more promising companies that recently have been started here in Flanders. The combination of world class science, experienced management and strong financial backing should be the ingredients for a life sciences company that will develop new medical treatments for large unmet medical needs like Crohn's disease and other gastrointestinal disorders.'

'We see ActoGeniX as an interesting investment opportunity in our home market based on excellent science and with broad applicability of the technology platform,' said Martijn Kleijwegt, Managing Partner of Life Sciences Partners. 'The availability of clinical data, as is the case for ActoGeniX' lead program, is something that is rarely seen in such start-up initiatives. We are excited to be part of this venture and look forward to working with the management team to make this a success.'

###

Contact: Sooike Stoops
VIB, Flanders Interuniversity Institute of Biotechnology

Food Allergies An American Obsession?

Food allergies are increasingly top-of-mind for many Americans. In fact, one out of every three people in this country claim to have a food allergy of one kind or another.* But the science doesn't support these fears. Government and medical association estimates put the actual incident rate at only between one in 25 and one in 70.

Parents are one of the groups most concerned about food allergies, especially as kids go back to school and eat more meals away from home. In many cases, they're also ill-informed about the differences between allergies and intolerances, and the proper course of treatment for each. A new survey conducted among California parents last month reveals that many are self-diagnosing food allergies and eliminating nutrient-rich foods from their child's diet without seeing a doctor first.

"Medical self-diagnosis is risky business," says Dr. Stuart Epstein, Beverly Hills Allergist, Associate Clinical Professor David Geffen UCLA School of Medicine and Cedars-Sinai Medical Center Attending Allergist. "Without professional advice, suffering is almost always extended and important foods eliminated unnecessarily."

And milk is often the "fall guy." In fact, nearly two-thirds (63%) of parents surveyed in this recent Omnibus Poll admitted to eliminating -- or limiting their children's intake -- of milk at the first sign of problems, believing dairy products to be at least partially responsible for their symptoms.

"Parents are sometimes quick to point the finger at cow's milk when their child comes down with unexplained symptoms like intestinal problems or allergic reactions," stresses Dr. Epstein. "Eliminating milk from your diet, especially a child's diet, without talking to your doctor first, is not a smart idea."

In fact, the American Academy of Pediatrics issued a statement last week urging parents not to eliminate dairy foods from their children's diet for lactose intolerance reasons. Dairy foods like milk are an important source of calcium and other nutrients that facilitate growth during a critical bone building time.

Americans often confuse food allergies with food sensitivities or intolerances. An allergy is a specific condition that involves immune response, where as an intolerance -- like lactose intolerance -- is very rare among young people. Medical experts like Dr. Epstein recommend seeking medical attention at the first sign of a problem.

From August 14th to 22nd Market Tools surveyed 551 California parents online to gauge food allergy and lactose intolerance awareness and milk allergies as a health concern for their children.

Key Findings:

- Sixty-three percent (63%) of California parents eliminate milk from their child's diet at the first sign of a food-related health issue.

- Forty percent (40%) of parents do not consult a doctor before eliminating foods from their child's diet.

About the CMPB

The California Milk Processor Board was established in 1993 to make milk more competitive and increase milk consumption in California. Awareness of GOT MILK? is over 90% nationally and it is considered one of the most important and successful campaigns in history. GOT MILK? is a federally registered trademark that has been licensed by the national dairy boards since 1995. GOT MILK? gifts and recipes can be viewed at http://www.gotmilk.com. The CMPB is funded by all California milk processors and administered by the California Department of Food and Agriculture.

-- National Institute of Health, Food Allergy Citation & Incidence Rates, pp 1-2, http://www.nih.org.

-- Paajanen L et al. Cow milk not responsible for most gastrointestinal immune-like syndromes -- evidence from a population-based study. American Journal of Clinical Nutrition. 2005; 82:1327-1235.

-- Heyman, Melvin B., M.D., M.P.H., FAAP, Lactose Intolerance in Infants, Children and Adolescents (Pediatrics, 2006;118:1279-1286).

The California Milk Processor Board
http://www.gotmilk.com

Allergy-free Cats For Sale At $3,950 Each

If you are allergic to cats, would like to have one and have $3,950 spare, this may be your lucky day. Allerca Inc., California, USA, says it has managed to breed the world's first hypoallergenic cats. People who are allergic to cats and buy one of these will not experience sneezing, red and itchy eyes or asthma - except in very acute cases.

The company says that as soon as the news got out people rushed to place orders and now there is a waiting list.

The company tested thousands of cats, looking for those tiny few that do not have glycoprotein Fel d1. Glycoprotein Fel d1 is what triggers allergic reactions in humans - it can be found in the fur, pelt, saliva, serum, urine, mucous, salivary glands, and hair roots of the cat. On finding a decent number of cats that did not carry glycoprotein Fel d1, the scientists selectively bred them.

The kittens of these selectively chosen cats do not produce human allergic reactions - they are hypoallergenic cats.

The company stressed that their cats are not the result of genetic engineering. About one in 50,000 cats do not carry Glycoprotein Fel d1 - it was a question of finding them and breeding them, there was no genetic modification.

It is estimated that about one third of all humans are allergic to cats. The market for hypoallergenic pets could be huge.

The company says its cats are friendly, playful and affectionate. They have cats in several coat colours and patterns. The coat is "medium-long, with low maintenance and minimal shedding."

Symptoms of Cat Allergy

Eyes
-- eyes become red, itchy and watery, and/or swollen

Nose
-- nose may be itchy, runny and congested, the patient may sneeze a lot

Ears
-- ears can become itchy and/or plugged (blocked)

Throat
-- nasal drip may make its way down to the throat. The throat can feel sore. The patient may often clear his/her throat. He/she may also experience hoarseness.

Skin
-- skin can be itchy, with rashes or hives

Lungs
-- patient may cough frequently, wheeze, experience tightness in the chest, shortness of breath, and often suffer from bronchitis

http://www.allerca.com

Written by: Christian Nordqvist
Editor: Medical News Today

Allergic Rhinitis Associated With Decline In Work And School Performance

Allergic rhinitis (AR), more commonly known as "hay fever" can have a profound impact on the daily lives of sufferers beyond its physical effect -- including psychological well-being, sleep quality, and ability to learn and process cognitive input, according to a new article scheduled to appear in the on-line issue of Allergy and Asthma Proceedings.

"The Burden of Allergic Rhinitis," authored by Robert A. Nathan, M.D., Clinical Professor of Medicine, Department of Internal Medicine, Division of Allergy and Immunology, University of Colorado Health Sciences Center, provides an overview of the impact of AR in our society based on findings in the landmark 2006 Allergies in America Survey (AIA) and other noteworthy surveys and studies conducted in the US and Europe. In his article, Dr. Nathan describes the negative cascade of events that adults and children can experience as a result of this condition.

"Nasal congestion profoundly affects quality of life, largely by undermining the restorative power of sleep. Poor-quality sleep leads to daytime drowsiness, fatigue, indecision and significant impairment in learning and cognition," he writes. "As a result, adults become moody, less efficient, and more likely to experience work-related injury; children are prone to be shy and may also become depressed, anxious or fearful."

Consequently, presenteeism (decreased productivity at work due to illness) and school absenteeism (habitual absence) escalate.

Lack of Effectiveness of Currently Available Intranasal Sprays

While intranasal corticosteroids are the gold standard for symptom control, patients report problems with effectiveness of currently available options. Only 16 percent of respondents in the AIA survey indicated that intranasal corticosteroids provide relief for all their symptoms, and almost half (48 percent) said they fail to provide 24-hour symptom relief.

"Patients self-adjust their use of over-the-counter and prescription products, but find that currently available options do not always provide the 24-hour relief, and if they do, there are bothersome side effects," explains Dr. Nathan. Consequently, the author concludes that there is a need for new nasal allergy medications that provide complete 24-hour symptom relief that is sustained over time.

About Allergies in America Survey

The Allergies in America survey is a landmark survey sponsored by ALTANA Pharma US, Inc. and is the largest survey ever conducted in a population of allergic rhinitis sufferers and healthcare practitioners. Analysis of the data from the 2,500 allergy sufferers and 400 physicians, nurse practitioners and physician assistants provides a window into to the behavioral and psychosocial effects of AR.

Asthma & Allergy Associates
http://www.texallergy.com/locations.htm

Model Homes Offer National IAQ Impact Results

Airborne contaminants in homes can range from allergic agents such as mold to potentially lethal threats such as carbon monoxide. Engineers at the National Institute of Standards and Technology (NIST) have developed a database of U.S. residential housing* to help conduct nationwide analyses of ventilation, air cleaning or moisture control strategies to reduce indoor air pollution.

Most people presume that the indoor air quality (IAQ) measures that rid one house of airborne contaminants should work in a similar house, but when it comes to ranking, on a regional or national scale, potentially expensive residential code or construction changes, housing and health authorities as well as homebuilders want more than conventional wisdom and supposition. They want data, and a lot of it. The new NIST set of more than 200 residential dwellings, representing 80 percent of the United States housing stock, can be combined with a computer simulation technique to determine the impacts of IAQ interventions.

NIST developed its database of model homes from the U.S. Census Bureau's American Housing Survey (AHS) and the U.S. Department of Energy's (DOE) Residential Energy Consumption Survey (RSECS). They then selected 209 dwellings as representative of 80 percent of U.S. housing stock. The homes, grouped into four categories--detached, attached, manufactured homes and apartments, were defined by their age, floor area, number of floors, foundation type and existence of a garage.

The engineers then developed floor plans for each house and created a model of each in NIST's multizone indoor air quality and ventilation assessment computer program, CONTAM. Analysts can use the models to simulate and examine energy, IAQ and human exposure issues in a particular type of dwelling or all the dwellings as a group. Conclusions drawn from simulations with a particular house type should be valid for similar houses on a nationwide or regional level. The current multizone representations of the 209 dwellings created with CONTAM are available at http://www.bfrl.nist.gov/IAQanalysis along with floorplans of the buildings. The U.S. Department of Housing and Urban Development sponsored this work.

###

*A. Persily, A. Musser and D. Leber. A collection of homes to represent the U.S. housing stock. NISTIR 7330, August 2006.

Contact: John Blair
National Institute of Standards and Technology (NIST)

GMOs And Allergies: Tests May Help Answer Questions

The potential of genetically engineered foods to cause allergic reactions in humans is a big reason for opposition to such crops. Although protocols are in place to ask questions about the allergy-causing possibilities, there has been no test that offers definitive answers.

But all of that could change as a Michigan State University researcher has developed the first animal model to test whether genetically engineered foods could cause human allergic reactions. Venu Gangur, MSU assistant professor of food science and human nutrition, has received a $447,000 grant from the Environmental Protection Agency to validate the test.

Genetically engineered crops are created by inserting a protein from a different organism into the original crop's genome. This is usually done to create a plant that is more resistant to insects or diseases.

The Food and Agriculture Organization within the World Health Organization has a structured approach to determining whether genetically engineered foods cause allergies, according to Gangur, who also is a faculty member in the National Food Safety and Toxicology Center. "But it has a major flaw. A critical question in that process asks, 'Does the protein cause an allergic reaction in animals?' The problem is that there has been no good animal model available to test this."

Gangur and students in his lab have developed a mouse model - the first of its kind - to test the allergy-causing potential of genetically engineered foods. He'll use the EPA grant to examine whether the model works on a variety of proteins. If successfully validated, the testing could be available commercially in about five years.

Perhaps the best known case of a genetically engineered crop potentially causing allergies was StarLink corn. Created by Aventis in 1996, StarLink contained the cry9C protein from a common soil bacterium, a strain of Bacillus thuringiensis. The cry9C protein protected the corn from several types of corn borers and black cutworms. StarLink was approved by the EPA for use in animal feed and nonfood products in 1998. But in 2000, fragments of cry9C DNA were detected in taco shells and other food products.

"Many people believed that StarLink was responsible for their asthma attacks and other allergic reactions," Gangur said. "The Centers for Disease Control took samples and tried to figure out if StarLink was the cause, but the data were inconclusive. There was really no good method to determine if StarLink caused allergic reactions. This is why our model will be such a valuable tool. We'll be able to determine the allergenic potential of genetically engineered crops before they're released into the human or animal food chain."

###

Robert Tempelman, MSU professor of animal science and statistics and probability, is the project's co-investigator.

Gale Strasburg, chairperson of the MSU Department of Food Science and Human Nutrition; and Jim Pestka and Maurice Bennink, MSU professors of food science and human nutrition, also are participating in the project.

The research of Gangur, Tempelman, Pestka and Bennink is supported by the Michigan Agricultural Experiment Station.

url: http://newsroom.msu.edu/site/indexer/2864/content.htm

Contact: Sue Nichols
American Society for Biochemistry and Molecular Biology

Flu Vaccine Recommended For People With Asthma

With flu season just around the corner, the American Academy of Allergy, Asthma & Immunology (AAAAI) is recommending that people with asthma and other chronic health conditions receive a flu vaccination as soon as possible.

Each year, millions of people in the United States get influenza. According to the Centers for Disease Control and Prevention (CDC), approximately 36,000 people per year in the United States die from influenza, and over 200,000 people have to be admitted to the hospital as a result of the flu.

Influenza is typically spread from person to person through coughing and sneezing via respiratory droplets. If someone with the flu coughs on you, there is a high chance you will develop flu symptoms within four days after the initial exposure to that person. Common flu symptoms include:

-- Fever
-- Muscle aches and tenderness
-- Headache
-- Fatigue
-- Dry cough
-- Sore throat
-- Runny nose

"Symptoms of influenza can be especially severe for patients with respiratory diseases, such as asthma," said Richard A. Nicklas, MD, FAAAAI, Chair of the AAAAI's Asthma Diagnosis and Treatment Interest Section. "In severe cases, influenza can cause pneumonia, may require hospitalization and sometimes can be fatal.

" Research has found that the flu vaccine decreases the risk of asthma exacerbations in patients by as much as 22% to 41%. In addition, it can also protect against acute asthma exacerbations in children. Vaccinating all children with asthma could prevent up to 78% of asthma hospitalizations and emergency room visits during influenza seasons.

The flu season usually ranges from November through March, and peaks in December, January and February. It takes approximately two weeks to develop immunity from the vaccine so it is important to get vaccinated each fall in October or November, before the flu season begins.

Contrary to popular belief, you cannot get the flu from the flu vaccine. If you feel sick with flu-like symptoms after being vaccinated, you may have caught another respiratory virus or already had the flu virus in your system when you received the vaccine.

Discuss any questions that you may have regarding influenza or the flu vaccine with your physician. For more information, visit the AAAAI Web site, http://www.aaaai.org, the Centers for Disease Control and Prevention (CDC) Web site, http://www.cdc.gov/nip/flu, or call the CDC Immunization Hot Line at (800) 232-2522.

The AAAAI's How the Allergist/Immunologist Can Help: Consultation and Referral Guidelines Citing the Evidence provide information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:

-- Need to confirm the diagnosis of asthma
-- Need education on asthma and guidance in techniques for self-management.
-- Need for daily asthma reliever medications
-- Are not using medications as prescribed, and this is limiting their ability to control their asthma
-- Have potentially fatal asthma, meaning a prior severe, life threatening episode that included intubation

To find an allergist/immunologist in your area, call the AAAAI Physician Referral and Information Line at (800) 822-2762 or visit the AAAAI Web site at http://www.aaaai.org/physref/.

The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has more than 6,000 members in the United States, Canada and 60 other countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at http://www.aaaai.org.

American Academy of Allergy, Asthma & Immunology (AAAAI)
http://www.aaaai.org

New England Journal OF MEDICINE Reports Positive Results From Dynavax' Ragweed Allergy Therapy Trial

The NEW ENGLAND JOURNAL OF MEDICINE (Vol. 355, October 5, 2006, No.14), today reported that a new approach to allergy therapy not only reduced the acute allergic responses of individuals with ragweed allergies but also sustained that effect for over 12 months. The novel treatment, called "AIC" in the paper, is a TLR9 agonist linked to ragweed allergen, developed by Dynavax Technologies Corporation (Nasdaq: DVAX).

Dr. Peter Creticos, principal investigator and lead author of the paper, entitled, "Immunotherapy with a Ragweed-Toll-like Receptor 9 Agonist Vaccine for Allergic Rhinitis," said that the pilot study "appears to offer a means of achieving long-term clinical efficacy in ragweed allergic rhinitis as the clinical effects suggest the induction of long-lasting disease modification. Furthermore, the demonstrated therapeutic properties and safety pave the way for a therapeutic intervention that is qualitatively superior to standard immunotherapy." Dr. Creticos is Associate Professor of Medicine and Clinical Director of the Division of Clinical Immunology of The Johns Hopkins University School of Medicine. He serves as Medical Director of the Johns Hopkins Asthma and Allergy Center in Baltimore, Maryland.

In the paper, Dr. Creticos pointed to statistically significant efficacy results including peak Nasal Symptom Complex Score (NSCS) reductions in AIC-treated patients of 55% (p=0.03) in 2001 which persisted through the 2002 ragweed season (53% reduction in NSCS, p=0.02) with no additional therapy. Additionally, the AIC-treated group used no relief medication at all during the second season, while placebo patients used antihistamines for 8 days (average) and decongestants for 4 days (average) of the two-week peak season. The intervention also generated clinically significant quality of life improvements for patients. Dr. Creticos added that the intervention was safely tolerated as no treatment-associated serious adverse reactions were reported, nor did any lab tests show abnormalities in the patients tested.

With funding from the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network, and the study drug provided by Dynavax, Dr. Creticos conducted a blinded, randomized, placebo-controlled, clinical trial in 25 ragweed allergic patients beginning in May 2001 and concluding in October, 2002. Patients were treated with either the drug or placebo, using a 6-injection regimen, prior to the first ragweed season, and were followed for two years. Dynavax supplied the study drug, now known as TOLAMBA(TM), and contributed to trial design, but did not participate in data accrual, analysis, or funding of the trial. TOLAMBA, consisting of a TLR9 agonist linked to a specific ragweed allergen, is currently being evaluated in late-stage clinical trials for the treatment of allergic rhinitis.

DYNAVAX Clinical Trials Update

In the paper, Dr. Creticos recommends additional large-scale studies, which are now underway at Dynavax. Since the reported study's initiation in 2001, Dynavax has generated a substantial amount of data in 14 clinical trials in the U.S., France, and Canada. More than 7,000 TOLAMBA injections have been administered to over 1,100 patients. In these trials, TOLAMBA was shown to be safe and well tolerated, to provide measurable improvements in allergy symptoms, and to reduce medication use.

TOLAMBA consists of 1018 ISS, a TLR9 agonist, linked to the purified major allergen of ragweed, called Amb a 1. The linking of ISS to Amb a 1 ensures that both ISS and ragweed allergen are presented simultaneously to the same immune cells, producing a highly specific and potent effect suppressing the Th2 cells responsible for inflammation associated with ragweed allergy. Moreover, this treatment reprograms the immune response away from the Th2 response and toward a Th1 memory response so that, upon subsequent natural exposure to the ragweed allergen, long-term protection is achieved.

Other Clinical Results; Trial Background

A Dynavax-funded, 30-center, placebo-controlled study in 738 ragweed allergic subjects, aged 18 to 55 years, is expected to produce interim data at one-year in the first quarter of 2007. The study known as "DARTT" (Dynavax Allergic Rhinitis TOLAMBA Trial) randomized subjects into three arms: the same dosing regimen that was used in the completed Phase 2/3 trial; a higher total dose regimen; and placebo. Subjects received six doses over six weeks prior to the start of the 2006 ragweed season. Ragweed symptoms were followed over the 2006 ragweed season and will also be followed through the 2007 season. The primary endpoint is reduction in total nasal symptom scores (TNSS) during the second (2007) peak ragweed season. Dynavax anticipates that data from the DARTT interim analysis, if positive, combined with the safety and efficacy data from the recently completed two-year Phase 2/3 trial, and from an ongoing trial in ragweed allergic children, could provide sufficient patient data for determining the potential timeline to registration for the intervention.

Additionally, Dynavax is evaluating TOLAMBA in a three-year, 19-center, pediatric trial with over 300 patients, ages six to 15 years. The primary endpoint of the study is reduction in TNSS during the 2006 peak ragweed season; a key secondary endpoint is the prevention of progression to asthma. The study was initiated in early 2005. Primary endpoint data for the study is expected in early 2007.

In January 2006, Dynavax announced that results from a two-year Phase 2/3 clinical trial of TOLAMBA showed that patients treated with TOLAMBA experienced a statistically significant 28.5% reduction in total nasal symptom scores (TNSS) compared to placebo-treated patients in the second year of the trial (p=0.024). Results also showed significant clinical benefit relative to secondary endpoints, including composite hay fever symptoms and ocular effects, and a significant reduction in antihistamine use (p=0.01). These results were achieved after a single short course of therapy prior to the first ragweed season (2004), and demonstrated that a booster dose prior to the second season (2005) was not required to achieve clinical benefit. The safety profile of TOLAMBA was favorable; systemic side effects were indistinguishable from placebo and local injection site tenderness was minor and transient.

TOLAMBA represents the foundation of a comprehensive allergy franchise for Dynavax, and has the potential to be a novel entrant in the multibillion- dollar global allergy market. In the U.S. alone, approximately 40 million people suffer from allergic rhinitis. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis, or 30 million Americans. Current therapeutic options are mainly limited to symptomatic therapies and conventional allergy immunotherapy, which generally requires 60-90 shots over three to five years and represents a significant treatment burden for allergy sufferers. Dynavax believes that TOLAMBA has the potential to become the first of several new and important disease-modifying therapeutic options for patients and physicians.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent allergies, infectious diseases, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: TOLAMBA, a ragweed allergy therapeutic, for which a major safety and efficacy trial (DARTT) is currently underway, and that is in a supportive clinical trial in ragweed allergic children; HEPLISAV(TM), a hepatitis B vaccine in Phase 3; and a therapy for non-Hodgkin's lymphoma in Phase 2. Its preclinical asthma and COPD programs are partnered with AstraZeneca. Funding for the company's other preclinical programs in cancer, hepatitis B and hepatitis C therapies, and for an influenza vaccine have been provided by Symphony Dynamo and NIH, and represent future partnering opportunities. Preliminary data from the study published today in the NEJM were previously reported at the AAAAI 2003 annual meeting. For more information, please visit http://www.dynavax.com.

This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our clinical development plans and timelines, business plans, future operating results, intellectual property position and potential sources of funds. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in our business, including difficulties or delays in development, achieving the objectives of our collaborative and licensing agreements and obtaining regulatory approval for our products; the scope and validity of patent protection for our products; competition from other companies; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Dynavax Technologies Corporation
http://www.dynavax.com

Ragweed Allergy Vaccine Effective For At Least One Year

A new vaccine trial has been shown to protect people from ragweed pollen allergy for at least one year, according to an article in the New England Journal of Medicine. This experimental treatment requires just six injections, once a week. Current treatments require taking several medications each day throughout the ragweed season.
Allergic reactions to plant pollens are commonly known as Hay Fever

Trial researchers said further studies have to be carried out on a larger group of volunteers.

Study author, Dr. Peter Socrates Creticos, Johns Hopkins Asthma and Allergy Center, Baltimore, USA, and team, expanded on studies that had been carried out at the University of California, San Diego, which discovered that a bacterium DNA sequence shuts down Th2 (T-helper) cell activity - an inflammatory immune system response. Th2 is commonly found to be a major factor in human allergic responses.

To create a new vaccine the team attached the DNA sequence that halts Th2 response to a portion of the ragweed pollen. Th2 cells often overreact to ragweed pollen - the new vaccine stops the Th2 from overreacting.

The Th2 cells of people who are allergic to ragweed make the body produce igE, which causes the watery eyes and sneezing. The vaccine stops the Th2 cells from sending signals which make the body produce IgE when exposed to ragweed.

The problem with current allergy medications is that they are not well targeted. Current medications have side effects because they undermine the body's immune system. This new vaccine is finely targeted - there are fewer side effects, say the researchers.

Twenty-five volunteers, aged 23-60, took part in this pilot trial,. All of them suffered from ragweed allergy. 14 were given six injections with the new vaccine, one each week consecutively. The other 11 were given a placebo injection, once a week for six weeks. Both groups started treatment before the ragweed season began.

Allergy symptoms during the ragweed season were 60% lower for the 14 who received the new vaccine, compared to the placebo group. Allergy relief continued during the next season, a year later (no additional treatment had been given).

Ragweed Allergy - Some Facts

The ragweed pollen season runs from August to November. Most areas in the USA see a peak in ragweed pollen levels in mid-September. Pollen counts tend to peak between 5am to 10am.

If you suffer from ragweed pollen allergy

-- Try to stay indoors between 5am to 10am - unless there has been some heavy rain
-- Try to keep the windows of your home and car closed
-- Avoid using fans
-- If your allergy is severe, remember that people can bring the pollen into the home on their clothing
-- Pets can bring the pollen in
-- Avoid drying your clothes by hanging them outside

Symptoms

-- eye irritation
-- inflamed, itchy nose and throat
-- puffy eyes
-- runny nose
-- sneezing
-- stuffy nose
If your allergy is more severe, symptoms may also include the following:
-- asthma attacks
-- chronic sinusitis
-- headaches
-- impaired sleep

Immunotherapy with a Ragweed-Toll-Like Receptor 9 Agonist Vaccine for Allergic Rhinitis
Peter S. Creticos, M.D., John T. Schroeder, Ph.D., Robert G. Hamilton, Ph.D., Susan L. Balcer-Whaley, M.P.H., Arouna P. Khattignavong, M.D., Robert Lindblad, M.D., Henry Li, M.D., Ph.D., Robert Coffman, Ph.D., Vicki Seyfert, Ph.D., Joseph J. Eiden, M.D., Ph.D., David Broide, M.B., Ch.B., and the Immune Tolerance Network Group
NEJM Volume 355:1445-1455 - October 5, 2006 - Number 14
Click here to see abstract online

Written by: Christian Nordqvist
Editor: Medical News Today

Allergy Sufferers Offered Longer Relief With Fewer Shots Using Experimental Ragweed Therapy

Americans accustomed to the seasonal misery of sneezing, runny noses and itchy, watery eyes caused by ragweed pollen might one day benefit from an experimental allergy treatment that not only requires fewer injections than standard immunotherapy, but leads to a marked reduction in symptoms that persists for at least a year after therapy has stopped, according to a new study in the October 5 issue of i The New England Journal of Medicine (NEJM). The research was sponsored by the Immune Tolerance Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both components of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation International.

"As many as 40 million Americans suffer from seasonal allergies caused by airborne pollens produced by grasses, trees and weeds," says NIH Director Elias A. Zerhouni, M.D. "Finding new therapies for allergy sufferers is certainly an important research goal."

"This innovative research holds great promise for helping people with allergies," says NIAID Director Anthony S. Fauci, M.D. "A short course of immunotherapy that reduces allergic symptoms over an extended period of time will significantly improve the quality of life for many people."

Ragweed is one of the most common pollens in the United States and is prevalent in the Northeast, Midwest and the South. In Baltimore, where the NEJM study was conducted, the ragweed pollen season lasts from mid-August to October.

Physicians treat people suffering from mild and moderate ragweed allergies with antihistamines or nasal corticosteroids. However, when people with allergies do not respond to these treatments or experience severe symptoms, the next therapeutic option is a course of subcutaneous injections of the allergen, which is called allergen immunotherapy. Although this standard immunotherapy is often effective, it has two major drawbacks. First, it can cause systemic allergic reactions, such as anaphylaxis, a hypersensitivity reaction that can lead to severe and sometimes life-threatening physical symptoms. Second, to provide long-lasting relief, standard immunotherapy may require frequent injections over a 3- to 5-year period. The large number of injections over such an extended period of time often results in many people not completing the treatment.

In the study detailed in NEJM, lead investigator Peter Creticos, M.D., medical director of the Johns Hopkins Asthma and Allergy Center in Baltimore, and his research team found that an investigational therapy based on the major ragweed allergen, Amb a 1, coupled to a unique short, synthetic sequence of DNA that stimulates the immune system, reduced allergy symptoms in adults for at least one year when given just once a week over a 6-week period. The therapeutic agent was provided by Dynavax Technologies Corp., based in Berkeley, CA.

"For almost 100 years, we've been using the tedious process of giving allergy sufferers one to two shots a week for up to 4 to 5 years to ensure its success," Dr. Creticos says. "This study is an important immunotherapy advance in that we've shown you can induce long-lasting relief from allergic rhinitis with just a few weeks of injections."

The study initially involved 25 adult volunteers, ages 23 to 60, with a history of seasonal allergic rhinitis, positive skin test reactions to ragweed pollen, and an immediate reaction when nasally challenged with ragweed. Prior to the start of the 2001 fall ragweed season, the study participants received six injections, each a week apart, of either the investigational therapy in increasingly higher doses or a placebo. They received no other injections throughout the course of the study. Fourteen volunteers received the study drug; 11 were given the placebo. The therapy was well-tolerated and caused only limited local reactions, which required neither medication nor change in treatment dose. No clinically significant, therapy-related adverse events occurred.

Throughout the 2001 and 2002 ragweed seasons, the volunteers were monitored for allergy-related symptoms, including the number of sneezes and the degree of post-nasal drip, allergy medication use and quality-of-life scores. Compared with the placebo recipients, the group that received the therapy experienced dramatically better outcomes that continued throughout the 2002 ragweed season even though therapy ended one year earlier.

Clearly, the regimen of only six injections showed therapeutic promise when compared with the current therapy, the study authors note. However, because the results are based on a small number of volunteers and the long-term safety of the therapy is unknown, they say additional clinical trials with longer-term follow-up to adequately assess the therapy's safety and effectiveness are necessary.

How the experimental therapy relieves ragweed allergy symptoms is not fully understood at this time. When exposed to ragweed pollen, people who are allergic to ragweed experience an increase in IgE (immunoglobulin) antibodies; immunotherapy blocks this increase in IgE. Researchers believe the experimental therapy tempers the release of immune regulatory proteins called cytokines, which blocks increases in the level of IgE antibodies.

"Using ragweed as a model allergen system with a predictable seasonal pattern of symptoms and pollen counts, it is possible to correlate pollen levels with symptoms and measure treatment effects on symptoms. This enables us to better understand immune response to allergens and serves as an approach to similar therapies to manage other allergic reactions for which there are currently no treatments, such as food allergies," says Marshall Plaut, M.D., chief of the Allergic Mechanisms Section of NIAID's Division of Allergy, Immunology and Transplantation.

###

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

Reference: PS Creticos et al. Immunotherapy with a ragweed-TLR9 agonist vaccine for allergic rhinitis. The New England Journal of Medicine DOI: 10.1056/NEJMoa052196 (2006).

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

Contact: Kathy Stover
NIH/National Institute of Allergy and Infectious Diseases

EU Health Research Must Prioritise Allergies

European public health experts are concerned because "allergic diseases" in all their different aspects - from hay fever to fatal attacks of asthma or reactions to peanuts - are not included in the health priorities of the EU research programme. While allergies are mentioned among the food research priorities, the absence of wider allergy problem as a top concern in health research agenda threatens to comprise overall progress in the understanding of this complex condition.

  Paul van Cauwenberge, Coordinator of GAІLEN (Global Allergy and Asthma European Network), says that if the European Union does not make it a top concern in health research, researchers and practitioners may fail to contain the allergy epidemic. (1)

  "GAІLEN has helped to demonstrate the magnitude of this public health problem and begun to find the solutions," says Prof. van Cauwenberge of the University of Ghent, Belgium. "But if allergic diseases are not included as a health priority in the next EU framework programme FP7 (2), we are much less likely to build the overall understanding we need to help control this epidemic through effective prevention and treatment." (2)

  While allergy experts welcomed the fact that allergy was considered under the food safety programme in the FP6, they point out that only 8% of allergies in Europe are related to food. Allergic diseases represent a "global" problem in the sense that it has multiple presentations and causes, both genetic and environmental. All the different aspects of the condition and its triggers must be addressed to gain a comprehensive understanding of allergic diseases as a whole.

  Prof. van Cauwenberge believes that politicians and different authorities would want to be alerted to the absence of the overall allergy and asthma problem within the research agenda. "If Europe does not continue to make major investments into integrating and co-ordinating research for an overall vision, we are unlikely to get to grips with why the rapid increase in prevalence is occurring, nor to be able to identify and introduce into clinical practice the best ways to prevent and manage the problem," he says. 

  Allergic diseases are taking lives daily and creating huge financial costs. According to the World Health Organization, asthma kills someone in Europe every hour. (3) One child in three is allergic today and by 2015, half of the European population may be suffering from one or more allergic condition. (4)

  Estimates have put the financial costs of allergic diseases in Europe at up to 100 billion Euros per year. (4) The personal costs fall particularly heavily on families. Parental fears of a serious attack create anxiety, and even with mild allergies family activities may be limited. Children miss days at school and abstain from sport and other recreational activities. Breathing problems and skin rashes can also harm the self-image of young children, adults and especially teenagers. (5)

  The GAІLEN network has successfully brought together 26 "centres of excellence" in allergies spread through different European countries with the aim to advance the diagnosis, prevention and treatment of allergic diseases. European researchers and doctors involved are now using standardised skin-prick allergy tests so that Europe-wide comparative analysis can take place. In the last few months, a huge European database of comparable longitudinal epidemiological studies, known as birth cohorts, has been finalised so that significantly more reliable analysis can now be made of the multiple genetic and environmental factors causing allergies.

  Working with partner organizations representing allergy specialists and patients' groups (1), GAІLEN is developing evidence-based guidelines for health professionals and the patients to help them preventing and managing the disease. GAІLEN urges policy makers to support the European Parliament proposal to include allergic diseases in the health priorities of the 7th research framework programme.

  1. GAІLEN - the Global Allergy and Asthma European Network is a "Network of Excellence" funded by the European Union 6th Research Framework Programme. It consists of 26 research centres spread throughout Europe, as well as the European Academy of Allergology and Clinical Immunology (EAACI) and the European Federation of Allergy and Airways Diseases Patients Associations (EFA). More than 30 collaborating centres have joined the network since its launch in 2004.

2. The European Union's next research programme, known as the Seventh Framework Programme Seven (FP7), begins next year and will run for seven years until 2013.  

3. World Health Report 2003, "Shaping the Future". World Health Organization.

4. "Allergy: An epidemic that must be stopped", Position Paper, European Academy of Allergology and Clinical Immunology (EAACI). http://www.efanet.org/activities/eu_policy.html

5. "EU 7th Framework Programme for Research", Position Paper, European Federation of Allergy and Airways Diseases Patients Associations (EFA). http://www.efanet.org/activities/eu_policy.html

GAІLEN - the Global Allergy and Asthma European Network

http://www.ga2len.net

Children Of Allergy Sufferers Prone To Same Problem

Infants whose parents have allergies that produce symptoms like wheezing, asthma, hay fever or hives risk developing allergic sensitization much earlier in life than previously reported, according to a study by Cincinnati researchers.

The study suggests that the current practice of avoiding skin testing for airborne allergens before age 4 or 5 should be reconsidered, so children in this high-risk group can be detected early and monitored for the possibility of later allergic respiratory disease.

Produced by scientists in UC's departments of environmental health and internal medicine and at Cincinnati Children's Hospital Medical Center, the study is reported in the October 2006 edition of The Journal of Pediatrics.

The Cincinnati researchers collected data on 680 children being evaluated for enrollment in the Cincinnati Childhood Allergy and Air Pollution Study (CCAAPS), sponsored by the National Institute of Environmental Health Sciences (NIEHS), and compared their results with findings in a 2004 Swedish study.

Using the skin-prick allergy test, the Swedish group found that in their general population - which included children whose parents did not suffer from allergies - 7 percent had allergic sensitivity at age 1. The Swedes tested five allergens, two of which were food allergens.

The Cincinnati results, however, showed that 28.4 percent of infants born to “atopic” parents, defined as those with allergies, were sensitized to one or more airborne or food allergens. Eighteen percent were positive to one or more airborne allergens, and 13.7 percent were positive only to an airborne allergen.

According to UC epidemiologist Grace LeMasters, PhD, principal investigator for CCAAPS and the lead author of the report, the Cincinnati findings suggest that the potential for allergic disorders in infancy is underemphasized, "even though sensitization to allergens at younger ages has been shown to be more important than sensitization in late childhood for the development of wheezing symptoms and asthma."

Working with LeMasters on the study were David Bernstein, MD, Jocelyn Biagini, James Lockey, MD, Patrick Ryan, Manuel Villareal, MD, all UC, and Gurjit Khurana Hershey, MD, PhD, Cincinnati Children's.

Contact: Amanda Harper
University of Cincinnati

Food Allergies Could Be Fought With Friendly Bacteria In Alcoholic Milkshake

Feeding babies alcoholic milk may help to protect against some food allergies. Kefir, a traditional fermented drink, is consumed in Eastern Europe as a health food, and is often used to wean babies, as it is easily digested. Food allergy prevalence is especially high in children under the age of three, with around 5-8% of infants at risk. Currently the only treatment is avoidance of the problematic food.

"Friendly" bacteria in kefir may play a role in blocking the pathway involved in allergic responses, Lisa Richards reports in Chemistry & Industry, SCI's fortnightly magazine. Research published 16 October 2006(DOI 10.1002/jsfa2469) in the SCI's Journal of the Science of Food and Agriculture has shown that the milk drink inhibits the allergen specific antibody Immunoglobulin E (IgE). IgE is involved in immune responses to inactivate organisms that might cause disease. However, in the presence of allergens it can also activate cells responsible for the release of histamine, a chemical which stimulates allergic responses, such as inflammation and constriction of airways.

Ji-Ruei Liu's team of scientists at the National Formosa University, Yunlin, Taiwan, fed mice the milky drink, and found that after 3 weeks, the amount of ovalbumin (OVA) specific IgE was reduced three-fold. Ovalbumin is an allergenic protein found in egg whites, which cause most allergies in young children. Kefir is also reported to prevent food antigens from passing through the intestinal wall.

Liu believes that the milky drink could be a promising tool in the prevention of allergies. "In the future, maybe we can screen out the certain components (bacterial strains or bioactive peptides) from kefir and utilize them in medicine," he said.

Also in this weeks Chemistry & Industry, UK firm Rigest are looking for backers to develop an air sanitizing system using an enzyme found naturally in human tears. Lactoperoxidase can attack and kill microbes such as 'flu viruses and the bacteria responsible for MRSA. The system could be used to sanitize the air in airplanes and hospital sick bays.

###

Chemistry & Industrybr> Please acknowledge Chemistry & Industry as the source of these items. If publishing online, please include a hyperlink to http://www.chemind.org/ Please note Chemistry & Industry uses '&' in its title, please do not correct to 'and'.

About Chemistry & Industry
Chemistry & Industry magazine from SCI delivers news and comment from the interface between science and business. As well as covering industry and science, it focuses on developments that will be of significant commercial interest in five- to ten-years time. Published twice-monthly and free to SCI Members, it also carries authoritative features and reviews. Opinion-formers worldwide respect Chemistry & Industry for its independent insight.

Journal of the Science of Food and Agriculture
About the Journal of the Science of Food and Agriculture The Journal of the Science of Food and Agriculture (JSFA) publishes peer-reviewed original research and critical reviews in these areas, with particular emphasis on interdisciplinary studies at the agriculture/food interface. This international journal covers fundamental and applied research.

JSFA is an SCI journal, published by John Wiley & Sons, on behalf of the Society of Chemical Industry, and is available in print (ISSN: 0022-5142) and online (ISSN: 1097-0010) via Wiley InterScience http://www.interscience.wiley.com/ For further information about the journal go to http://interscience.wiley.com/jsfa

About SCI
SCI is a unique international forum where science meets business on independent, impartial ground. Anyone can join, and the Society offers a chance to share information between sectors as diverse as food and agriculture, pharmaceuticals, biotechnology, environmental science and safety. As well as publishing new research and running events, SCI has a growing database of member specialists who can give background information on a wide range of scientific issues. Originally established in 1881, SCI is a registered charity with members in over 70 countries.

About Wiley
John Wiley & Sons, Ltd., based in Chichester, England, is the largest subsidiary of John Wiley & Sons, Inc. Founded in 1807, John Wiley & Sons, Inc., provides must-have content and services to customers worldwide. Their core businesses include scientific, technical, and medical journals, encyclopedias, books, and online products and services; professional and consumer books and subscription services; and educational materials for undergraduate and graduate students and lifelong learners. Wiley has publishing, marketing, and distribution centres in the United States, Canada, Europe, Asia, and Australia. The company is listed on the New York Stock Exchange under the symbols JWa and JWb. Wiley's recently re-launched Internet site can be accessed at http://www.wileyeurope.com/

Contact: SCI Press Office
Society of Chemical Industry

FDA Approves Allegra(R) (fexofenadine Hydrochloride) Oral Suspension For Treatment Of Seasonal Allergy Symptoms And Chronic Idiopathic Urticaria

Sanofi-aventis U.S. (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Allegra(R) (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy treatment option that is non-impairing to pediatric populations as young as 2 years old.

"Until now, parents had few seasonal antihistamine treatment options that were not associated with cognitively impairing adverse side effects," says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego. "However, with Allegra Oral Suspension, which does not cause sedation at any dose and is well-established for its antihistamine activity, a medication is now available in a good tasting, easy-to-swallow formulation that can help reduce the seasonal allergy symptoms of children."

Seasonal allergic rhinitis is a common chronic condition in children. Symptoms of seasonal allergies include nasal drainage, sneezing, watery eyes and itchy nose, eyes and throat. Studies indicate that seasonal allergy inflammation as well as the impairing side effects of older antihistamines can be disruptive to a child and may affect cognitive skills and function.

Allegra Oral Suspension has also been approved for the treatment of chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric patients 6 months to 2 years of age. CIU is a rare and bothersome condition characterized by hives lasting more than 6 weeks from an unknown cause. Its symptoms are caused by a reaction to an unknown trigger in the upper layers of the skin. The condition itself may cause severe itching, but is made worse by scratching.

Allegra Oral Suspension will have a berry flavor* and is expected to be available to consumers in time for the 2007 spring allergy season.

Artificial raspberry-cream flavoring

Important Safety Information

Side effects in children 6 months to 5 years old were similar to placebo. Side effects varied by age. The most commonly reported side effects were: vomiting, pyrexia, cough, otitis media and diarrhea.

Please see full prescribing information for Allegra Oral Suspension at http://products.sanofi-aventis.us/allegra_oral/allegra.pdf.

About sanofi-aventis

Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.

sanofi-aventis
http://www.sanofi-aventis.com

About 700,000 People Each Year Seek Care In Emergency Departments For Adverse Supplement And Drug Reactions, Study Says

Adverse reactions to some of the most commonly prescribed medications result in more than 700,000 emergency department visits annually, according to a study published on Wednesday in the Journal of the American Medical Association, the AP/Washington Times reports. For the study, led by CDC epidemiologist Daniel Budnitz, researchers examined data from the first two years -- 2004 to 2005 -- of a national surveillance project on outpatient medication safety developed by CDC, FDA and the Consumer Product Safety Commission. The data included information from 63 nationally representative hospitals that reported 21,298 adverse reactions to medications among ED patients. According to the study, the data, when extrapolated nationwide, indicated that adverse reactions to medications accounted for at least 701,547 ED visits (Tanner, AP/Washington Times, 10/18). The study found that the most common adverse reactions among ED patients involved accidental overdoses and allergic reactions (Ricks, Long Island Newsday, 10/18). About 17% of ED patients who experienced adverse reactions to medications required hospitalization, the study found (AP/Washington Times, 10/18). In addition, the study found:

• The medications most commonly involved in adverse reactions among ED patients were insulins used to treat diabetes; pain medications that contain opiates, such as OxyContin; and blood thinners, such as Coumadin;
  
  
• The medications most commonly involved in allergic reactions among ED patients were antibiotics that contain amoxicillin and antihistamines and other over-the-counter cold treatments (McVicar, South Florida Sun-Sentinel, 10/18); and
  
  
• Patients ages 65 and older who experienced adverse reactions to medications were twice as likely to visit EDs and seven times as likely to require hospitalization as younger patients (AP/Washington Times, 10/18).

"These are estimates just of the patients who make it" to the ED, Budnitz said, adding, "We don't even attempt to estimate the number of patients who never make it to treatment" (Long Island Newsday, 10/18).

An abstract of the study is available online.

CBS' "Evening News" on Tuesday reported on the report. The segment includes comments from Paul Watkins, professor of medicine and pharmacotherapy at the University of North Carolina-Chapel Hill, and a U.S. patient who experienced an adverse reaction to a medication (LaPook, "Evening News," CBS, 10/17).

The complete transcript of the segment is available online. The complete segment is available online in RealPlayer.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

FDA Approves Prescription Zaditor(R) For Over-The-Counter Relief From Itchy Eyes

Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved prescription Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use. An estimated 40 million Americans suffer from eye allergies. Whether in reaction to seasonal allergens including pollen and ragweed, or perennial allergens such as animal hair or pet dander, itchy eyes are a main complaint.

While most OTC products provide only 3-4 hours of short-term relief, Zaditor's full prescription strength formula offers eye itch relief that works in minutes and lasts up to 12 hours with just one drop. This significantly reduces the number of doses required per day to keep affected eyes itch-free. In addition, Zaditor is the first OTC eye itch medication safe for use in children as young as three.

"Now for the first time, people who suffer from itchy eyes caused by allergens such as pollen or pet dander can get fast, long-acting relief over- the-counter with Zaditor," says Marion Morton, Head of the US Novartis Ophthalmics Business Unit. "Because Zaditor is now available at full prescription strength without a prescription, consumers can save time and money without sacrificing long-lasting symptom relief."

Zaditor is the only OTC drop to treat eye itch associated with pollen, ragweed, grass, animal hair and dander without the potentially negative effects of a decongestant. Many OTC eye drops contain topical decongestants, which constrict the blood vessels to reduce the appearance of redness in the eye. With regular use, these products can interfere with the eye's natural ability to regulate the blood vessels, resulting in a continued redness for a period of time after discontinuation (rebound effect). Zaditor does not contain a decongestant and may be used without risk of rebound redness.

"The availability of Zaditor without a prescription greatly improves treatment options for eye itch sufferers," said Jane MacEnroe, MD, Associate Director, Medical Information and Communication, Novartis Ophthalmics. "For the first time, patients can get lasting relief over-the-counter without worrying about potential side-effects associated with long-term use of topical decongestants found in other OTC eye itch drops."

Triple Mechanism of Action

Zaditor is the only OTC eye itch drop with a triple-action formula to provide fast, durable efficacy at the source. It includes a:

-- Potent antihistamine that rapidly relieves itchy eyes within minutes

-- Mast cell stabilizer that provides extended relief for up to 12 hours

-- Prevents the release of chemical mediators to stop the late phase allergic reaction

Histamines, a chemical made by the body during an allergic reaction, are a primary cause of itchy eyes. Unlike most OTC drops, Zaditor blocks the histamines that cause itchy eyes and prevents the release of additional histamines, treating the source of the itch, not just the symptoms.

Approved in 1999 for prescription use, Zaditor has become a leading treatment for the temporary prevention of itchy eyes due to allergic conjunctivitis. Zaditor will be available over-the-counter in drug and chain stores nationwide beginning January 2007. It has a suggested retail price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well tolerated and any side effects are generally mild.

About Novartis Ophthalmics

Novartis Ophthalmics, a business unit of Novartis Pharmaceuticals Corporation, is a leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular allergies and other disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. Novartis products are made in Switzerland, France, the United States and Canada.

About Novartis Pharmaceuticals Corporation

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "will," or similar expressions, or by express or implied discussions regarding potential future sales of Zaditor. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Zaditor to be materially different from any future results, performance or achievements expressed or implied by such statements. Management's expectations regarding Zaditor could be affected by, among other things, competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of Zaditor clinical data, or new clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; and other risks and factors referred to in the Company's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Novartis Ophthalmics
http://www.novartis.com/

Allergy Drugs More Harmful Than Helpful For Chronic Ear Inflammation

Children who have persistent fluid in the middle ear, a condition called otitis media with effusion, are more likely to be harmed than helped by antihistamines and decongestants, a new review of studies has found.

The drugs are no better than placebo in alleviating symptoms or avoiding complications of OME and expose children to a significant risk of drug-related side effects.

"This review finds no benefit for any of the short- or long-term outcomes, including resolution of the fluid, hearing problems or the necessity of additional referral to specialists," concluded review authors led by Glenn Griffin, M.D., of Quinte West Medical Centre in Ontario, Canada. "However, treated study subjects experienced 11 percent more side effects than untreated subjects."

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

Otitis media with effusion is one of the most common conditions affecting young children, and about nine of 10 children will have OME at least once before school age. While OME usually is not painful, the presence of fluid in the middle ear can cause problems with hearing and balance.

Antihistamines and decongestants, commonly used to treat symptoms of allergies and colds, are sometimes prescribed for OME. According to the review authors, these drugs theoretically could alleviate congestion and decrease obstruction of the Eustachian tube, allowing drainage of fluid.

The reviewers pooled the results of 15 randomized controlled trials involving 1,516 children that compared antihistamines, decongestants or the combination to a placebo for otitis media with effusion.

The findings were consistently negative. Children who received decongestants alone or in combination with antihistamines were no more likely to be cured within one month than children who received a placebo. The same results were seen when children were evaluated at one to three months or after more than three months.

Likewise, for each of the other major outcomes the reviewers examined -- hearing loss, risk of recurrent OME, development of acute otitis media and the need for surgery to drain fluid from the middle ear -- the drugs performed no better than placebo. In fact, for hearing loss, there was a trend toward worse outcomes among the children who received medication.

In parallel with the consistent lack of benefit, the reviewers also found a significant risk of harm. In the six studies that evaluated side effects, 17 percent of children who received medication suffered side effects, compared with 6 percent of children who received a placebo.

The 11 percent difference in side effects means that for every nine children treated with these drugs, one would be harmed while none would benefit.

The results of this review came as no surprise to Richard Rosenfeld, M.D., director of pediatric otolaryngology at Long Island College Hospital in Brooklyn, N.Y. The real surprise, he said, is that physicians continue to prescribe these medications for a condition that in the vast majority of cases resolves on its own.

The 2004 American Academy of Pediatrics guideline for OME, for which Rosenfeld was co-chairman, recommended against the use of antihistamines and decongestants for OME based on the preponderance of harm over benefit. A 1994 guideline also found no data supporting the use of these drugs.

"There is absolutely no question that these products don't work," said Rosenfeld. "We have a very old, very consistent body of knowledge, all of which says the same thing, and yet these products are still commonly used by practicing clinicians."

According to Rosenfeld, the continuing use of these drugs despite no evidence of benefit is a classic example of the way in which mental images can trump the best research.

"Parents will say, 'My doctor gave me these medications to dry up the fluid,' or, 'If I use this, it's going to open the Eustachian tube.' Apparently that mental image is so powerful that it completely overwhelms common sense regarding the management of this disorder."

The best-documented side effects of antihistamines and decongestants are insomnia, hyperactivity, drowsiness, behavioral changes and variability in blood pressure.

"These are pretty ubiquitous and nontrivial effects that can impair a child's functioning at home and at school," said Rosenfeld. "If you're going to subject your child to any medication that has the potential for harm, there needs to be some assurance of benefit. Don't use ineffective medications just because you have nice visual images. You're better off doing nothing."

###

By Kelly Griffin, Contributing Writer Health Behavior News Service

Griffin GH, et al. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2006, Issue 4.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.

Contact: Lisa Esposito
Center for the Advancement of Health

Potential New Therapeutic Target For Asthma, Allergies And Cancer

Virginia Commonwealth University researchers have identified how a bioactive molecule involved with allergy, inflammation and cancer is transported out of mast cells, according to findings published online this week in the Proceedings of the National Academy of Sciences.

Mast cells are specialized cells that react to allergy-causing agents by releasing substances that trigger the body's allergic response, leading to conditions like asthma and hives. Among the molecules released by mast cells that participate in the allergic response is sphingosine-1-phosphate. This molecule is also implicated in cancer.

The work by the VCU investigators opens up a new approach to treating asthma, which affects about 15 million Americans and is increasing in incidence and mortality, especially among African-Americans. It also has implications for other allergic disorders and for cancer in terms of developing drugs that inhibit the transport of SIP out of cells.

Sarah Spiegel, Ph.D., professor and chair, VCU Department of Biochemistry, and colleagues reported how S1P, which also regulates many important physiological functions in cells, is transported out of mast cells. S1P is produced by all cells and secreted by some cells into the circulation where it can bind to specific S1P receptors. Until now, researchers have not known the mechanism by which S1P is transported out of cells.

"Our study shows that mast cells can use a special kind of transporter that has long been known to be used by cancer cells to push anti-cancer drugs out and help them survive the treatment," said Spiegel. "Our study is the first to establish a mechanism by which S1P can be exported out of mast cells and perhaps by cancer cells as well."

In previous research, Spiegel's team found that S1P levels are significantly elevated in fluid collected from the lungs of asthmatic patients after exposure to an allergen. Those findings led Spiegel's team to believe that mast cells could be a source of S1P. Mast cells are found in all body tissues and rapidly produce and secrete a number of inflammatory substances such as histamine and S1P when activated by an inflammatory stimulus. Spiegel said that S1P in turn amplifies allergic and inflammatory responses. Therefore, S1P secreted from mast cells can orchestrate many allergic responses, including asthma.

This work was supported by a grant from the National Institutes of Health.
The team included researchers Poulami Mitra, a Ph.D. candidate, Carole A. Oskeritzian, Ph.D., Shawn G. Payne, Ph.D., from the VCU Department of Biochemistry; Michael A. Beaven, Ph.D., a researcher with the National Heart, Lung, and Blood Institute; and Sheldon Milstien, Ph.D., a neuroscientist with the National Institute of Mental Health.

About VCU and the VCU Medical Center:
Located on two downtown campuses in Richmond, Va., Virginia Commonwealth University ranks among the top 100 universities in the country in sponsored research and enrolls 30,000 students in more than 180 certificate, undergraduate, graduate, professional and doctoral programs in the arts, sciences and humanities in 15 schools and one college. Sixty of the university's programs are unique in Virginia, and 20 graduate and professional programs have been ranked by U.S. News & World Report as among the best of their kind. MCV Hospitals, clinics and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the leading academic medical centers in the country. For more, see http://www.vcu.edu/.

Contact: Sathya Achia-Abraham
Virginia Commonwealth University

Emergency Department Visits Necessary For Large Number Of Adverse Drug Events

Each year, an estimated 700,000 persons experience adverse drug events that lead to emergency department visits, according to a study in the October 18 issue of JAMA.

Outpatient use of drug therapies in the United States is common. In 2004, 82 percent of the U.S. population reported using at least 1 prescription medication, over-the-counter medication, or dietary supplement in the previous week and 30 percent reported using 5 or more of these drugs, according to background information in the article. While these medications may offer substantial benefits, there also may be risks. Information on outpatient adverse drug events (ADEs) has been difficult to collect, but the problem is large and can be expected to increase.

Daniel S. Budnitz, M.D., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues analyzed data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES) to determine the frequency and characteristics of ADEs in the U.S. that have led to emergency department visits. The study included data from Jan. 2004 through Dec. 2005.

Over the 2-year study period, 21,298 adverse drug event cases were reported. "Based on data from a nationally representative surveillance system, we estimate that more than 700,000 patients were treated for ADEs in U.S. emergency departments annually in 2004 and 2005, and 1 of every 6 required subsequent hospital admission, transfer to another health care facility, or emergency department observation admission. Individuals aged 65 years or older were more than twice as likely to be treated in emergency departments for an ADE and nearly 7 times as likely to require hospitalization as individuals younger than 65 years. Among all patients who were hospitalized, most ADEs were due to unintentional overdoses and two-thirds of these were due to toxicity from a relatively small set of drugs for which regular monitoring is commonly required to prevent acute toxicity. Sixteen of the 18 drugs most commonly causing ADEs have been in clinical use for more than 20 years," the authors write.

Adverse drug events accounted for 2.5 percent of estimated emergency department visits for all unintentional injuries and 6.7 percent of those leading to hospitalization, and also accounted for 0.6 percent of estimated emergency department visits for all causes.

Insulins or warfarin, drugs that typically require ongoing monitoring to prevent overdose or toxicity, were implicated in 1 in every 7 estimated ADEs treated in emergency departments.

"The finding that individuals aged 65 years or older (12 percent of the U.S. population) accounted for one-quarter of ADEs overall and half of adverse events requiring hospitalization highlights the importance of directing ADE prevention efforts to this vulnerable population. Emergency department visits for ADEs in this age group were nearly as common as those for motor vehicle occupant injuries," the authors write.

"Efforts to reduce the burden of outpatient ADEs have been hampered by sparse data, except in selected health care systems or settings. Ongoing data collection in NEISS-CADES will enable more detailed examination of the epidemiology of emergency department-treated outpatient ADEs, focusing on specific patient populations, drug classes, conditions, and circumstances. Identifying appropriate measures of drug exposure and evaluating drug risks in relation to drug benefits remain important challenges in improving the quality of outpatient drug therapy," the researchers write.

###

(JAMA. 2006;296:1858-1866.)

Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Jennifer Morcone
JAMA and Archives Journals

CIMZIATM (Certolizumab Pegol) Maintained Response And Remission In Crohn's Patients Previously Treated With Infliximab

New data from a post hoc analysis of the PRECiSE clinical trial program demonstrated that the anti-TNF CIMZIATM (certolizumab pegol) maintained response and remission in patients with moderate to severe Crohn's disease, regardless of whether or not they had been previously treated with infliximab. These results build on the PRECiSE 2 study results previously presented, which showed that subcutaneous administration of CIMZIATM (certolizumab pegol), given every four weeks with an additional induction dose at week 2, demonstrated a statistically significant rate of response and remission at week 26 compared to placebo in patients responding at Week 6. CIMZIATM (certolizumab pegol) may offer an alternative to currently available therapies.

These new analyses will be presented this week at the 14th United European Gastroenterology Week (UEGW) in Berlin, Germany and the 2006 American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada, USA.

"Physicians and patients appreciate new options when dealing with diseases and symptoms that can dramatically affect their daily lives, as is the case with patients suffering from Crohn's disease," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology Chief, Section of Gastroenterology and Nutrition, University of Chicago, USA, at the ACG. "The study reinforces that there is a clear need for new therapies such as CIMZIA, to provide patients with therapeutic options to better manage their disease and improve their quality of life."

The new data, to be presented at UEGW and ACG by Professors Jean-Frederick Colombel, Department of Hepato-Gastroenterology, Claude Huriez Hospital, Lille, France and Hanauer respectively, analyzed the efficacy and tolerability of CIMZIATM (certolizumab pegol) in patients who had previously taken infliximab or not. Of those randomized at week 6, 68.7% of the infliximab-naпve patients and 44.2% of patients previously treated with infliximab achieved a clinical response, defined as ?100 point decrease in Crohn's Disease Activity Index (CDAI)1.

A similar pattern of results was observed for remission at week 26, based on a CDAI score1 < 150 points, as well as a 16 point or greater increase in the Inflammatory Bowel Disease Questionnaire2 (IBDQ) score. These results were statistically significantly different from those observed with placebo. Additionally, no significant differences were observed between the two groups in terms of either overall adverse events or serious adverse events.

"It is important to determine whether a patient's prior exposure to infliximab will affect the safety or effectiveness of newer therapies with distinct mechanisms of action," said Colombel at the UEGW meeting. "This new information suggests that CIMZIA may be an effective new option for treating Crohn's patients regardless of any previous infliximab treatment."

PRECiSE Clinical Trials Program

The PRECiSE Program, composed of four studies (PRECiSE 1, 2, 3, and 4), represents an innovative, large, comprehensive development program for CIMZIATM (certolizumab pegol) in Crohn's disease, including over 1,300 patients, with a planned follow-up phase of up to five years.

PRECiSE 1 is a unique trial in patients with active Crohn's disease - the first reported Phase III double-blind, placebo-controlled study of an anti-TNF extending to 26 weeks, in which eligible patients were randomized at study baseline without pre-selection of responders. Both co-primary endpoints were met with statistical significance.3

In the previously reported PRECiSE 2 study, patients responding at Week 6 to open-label induction therapy with CIMZIATM (certolizumab pegol) were randomized to either placebo (n=210) or CIMZIATM (certolizumab pegol) (n=215) and followed for a total of 26 weeks. In this trial, 62.8% of CIMZIATM (certolizumab pegol) patients, compared to 36.2% of placebo patients, maintained clinical response at Week 26 (p<0.001). Clinical response was defined as a ?100 point decrease in CDAI. Similarly, 47.9% of CIMZIATM (certolizumab pegol) patients were in clinical remission at week 26 compared to 28.6% on placebo (p<0.001).4 Remission was defined as CDAI < 150 points.

Serious adverse events occurred in 5.6% of CIMZIATM (certolizumab pegol) patients during the double blind phase. One case of tuberculosis, which responded well to anti-tuberculosis therapy, was observed in the CIMZIATM (certolizumab pegol) arm of the PRECiSE 2 trial. Local injection reactions were low in PRECiSE 2 (2.8%), and less frequent than seen with placebo. The percentage of patients who tested positive for auto-antibody formation at Week 26 (and were negative at baseline) was only 8.3% for anti-nuclear antibodies and 1.0% for anti-double-stranded DNA antibodies in PRECiSE 2. No cases of lupus were reported.4

PRECiSE 3 and 4 are both long-term (up to five years) open-label trials assessing the longer-term efficacy, safety and tolerability of CIMZIATM (certolizumab pegol) in patients from PRECiSE 1 and PRECiSE 2, and are currently ongoing.

New Studies Initiated

UCB continues to study the clinical profile of CIMZIATM (certolizumab pegol) in Crohn's disease. Enrollment has commenced in a new clinical trial involving 600 patients called WELCOME. The study will further examine the effects of CIMZIATM (certolizumab pegol) in patients failing or intolerant to infliximab. In addition, the MUSIC study will investigate the impact of CIMZIATM (certolizumab pegol) on endoscopic and mucosal healing, and the CONCISE trial will examine the corticosteroid-sparing effect of CIMZIATM (certolizumab pegol) in Crohn's disease.

About CIMZIATM (certolizumab pegol)

UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIATM (certolizumab pegol) in the treatment of Crohn's disease on February 28th, 2006 and on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the same indication. CIMZIATM (certolizumab pegol) is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody (TNF-alpha; Tumour Necrosis Factor), evaluated as once-monthly dosing administered subcutaneously. The engineered Fab' fragment retains the biologic potency of the original antibody without the cytotoxicity mediated by the Fc portion present in the original monoclonal antibodies. CIMZIATM (certolizumab pegol) has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.

About Crohn's Disease

Crohn's disease is a chronic, progressive and debilitating inflammatory disease of the gastrointestinal tract, most commonly affecting the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Together with ulcerative colitis, Crohn's disease belongs to the group of illnesses known as inflammatory bowel disease. Crohn's disease affects nearly one million people worldwide, including an estimated 500,000 people in the United States and a further 500,000 people in Europe4. People with Crohn's disease may suffer an ongoing cycle of "flare-up" and remission. Symptoms of the disease include persistent diarrhoea, abdominal pain, and loss of appetite/weight, fever or rectal bleeding. Severe symptoms may result in the need for surgical intervention. In an effort to provide Crohn's disease patients with disease management information and resources designed expressly with their needs in mind, UCB has launched patient Web sites in the U.S (http://www.CrohnsandMe.com) and Europe (http://www.CrohnsandMe.eu). Both are dynamic, cutting-edge Web sites focused on helping patients thoroughly understand Crohn's disease and live with it every day.

About UCB

UCB is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in 40 countries, UCB achieved revenues of Ђ 2.3 billion in 2005. With worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange.

UCB S.A.
60 Allйe de la Recherche
B-1070
Brussels
Belgium
http://www.ucbgroup.com