Showing posts with label Asthma. Show all posts
Showing posts with label Asthma. Show all posts

May 7, 2007

New Children's Claritin(R) Grape Chewables Provide Non-Jittery, Non-Drowsy, All Day Relief For Kids' Allergy Symptoms

Helping young kids relieve their allergies during the busy back-to-school season just got easier. Schering-Plough Corporation (NYSE: SGP) today announced the introduction of CHILDREN'S CLARITIN(R) Grape Chewables, a pleasant-tasting, convenient and easy-to-take form of CHILDREN'S CLARITIN that relieves kids' worst allergy symptoms without causing jitteriness or drowsiness so they can focus on their school work -- not their allergies.

Allergies affect up to 40 percent of American children (1), who miss about two million school days a year due to bothersome symptoms (2) such as itchy, watery eyes, sneezing, and a runny nose. Some allergy medicines are labeled to take every four to six hours, which may not cover the entire school day. Some may cause drowsiness or jitters, which may challenge the ability of young students to focus at school. CHILDREN'S CLARITIN Grape Chewables provide non- drowsy, non-jittery, all day relief while kids are at school so kids don't let allergy symptoms get in the way of doing their best work.

Nurse practitioner Regina Muccio, Pediatric Specialists of Foxborough and Wrentham, Mass., will now recommend CHILDREN'S CLARITIN Grape Chewables for the trusted relief of CLARITIN(R) allergy products that parents can rely on. "The chewable tablet is easy for kids to use, so all the medicine can go down easily every time," says Muccio.

CHILDREN'S CLARITIN Grape Chewables are safe for children ages two and up (3), and adds to the portfolio of CHILDREN'S CLARITIN formulations along with CHILDREN'S CLARITIN Fruit-flavored Syrup and Grape Syrup, introduced in 2005. CLARITIN(R) RediTabs(R) Tablets are approved for children ages 6 and up. Children who feel too old for syrup but not yet ready to use adult tablets now have an option that's just right.

CHILDREN'S CLARITIN Grape Chewables will be available at stores nationwide. For more information about CHILDREN'S CLARITIN visit http://www.claritin.com.

About CLARITIN

A pediatrician recommended brand, CHILDREN'S CLARITIN allergy products include CLARITIN Syrup, the first over-the-counter non-drowsy antihistamine safe for kids as young as two years of age. CLARITIN RediTabs Tablets is a once-daily tablet that melts instantly (4) in the mouth for children ages six and up. In 2003, the FDA approved CLARITIN Hives Relief(R)tablets as the first-ever indication for the OTC relief of itching due to hives, a common skin condition, for adults and children ages six and up.

About Schering-Plough

Schering-Plough Consumer Health Care is the U.S. over-the-counter (OTC) and consumer products business unit of Schering-Plough Corporation (NYSE: SGP), a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE:

The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to CLARITIN allergy products and the potential market for CLARITIN allergy products. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward- looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.

References:
(1) American Academy of Allergy, Asthma and Immunology. The Allergy Report. Vol. I. Rochester, NY: Academic Services Consortium, University of Rochester; 2000. 1.
(2) Meltzer EO. Quality of life in adults and children with allergic rhinitis. Mosby 2001. S49.
(3) When used as directed.
(4) Speed of dissolution does not imply speed of relief.

http://www.schering-plough.com
http://www.claritin.com

AERIUS Now Approved For Use In Intermittent And Persistent Allergic Rhinitis

Schering-Plough Corporation today announced the launch of two multinational clinical trials, and an important label change for AERIUS (desloratadine) in the European Union (EU).  The ACCEPT (AERIUS Control: Clinical and Epidemiological Profile of Tablets) trials will evaluate the efficacy, impact on quality of life, productivity, and pharmacoeconomics of AERIUS in patients with persistent allergic rhinitis (PER) (symptoms lasting four days or more per week and more than four weeks per year) or intermittent allergic rhinitis (IAR) (symptoms lasting less than four days per week or less than four weeks per year).  The trials will be conducted in collaboration with the Global Allergy and Asthma European Network (GA2LEN), a clinical research network of leading European research teams from 16 countries. 

            "The ACCEPT trials are the first multinational studies to involve many of our GA2LEN sites," said Paul Van Cauwenberge, Vice-Chancellor, Ghent University, Belgium and Coordinator of GA2LEN.  "This is a unique collaboration between researchers and industry.  We are pleased to be involved and look forward to expanding our knowledge of managing allergic rhinitis and building an important research partnership with Schering-Plough."             The launch of these trials coincides with the publication of the updated "Allergic Rhinitis and its Impact on Asthma" (ARIA) guidelines, developed by the World Health Organization. 

            Allergic rhinitis has traditionally been classified as seasonal or perennial based on the time of exposure and the nature of the allergen (outdoor or indoor).  According to the updated ARIA guidelines, allergic rhinitis also can be classified as intermittent (IAR) or persistent (PER), based on the duration of the condition rather than the exposure to a seasonal or perennial allergen.  The ACCEPT trials are among the first studies to evaluate an antihistamine based on the ARIA guidelines' classification of allergic rhinitis.

            The ACCEPT trials will involve more than 1,300 patients at nearly 100 sites in 13 countries, and are estimated to be completed in the spring of 2007.              "The ACCEPT trials are landmark studies which will help harmonize standards in the diagnosis and treatment of allergic rhinitis throughout Europe," said Torsten Zuberbier, MD Professor of Dermatology and Allergy, University of Berlin, and lead investigator on the ACCEPT studies.  "These studies will examine practical use of the new ARIA guidelines and evaluate the impact of treatment with desloratadine for patients with intermittent allergic rhinitis or persistent allergic rhinitis."

            The European Medicines Agency (EMEA) has adopted changes to the European Union (EU) label for AERIUS.  AERIUS is now approved for use in IAR and PER and the terms have been added to the Posology and method of administration section (4.2) and the Pharmacodynamic properties section (5.1) of the AERIUS Summary of Product Characteristics (SPC). 

            "Many patients are affected by both seasonal and perennial allergens.  The updated ARIA guidelines and the additional classifications of allergic rhinitis will help physicians more accurately assess and treat their patients' symptoms," said David Price, MD Professor, University of Aberdeen. 

About Allergic Rhinitis

As many as 94 million people across Europe are affected by allergic rhinitis (or hay fever) each year. 1   Symptoms may include sneezing, congestion, runny nose, and itchy or watery eyes.2 

            Symptoms of allergic rhinitis can have an impact on everyday activities at work, school and leisure time.  There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

            Survey data show that symptoms are most severe in the morning, and about two-thirds of respondents reported that morning suffering affects the rest of the day.3  Mornings can be an especially difficult time for all allergy sufferers in terms of allergic triggers because pollen concentrations are usually highest between 5 a.m. and 10 a.m.  In addition, if a pet is sleeping in the bed, exposure to their dander during the night may account for the increased prevalence and severity of morning allergy symptoms.  People with allergies also should shower before going to bed to rinse off any pollen or pet dander that may have collected in their hair or on their body during the day.

The survey also showed that even though allergies are frequently a self-diagnosed condition, patients rely on medical experts to help properly manage their symptoms.3

About AERIUS®

            According to the new classification of the labeling, AERIUS Tablets and AERIUS Syrup is now approved to treat symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis), in patients 12 years of age and older and patients 1 year of age and older, respectively.

AERIUS (desloratadine) is a nonsedating prescription antihistamine for the treatment of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria (CIU), or hives of unknown cause. AERIUS is available in two convenient forms.  In the European Union, AERIUS Tablets are available for adults and adolescents 12 years of age and older and AERIUS Syrup is available for children as young as 1 year of age.4

Research shows AERIUS provides powerful morning symptom relief.  In a study of 346 people with moderate-to-severe seasonal allergic rhinitis, patients receiving AERIUS experienced significant improvement in morning scores versus placebo for both nasal and non-nasal symptoms.5  AERIUS, which has a 27-hour half-life, offers demonstrated efficacy at the end of the dosing interval.

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache. In infants and toddlers aged 6 to 23 months who received AERIUS Syrup, the most frequent adverse events reported in excess of placebo were diarrhoea, fever and insomnia.  

About Schering-Plough Corporation

            Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE:  The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to AERIUS and the potential market for AERIUS.  Forward-looking statements relate to expectations or forecasts of future events.  Schering-Plough does not assume the obligation to update any forward-looking statement.  Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties.  For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.

# # # References: 
1. http://www.wrongdiagnosis.com/p/pollen_allergy/stats-country.htm.  Statistics for Northern, Western, Central, Eastern, Southwestern, Southern and Southeastern Europe combined.
2. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket Guide. 2001.
3. "Understanding the Dynamics Surrounding Allergy Suffering and Treatment" Forbes Consulting Group. 2005.
4. AERIUS (summary of product characteristics)  Schering Corporation.
5. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group.  Efficacy and tolerability of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest.  2001; 21:25-32.

http://www.schering-plough.com

April 16, 2007

Diet May Help Prevent Allergies And Asthma

A recent publication from the Global Allergy and Asthma European Network (GA2LEN) (1) provides new insights into the role that diet may play in the development of allergies, especially in children. The work suggests that the significant changes in European diets over the past 20-40 years may have contributed to the increased incidence of allergic diseases in both children and adults seen over this period. Members of the nutrition work package responsible for the report consider that its findings are just the beginning of GA2LEN's potential role in greater understanding of this complex area.

The prevalence of allergic diseases has increased dramatically over the past few decades, especially in children. One child in three is allergic today and one in two people in Europe are likely to be suffering from at least one allergy by 2015. It is generally agreed that a combination of heredity and environmental factors is responsible for the development of the allergy and asthma. However, the evolution of these diseases has been far too rapid for genetics to be the sole explanation. Among the wide range of environmental factors under discussion, changes in the European diet in the last 20-40 years are considered to be a possible explanation. Indeed, the way in which children are fed early in life may have a direct effect on the subsequent development of asthma and allergies, according to a recent publication from the Global Allergy and Asthma European Network (GA2LEN). (1)

In a paper entitled "Nutrition and allergic disease", published this year in Clinical and Experimental Allergy Reviews, 12 European experts working together in the GA2LEN nutrition work package present the evidence and define fertile topics for future research. (2) The work package team is led by Professor Philip C Calder, Institute of Human Nutrition, University of Southampton. (3)

Key findings: breastfeeding, early diet and probiotics

The three main areas producing key findings are breastfeeding, intake of certain nutrients, and probiotics. (4)

Exclusive breastfeeding, that is providing the infant with no other liquid or food other than breast milk, is believed to be effective in reducing subsequent development of allergies. It appears that exclusive breastfeeding for four months helps protect the child from cow's milk protein allergy until 18 months, reduces the likelihood of dermatitis (skin allergy) until three years, and reduces the risk of recurrent wheeze (or asthma) until six years' of age. However, the longer term effects of breast feeding on allergic outcomes are not known and require investigation.

The protective effect of four months of exclusive breastfeeding is important for all children but it is especially valuable for those at high risk of developing allergies. Children are at high risk of developing allergies if one or both parents are affected by allergic disease. If it is not possible for the high-risk child to be breastfed, hypoallergenic formula combined with avoidance of solid foods for 4-6 months offers an alternative source of protection. The studies show that hypoallergenic formula helps prevent cows' milk protein allergy developing before the age of five years and offers protection against atopic dermatitis (eczema or other skin allergy) until the age of four years.

A second major area of importance appears to be the components of the diet. For example, antioxidants in the diet, such as vitamin C, vitamin E and selenium coming mainly from fruit and vegetables, may have a protective effect. Furthermore, different fats found in milk, butter, vegetable oils and fish may have different effects on development of allergies and asthma. Although it is difficult to find clear-cut evidence, it appears that reducing sodium intake, increasing magnesium intake, eating apples and other fruit and vegetables, and avoiding margarine might help some asthmatics. However much of the research conducted to date has not been systematic in its approach and this makes the drawing of hard conclusions very difficult.

The role of probiotics and prebiotics in the diet is promising. Living organisms such as probiotics appear to protect against the development of allergies by producing changes in the bacteria in the gut that stimulate the immune system. A double blind, placebo-controlled study has recently shown that probiotics can help reduce the risk of atopic disease. This is an important area for future research.

Meeting the challenge

The review highlighted several areas in nutrition and diet that appear to be fruitful for future research in allergic disease, and therefore for future disease control. In particular, it has highlighted gaps in relation to specific effects of maternal and infant nutrition on allergy and asthma in later life. Patients, health professionals and policy makers alike would benefit from such research and from more large-scale studies on diet and allergy. Key focuses should be identification of dietary patterns or factors likely to be involved in altering risk of development of allergies and asthma, and developing the evidence base about whether supplementation with specific fats or probiotics could contribute both to the protection and treatment of allergic diseases. The studies required will need to be large and to be well planned, designed and executed. They are likely to require cross-country collaboration.

###

Notes:

1. GA2LEN - 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).

2. The 72-page peer-reviewed paper entitled "Nutrition and allergic disease" is published in Clinical and Experimental Allergy Reviews 6: 117-188, 2006 Blackwell Publishing Ltd.

3. The article represents the work of Workpackage 2.1 of GA2LEN. Correspondence should be addressed to the workpackage leader, P. C. Calder, BSc, PhD, DPhil, Professor of Nutritional Immunology, Institute of Nutrition, University of Southampton, UK.

4. The full list of indicators comprises: Sodium and potassium, magnesium, lipids including fatty acids in milk, butter, vegetable oils and fish, antioxidants, including fruit and vegetable intake, flavonoids and flavonoid-rich foods, Vitamin C, Vitamin E, b-Carotene, Vitamin A, selenium, zinc and copper, and probiotics and prebiotics.

Contacts:

P.C. Calder
Institute of Human Nutrition
School of Medicine
University of Southampton
Bassett Crescent East
Southampton SO16 7PX
UK.

GA2LEN Dissemination
Avenue Brugmann 151
B-1190 Brussels
Noelie Auvergne

For further information please visit:
GA2LEN And
University of Southampton

City Kids With Asthma Lose Out On Preventive Treatment

A new study by specialists at the Johns Hopkins Children's Center and elsewhere suggests that only one in five inner-city children with chronic asthma gets enough medicine to control dangerous flare-ups of the disease.

The findings, reported in December's Pediatrics, are disturbing, the researchers say, because preventive therapy failure leads to over-reliance on fast-acting 'rescue' drugs after an asthma attack strikes and to more complications and increased risk of death.

The scientists interviewed parents of 180 Baltimore city children 2 to 9 years of age diagnosed with persistent asthma and studied pharmacy records. Overall, only 20 percent of the 180 got the recommended amount of daily controller medication, which is six or more refills in a 12-month period. Sixty percent of children got too little therapy to fully prevent flare-ups and 20 percent either got no medication at all or relied solely on quick-relief rescue drugs, which stop an asthma attack from progressing.

Current guidelines call for any child asthmatic with wheezing, coughing and shortness of breath two or more times a week or night-time symptoms two or more times a month to use inhaled corticosteroids as controller drugs to curb inflammation and prevent acute attacks.

"It's clear that kids who need preventive drugs aren't getting them," says lead author Arlene Butz, Sc.D., R.N., asthma specialist at the Children's Center. Previous research indicates that inner-city children are at special risk because their living conditions include other asthma triggers, such as exposure to secondhand smoke and mouse and cockroach allergens.

The survey also showed that children cared for by asthma specialists in or out of the hospital were more likely to follow a proper drug regimen than those who were not in these groups.

Butz and colleagues said training primary care pediatricians to check pharmacy records will help them monitor their patients' adherence to the prescribed drug regimen.

Asthma is the country's leading pediatric chronic illness, affecting 6.2 million children under the age of 18.

###

Other Hopkins researchers in the study: Kim Mudd, M.S.N., of the Children's Center; and Michele Donithan, M.H.S., of the Johns Hopkins Bloomberg School of Public Health.

Other institutions participating in the study: University of Maryland. The study was funded by the National Institute of Nursing Research.

Contact: Katerina Pesheva
Johns Hopkins Medical Institutions

EU Prioritises Allergic Diseases In The Seventh Framework Programme For Research

GAВІLEN welcomes the vote of the European Parliament on the Seventh Framework Programme (FP7) on 30 November that acknowledges allergic diseases as major chronic diseases to be addressed in European research during the coming 7 years (2007 - 2013).

The European Parliament adopted the report of Prof. Jerzy Buzek that recognises “respiratory diseases including those induced by allergies” as health priorities to be addressed by translational research. This will allow respiratory allergic diseases (including asthma) to be covered by the research programme under the health theme.

In the first drafts, only food allergies (8% of all allergies) were covered. Allergic diseases will now be tackled under both the health and food themes of the research programme which should allow scientists to progress towards the overall understanding that is needed to help control this epidemic through effective prevention and treatment.

“Allergic diseases” in all their different aspects - from hay fever to fatal attacks of asthma or reactions to peanuts - are taking lives daily and creating huge financial costs. According to the World Health Organization, asthma kills someone in Europe every hour. One child in three is allergic today and by 2015, half of the European population may be suffering from one or more allergic condition.

The European Union’s next research programme known as the Seventh Framework Programme (FP7) begins on 1st January 2007 and will run for seven years until 2013 with a total budget of €54.6 billion.

GA²LEN - the Global Allergy and Asthma European Network is a “Network of Excellence” funded by the European Union 6th Research Framework Programme (FP6). 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). Close to 50 collaborating centres have joined the network since its launch in 2004.

http://www.ga2len.net

World Health Report 2003, “Shaping the Future”. World Health Organization

Vietnam Study Probes The Role Of Gut Worms In Allergies

Gut parasites could hold the key to increasingly common conditions such as eczema, asthma and hay fever, according to scientists at The University of Nottingham.

Gut parasites, such as hookworm, have evolved together with their human hosts for millions of years. Over time, these parasites have developed ways of surviving in the human gut by 'turning down' the immune response directed against them, prolonging their survival inside the host.

This reduction in immune response may also have the effect of reducing allergic tissue reactions that characterise asthma and other allergic conditions.

The latest study in this area of research is led by Dr Carsten Flohr, a clinical scientist from The University of Nottingham and Dr Luc Nguyen Tuyen, from the Khanh Hoa Provincial Health Service in central Vietnam. This work was supported through research grants from Asthma UK, the Bastow Award from the Special Trustees for Nottingham University Hospitals and a Fellowship from University College, University of Oxford.

Dr Flohr has examined the links between worms and allergic diseases in Vietnamese children and found that those with the highest level of hookworm infestation were the least likely to have an allergic response to house dust mites.

These findings support the hypothesis that gastrointestinal infection with either hookworms or other micro-organisms protects against allergy and add further weight to the so-called вЂ˜hygiene hypothesis’.

Dr Lyn Smurthwaite, Research Development Manager for Asthma UK said: “The вЂ˜hygiene hypothesis’ suggests that high rates of allergies and asthma in developed countries are a result of our immune systems becoming unbalanced due to improved sanitation and hygienic lifestyles that no longer expose us to the same array of bacteria, viruses or parasites. We look forward to future results in this area.”

The study involved 1,600 children aged six to 18, in four neighbouring rural communities in Khanh Hoa province, central Vietnam. Their lifestyles were studied, along with their sensitivity to common allergens and their level of infestation with hookworm and other parasites.

Following on from the study just reported online in the Journal of Allergy and Clinical Immunology, Dr Flohr and his colleagues in Vietnam have conducted an intervention study in the same population during which they regularly de-wormed schoolchildren to see whether this increased the prevalence of allergic diseases. This second study is now coming to a close and the results will be published early next year.

Dr Flohr said: “The results from such an intervention study will allow us to draw firmer conclusions as to whether gut worm infestation truly protects against allergic disease and sensitisation.”

Co-applicants on the Asthma UK research grant that is funding the work were Professors John Britton, David Pritchard, and Hywel Williams. The Nottingham team is collaborating with researchers from the Wellcome Trust Major Overseas Programme at the Oxford University Clinical Research Unit Hospital for Tropical Diseases in Ho Chi Minh City, where Dr Flohr has been based for his field work.

The University of Nottingham is leading the way in the investigation of links between hookworm infestation вЂ" or lack of it вЂ" and human illness. Two further currently ongoing trials are looking at the possibility that hookworm infection may alleviate symptoms of hay fever and Crohn’s Disease.

If these studies show positive results, future drugs that mimic the immunological effects of hookworm infection could provide promising therapeutic options for patients with allergic and other autoimmune diseases.

The University of Nottingham is Britain's University of the Year (The Times Higher Awards 2006). It undertakes world-changing research, provides innovative teaching and a student experience of the highest quality. Ranked by Newsweek in the world's Top 75 universities, its academics have won two Nobel Prizes since 2003. The University is an international institution with campuses in the United Kingdom, Malaysia and China.

Asthma UK is the charity dedicated to improving the health and well-being of the 5.2 million people in the UK whose lives are affected by asthma. It works together with people with asthma, health professionals and researchers to develop and share expertise to help people increase their understanding and reduce the effect of asthma on their lives.

The University of Nottingham

The Asthma And Allergy Foundation Of America And The HealthCentral Network To Develop Enhanced Internet Resources For Patients

The Asthma and Allergy Foundation of America (http://www.aafa.org) and The HealthCentral Network (http://www.TheHealthCentralNetwork.com), a Choice Media Division, announce that they will work together to create a new online resource for individuals with asthma and allergic disorders. The collaboration marries the deep health education expertise and resources of the Asthma and Allergy Foundation with The HealthCentral Network's multimedia capabilities and vast online community of patients and experts.

"This partnership with The HealthCentral Network offers us a valuable modern vehicle to disseminate our extensive library of multimedia educational materials," said Mike Tringale, M.S.M., the Foundation's Director of Marketing and Communications. Asthma and Allergy Foundation of America is the leading nonprofit patient organization focused on improving the quality of life for people with asthma and allergies and provides practical information, community based services and support through a national network of chapters and support groups. "One of our first joint projects will be to create a Web site portal to create opportunities for patients, providers and caregivers in the asthma and allergy community to connect," said Tringale. "Future projects will include the development of a blog allowing our supporters to interact on topics ranging from advocacy and policy issues, asthma and allergy program funding, patient rights, treatment guidelines and more."

The HealthCentral Network's new asthma Web site at http://www.MyAsthmaCentral.com and allergy Web site at http://www.MyAsthmaCentral.com are designed to leverage the wisdom and experience of asthma and allergy sufferers to help others coping with similar challenges. Building on a base of comprehensive medical information to inform and manage asthma, the new site seeks foremost to connect the asthma community through the voice of others who have been there. Through new tools such as customizable Web sites to keep extended families up-to-date during acute episodes, and regular blogs by those who can articulate the everyday realities of living with asthma, The HealthCentral Network seeks to provide in partnership with the Asthma and Allergy Foundation of America the ultimate community site to build awareness and understanding. More than 50 million individuals in the United States have allergies, and 20 million individuals have developed asthma, often triggered by or co-existing with other allergies.

"We are excited about promoting the Asthma and Allergy Foundation's award- winning educational programs, cutting edge research, and outstanding internet resources to our millions of Web site visitors on The HealthCentral Network," said Chris Schroeder, CEO and President of Choice Media. "Through this collaboration we hope to tap into the Foundation's network of local chapters and support groups to create an inspirational online community that captures the patient experience and addresses real world needs."

About The HealthCentral Network

The HealthCentral Network (http://www.aafa.org) is a division of Choice Media, Inc. and has over 30 general health and highly specific condition and wellness web properties, each committed to offering a voice in every day and personal language people can understand and connect with at critical points in their lives. Each site provides timely, interactive, in-depth, and trusted medical information, personalized tools and resources, and connections to vast communities of expertise for people seeking to engage in, manage and improve their health. The award-winning, multi-media experience combines medically-reviewed articles from doctors and researchers, as well as news, information, video and extensive engagement from every day people who have great experience and empathy in specific health areas. The Company also produces the Medical Breakthroughs television show, seen around the country.

Founded in the late 1990s, Choice Media, Inc. was recently acquired by a team of blue-chip investors including Sequoia Capital, Polaris Ventures, The Carlyle Group and Allen & Company. With a management team that combines decades of experience in interactive media and medical, science and news journalism, Choice Media, Inc. aims for the highest standards of quality, relevance and community for patients and their caregivers.

About the Asthma and Allergy Foundation of America

The Asthma and Allergy Foundation of America (AAFA), headquartered in Washington, DC, is the leading non-profit consumer and patient organization fighting asthma and allergic disease. The Foundation provides free information to the public, offers educational programs to consumers and health professionals, leads advocacy efforts to improve patient care and supports research to find cures. The Foundation's services include a toll-free hotline, counseling and educational materials, and a free caregiver magazine. For more than 50 years, the Asthma and Allergy Foundation has been a leader in fiscal responsibility and charity management and has a coveted four-star rating from Charity Navigator and is a member of the National Health Council. To learn more about The Asthma and Allergy Foundation of America, visit http://www.aafa.org.

The HealthCentral Network
http://www.TheHealthCentralNetwork.com

April 15, 2007

Studies Have Shown That Using Air Filters Can Help Reduce Allergies And Asthmatic Attacks

What Causes Asthma?

Asthma is an allergic reaction that can be brought on by a variety of triggers including certain foods, medicines, organisms, dander, mold and airborne pollution. An asthmatic attack can be very frightening for both the asthmatic and their friends and family. While an air purifier alone is not sufficient to remove all allergans and asthmatic triggers from a home, they can be an effective component in your arsenal.

Including Air Purifiers in your Arsenal to help Combat Asthma Attacks

A quality air purifier alone cannot trap all household allergans that may contribute to asthmatic attacks. The reason for this is that not all allergans are or remain airborne. For example, many people with allergies are allergic to dust mite droppings (feces) which fall out of the air and into carpeting, upholstery and linens rather quickly due to their relatively large size. In addition, allergy attacks can be brought on by the presence of certain organisms which are immune to air purification, such as cockroaches.

In a September, 2004 study co-funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Environmental Health Sciences (NIEHS), and published in the New England Journal of Medicine it was found that a HEPA air filter, when used in conjunction with dust mite proof mattress and pillow covers, cockroach extermination and a HEPA vacuum, dramatically reduced asthma symptoms.

Though no air cleaning system can remove all allergans from a home, studies have shown they can significantly reduce the levels of airborn allergans and irritants, in some cases, by up to 90%. The HEPA filter has long been used in laboratory experiments, and has been proven to reduce the level of particles in the air. Many air filtration systems rely solely on HEPA technology, or, include a HEPA filter as part of a multi-filtration system.

Multi Filter Air Cleaning Systems

There are purifiers available today that combine more than one type of air filtration technology. The HEPA filter is a widely known, effective and popular air filter. Newer technologies include ionization and UV filters, which, when combined with a HEPA, can trap or kill allergans and particles that are much smaller in size than was previously possible. There are some UV filters that can effectively treat airborne pollutants that are down to 0.001 microns in size. The HEPA air filter traps particles as tiny as 0.3 microns. Ionization technology for air filtration works by negatively producing negatively charged ions which attach themselves to contaminants. These contaminants then drop from the air, resulting in cleaner air to breathe. The HEPA operates by physically trapping particles that go through the filter. While the UV method works by killing or destroying germs.

While no air filtration system alone can remove all potential allergans from the air, they can definitely help reduce them. Subsequently helping to reduce the number of allergic or asthmatic attacks an individual may experience. Much of this depends on what the individual is allergic to, what filtration system they choose, and what other allergan-removal methods they employ in their home environment. A quality air purifier can be a valuable tool in fighting allergies and the effects of asthma.

By Michelle O'Connor
Air Purifying Your Home

Replacing Old Mattress, Adding Ventilation Reduces Mites

Reducing the level of dust mites in the bedroom can be achieved by replacing old mattresses and increasing a room's ventilation, according to a new study.

The study, which was based on data collected from the European Community Respiratory Health Survey II, can be found in articles in press area of the Journal of Allergy and Clinical Immunology (JACI) Web site, http://www.jacionline.org. The JACI is the peer-reviewed journal of the American Academy of Allergy, Asthma and Immunology (AAAAI).

In "Distribution and determinants of house dust mite allergen in Europe: The European Community Respiratory Health Survey II," Jan-Paul Zock, PhD, Municipal Institute of Medical Research, Barcelona, Spain, and colleagues looked to determine the distribution of two common house dust mites and what conditions would affect the level of those allergens in each home.

More than 3,500 samples of dust were taken from mattresses found in homes in 22 different study centers throughout Europe and analyzed for the different dust mite allergens. A bed in each home was stripped of linens and an 80cm x 125cm template was placed on the area of the bed where the participant usually slept, and that area was vacuumed to collect the dust samples.

Researchers found that Der 1 and Der 2 dust mite allergens were detectable in 68% and 53% of all samples, respectively, and that large differences in allergen levels occurred between study centers. Important risk factors for high allergen levels included an older mattress, a lower floor level of the bedroom, limited ventilation of bedroom and for one of the dust mites sampled, the level of dampness in the bedroom. Zock and colleagues concluded mite allergen exposure may be reduced by replacing the mattress regularly and increasing ventilation in the bedroom, particularly in winter.

Another study that resulted from the survey showed cat allergens may be present in homes that are cat-free.

Joachim Henrich, PhD, National Research Center for Environmental Health, Institute of Epidemiology, Neuherberg, Germany, and colleagues' study, "Cat allergen level: Its determinants and relationship to specific IgE to cat across European Centers," measured the quantity of cat allergen in mattress dust, and then analyzed the relationship between cat ownership and the level of cat allergen found in the participants' homes. The study can be found in the articles in press area of the JACI Web site, http://www.jacionline.org.

Like the Zock study, dust was vacuumed from the mattresses, with 2,800 mattresses from homes 22 different communities sampled. Current cat owners' homes had substantially higher amounts of allergens than past cat owners and those who had never owned a cat.

While never having a cat in the home led to a lower concentration of cat allergen, it didn't protect against high cat allergen exposure in communities where cat ownership is common. The researchers concluded that people who do not own cats may still be exposed to high levels of cat allergen in the home because cat ownership is common in their community and they bring the allergen home on their clothes. Indoor smoking was also found to lead to higher level of cat allergens, possibly because cat allergens can bind to the smoking-related particulate matter, and consequently, allergen concentrations might be increased in settled dust.

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. Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic 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.

EDI 555 East Wells St., Ste 1100
Milwaukee, WI 53202
United States

http://www.aaaai.org
http://www.aaaai.org/public/default.stm

Prevalence Of Childhood Allergies Has Increased Over Past Decade

The prevalence of childhood allergies, such as hayfever, have increased over the past decade in many countries of the world, especially among younger age groups, reveals an Article in this week's issue of The Lancet.

In 1991 researchers carried out the International Study of Asthma and Allergies in Childhood (ISAAC) to assess the worldwide prevalence of asthma, hayfever, and eczema*. Between 2002 and 2003, Innes Asher (University of Auckland, New Zealand) and colleagues repeated ISAAC to examine any changes in prevalence. The investigators surveyed the parents of over 193 400 children aged 6-7 years from 37 countries on the presence of symptoms of asthma and allergies, such as wheezing, in their child. They also asked around 304 680 children, aged 13-14 years from 56 countries, the same questions. Developing countries such as South Africa, Brazil, and Iran and developed countries such as Canada, New Zealand, Sweden, and the UK contributed to the study.

The investigators found that increases in prevalence were more common than decreases and occurred more commonly in the younger age-group. The increases were greatest for eczema in the younger age-group, and for hayfever in both age-groups. However, in the older age group where prevalence of asthma had been previously been high, symptoms of the condition more commonly decreased. The only regions where increases in prevalence of all three disorders occurred more often in both age-groups than decreases were Asia-Pacific and India.

In the UK, where around 1700 children took part in the study, asthma prevalence went up from 18.4% to 20.9%, hayfever from 9.8% to 10.1%, and eczema from 13% to 16% between 1991 and 2003.

Professor Asher concludes: "The data have direct relevance for health-service delivery in the countries included in the study as well as providing a basis for understanding these disorders. In almost all centres, there was a change in prevalence of one or more disorders over time. Although changes in mean annual prevalence to the order of 0.5% might sound small, such changes could have substantial pubic-health implications, especially since the increases took place most commonly in heavily populated countries."

###

Contact: Professor Innes Asher, Department of Paediatrics, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland, New Zealand. mi.asher@auckland.ac.nz

Notes to editors

*Eczema - describes a group of skin conditions where the skin becomes inflamed, red, and itchy.

Contact: Joe Santangelo
Lancet

Childhood Allergies Have Increased Globally Since 1991

Childhood allergies have become more widespread around the globe since 1991, according to a large study. The most common allergies are hayfever, asthma and eczema. In the UK, a study of 1,700 children found asthma prevalence went up from 18.4% in 1991 to 20.9% in 2003 - for the same period hayfever prevalence went up from 9.8% to 10.1% and eczema rose from 13% to 16%.

Between 2002 and 2003, Professor Innes Asher, Department of Paediatrics, Faculty of Medical and Health Sciences, University of Auckland, New Zealand, and team, repeated a 1991 study called The International Study of Asthma and Allergies in Childhood (ISAAC) to asses global prevalence of asthma, hayfever and eczema.

193,400 children, aged 6-7, from 37 different countries were monitored for symptoms of asthma and other allergies, such as wheezing. The researchers used feedback from the children's parents for this study. Another 304,680 children, aged 13-14, from 56 different countries, were surveyed directly with the same questions. The study included children from developing countries, such as Brazil, South Africa and Iran, as well as developed countries, such as the UK, Swede, Canada and New Zealand.

The researchers found that:

-- Rises in prevalence were more common than falls - especially among younger children

-- Eczema has become more widespread worldwide among younger children

-- Hayfever has become more prevalent globally among all age-groups

--Asthma prevalence among older kids, which had previously been high, more commonly decreased

--Only in India and the Asia-Pacific region has the prevalence of all three disorders - asthma, hayfever and eczema - increased in all age-groups.

Prof. Innes Asher concludes that the data have direct relevance for health-service delivery in the countries included in the study, as well as providing a basis for understanding these disorders. Almost everywhere there has been a change in prevalence of one or more disorders over time. Seemingly small increases of 0.5% may seem insignificant. However, they have substantial public-health implications, especially as they often appear to take place in densely populated areas.

Worldwide time trends in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One and Three repeat multicountry cross-sectional surveys
Prof M Innes Asher MBChB, Stephen Montefort MD, Bengt Bjцrkstйn MD, Christopher KW Lai DM, David P Strachan MD, Stephan K Weiland MD and Hywel Williams PhD, the ISAAC Phase Three Study Group
The Lancet 2006; 368:733-743
DOI:10.1016/S0140-6736(06)69283-0
Click Here To View Abstract (You will need to register - Free)

Written by: Christian Nordqvist
Editor: Medical News Today

New Children's Claritin(R) Grape Chewables Provide Non-Jittery, Non-Drowsy, All Day Relief For Kids' Allergy Symptoms

Helping young kids relieve their allergies during the busy back-to-school season just got easier. Schering-Plough Corporation (NYSE: SGP) today announced the introduction of CHILDREN'S CLARITIN(R) Grape Chewables, a pleasant-tasting, convenient and easy-to-take form of CHILDREN'S CLARITIN that relieves kids' worst allergy symptoms without causing jitteriness or drowsiness so they can focus on their school work -- not their allergies.

Allergies affect up to 40 percent of American children (1), who miss about two million school days a year due to bothersome symptoms (2) such as itchy, watery eyes, sneezing, and a runny nose. Some allergy medicines are labeled to take every four to six hours, which may not cover the entire school day. Some may cause drowsiness or jitters, which may challenge the ability of young students to focus at school. CHILDREN'S CLARITIN Grape Chewables provide non- drowsy, non-jittery, all day relief while kids are at school so kids don't let allergy symptoms get in the way of doing their best work.

Nurse practitioner Regina Muccio, Pediatric Specialists of Foxborough and Wrentham, Mass., will now recommend CHILDREN'S CLARITIN Grape Chewables for the trusted relief of CLARITIN(R) allergy products that parents can rely on. "The chewable tablet is easy for kids to use, so all the medicine can go down easily every time," says Muccio.

CHILDREN'S CLARITIN Grape Chewables are safe for children ages two and up (3), and adds to the portfolio of CHILDREN'S CLARITIN formulations along with CHILDREN'S CLARITIN Fruit-flavored Syrup and Grape Syrup, introduced in 2005. CLARITIN(R) RediTabs(R) Tablets are approved for children ages 6 and up. Children who feel too old for syrup but not yet ready to use adult tablets now have an option that's just right.

CHILDREN'S CLARITIN Grape Chewables will be available at stores nationwide. For more information about CHILDREN'S CLARITIN visit http://www.claritin.com.

About CLARITIN

A pediatrician recommended brand, CHILDREN'S CLARITIN allergy products include CLARITIN Syrup, the first over-the-counter non-drowsy antihistamine safe for kids as young as two years of age. CLARITIN RediTabs Tablets is a once-daily tablet that melts instantly (4) in the mouth for children ages six and up. In 2003, the FDA approved CLARITIN Hives Relief(R)tablets as the first-ever indication for the OTC relief of itching due to hives, a common skin condition, for adults and children ages six and up.

About Schering-Plough

Schering-Plough Consumer Health Care is the U.S. over-the-counter (OTC) and consumer products business unit of Schering-Plough Corporation (NYSE: SGP), a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE:

The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to CLARITIN allergy products and the potential market for CLARITIN allergy products. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward- looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.

References:
(1) American Academy of Allergy, Asthma and Immunology. The Allergy Report. Vol. I. Rochester, NY: Academic Services Consortium, University of Rochester; 2000. 1.
(2) Meltzer EO. Quality of life in adults and children with allergic rhinitis. Mosby 2001. S49.
(3) When used as directed.
(4) Speed of dissolution does not imply speed of relief.

http://www.schering-plough.com
http://www.claritin.com

AERIUS Now Approved For Use In Intermittent And Persistent Allergic Rhinitis

Schering-Plough Corporation today announced the launch of two multinational clinical trials, and an important label change for AERIUS (desloratadine) in the European Union (EU).  The ACCEPT (AERIUS Control: Clinical and Epidemiological Profile of Tablets) trials will evaluate the efficacy, impact on quality of life, productivity, and pharmacoeconomics of AERIUS in patients with persistent allergic rhinitis (PER) (symptoms lasting four days or more per week and more than four weeks per year) or intermittent allergic rhinitis (IAR) (symptoms lasting less than four days per week or less than four weeks per year).  The trials will be conducted in collaboration with the Global Allergy and Asthma European Network (GA2LEN), a clinical research network of leading European research teams from 16 countries. 

            "The ACCEPT trials are the first multinational studies to involve many of our GA2LEN sites," said Paul Van Cauwenberge, Vice-Chancellor, Ghent University, Belgium and Coordinator of GA2LEN.  "This is a unique collaboration between researchers and industry.  We are pleased to be involved and look forward to expanding our knowledge of managing allergic rhinitis and building an important research partnership with Schering-Plough."             The launch of these trials coincides with the publication of the updated "Allergic Rhinitis and its Impact on Asthma" (ARIA) guidelines, developed by the World Health Organization. 

            Allergic rhinitis has traditionally been classified as seasonal or perennial based on the time of exposure and the nature of the allergen (outdoor or indoor).  According to the updated ARIA guidelines, allergic rhinitis also can be classified as intermittent (IAR) or persistent (PER), based on the duration of the condition rather than the exposure to a seasonal or perennial allergen.  The ACCEPT trials are among the first studies to evaluate an antihistamine based on the ARIA guidelines' classification of allergic rhinitis.

            The ACCEPT trials will involve more than 1,300 patients at nearly 100 sites in 13 countries, and are estimated to be completed in the spring of 2007.              "The ACCEPT trials are landmark studies which will help harmonize standards in the diagnosis and treatment of allergic rhinitis throughout Europe," said Torsten Zuberbier, MD Professor of Dermatology and Allergy, University of Berlin, and lead investigator on the ACCEPT studies.  "These studies will examine practical use of the new ARIA guidelines and evaluate the impact of treatment with desloratadine for patients with intermittent allergic rhinitis or persistent allergic rhinitis."

            The European Medicines Agency (EMEA) has adopted changes to the European Union (EU) label for AERIUS.  AERIUS is now approved for use in IAR and PER and the terms have been added to the Posology and method of administration section (4.2) and the Pharmacodynamic properties section (5.1) of the AERIUS Summary of Product Characteristics (SPC). 

            "Many patients are affected by both seasonal and perennial allergens.  The updated ARIA guidelines and the additional classifications of allergic rhinitis will help physicians more accurately assess and treat their patients' symptoms," said David Price, MD Professor, University of Aberdeen. 

About Allergic Rhinitis

As many as 94 million people across Europe are affected by allergic rhinitis (or hay fever) each year. 1   Symptoms may include sneezing, congestion, runny nose, and itchy or watery eyes.2 

            Symptoms of allergic rhinitis can have an impact on everyday activities at work, school and leisure time.  There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

            Survey data show that symptoms are most severe in the morning, and about two-thirds of respondents reported that morning suffering affects the rest of the day.3  Mornings can be an especially difficult time for all allergy sufferers in terms of allergic triggers because pollen concentrations are usually highest between 5 a.m. and 10 a.m.  In addition, if a pet is sleeping in the bed, exposure to their dander during the night may account for the increased prevalence and severity of morning allergy symptoms.  People with allergies also should shower before going to bed to rinse off any pollen or pet dander that may have collected in their hair or on their body during the day.

The survey also showed that even though allergies are frequently a self-diagnosed condition, patients rely on medical experts to help properly manage their symptoms.3

About AERIUS®

            According to the new classification of the labeling, AERIUS Tablets and AERIUS Syrup is now approved to treat symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis), in patients 12 years of age and older and patients 1 year of age and older, respectively.

AERIUS (desloratadine) is a nonsedating prescription antihistamine for the treatment of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria (CIU), or hives of unknown cause. AERIUS is available in two convenient forms.  In the European Union, AERIUS Tablets are available for adults and adolescents 12 years of age and older and AERIUS Syrup is available for children as young as 1 year of age.4

Research shows AERIUS provides powerful morning symptom relief.  In a study of 346 people with moderate-to-severe seasonal allergic rhinitis, patients receiving AERIUS experienced significant improvement in morning scores versus placebo for both nasal and non-nasal symptoms.5  AERIUS, which has a 27-hour half-life, offers demonstrated efficacy at the end of the dosing interval.

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache. In infants and toddlers aged 6 to 23 months who received AERIUS Syrup, the most frequent adverse events reported in excess of placebo were diarrhoea, fever and insomnia.  

About Schering-Plough Corporation

            Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE:  The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to AERIUS and the potential market for AERIUS.  Forward-looking statements relate to expectations or forecasts of future events.  Schering-Plough does not assume the obligation to update any forward-looking statement.  Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties.  For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.

# # # References: 
1. http://www.wrongdiagnosis.com/p/pollen_allergy/stats-country.htm.  Statistics for Northern, Western, Central, Eastern, Southwestern, Southern and Southeastern Europe combined.
2. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket Guide. 2001.
3. "Understanding the Dynamics Surrounding Allergy Suffering and Treatment" Forbes Consulting Group. 2005.
4. AERIUS (summary of product characteristics)  Schering Corporation.
5. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group.  Efficacy and tolerability of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest.  2001; 21:25-32.

http://www.schering-plough.com

Studies Help Rank 50 Factors Influencing Child Allergy

A workshop starting today will hear that a European Union funded research project has standardised 20 birth cohorts so that their findings can be used to appraise the contribution of different known factors influencing allergy in childhood. Dr Susanne Lau, who leads the work programme on birth cohorts in the Global Allergy and Asthma European Network (GAІLEN), will describe the achievements of her study.

A unique Europe-wide database tracking 50 factors that may have an affect on allergy in children will be presented on Tuesday, 12 September 2006. The announcement will be made at a workshop on birth cohort and intervention studies in Berlin (1).

The achievement is the initiative of GAІLEN, an EU-funded research "network of excellence" on allergies and asthma (2). Dr. Susanne Lau, who is responsible for the Birth Cohort project involving 30 researchers and their teams in centres throughout Europe, will present her work. She says: "Collaboration with so many European teams is a fantastic asset for the quality of our research projects and for the quality of their results. We'll be able to paint a much more accurate picture of key factors influencing allergies even if we can't make comparisons on prevalence and cause-effect relationships."

The significance of this scientific work by one of Europe's largest network on allergies and asthma has been acknowledged internationally. A research team in Australia have asked permission to use the European model for a database on allergies for the Asian-Pacific region.

Two scientific papers about 18 of the 20 harmonised birth cohorts on children and asthma, allergic rhinitis (hay fever) or eczema have recently appeared in Allergy journal. (3) The 30,000 children involved in these study groups, or birth cohorts, are spread through different countries in Europe, though most are living in urban areas. Many of the children continue to be involved in ongoing studies.

Not all 50 influencing factors are followed in all the harmonised birth cohorts. However, the huge new database means that larger sub-samples are available to medical scientists for analysis. This opens up new possibilities for greater accuracy in assessing not only the risks associated with the development of allergy but also the factors that may play a role in prevention. Some of influencing variables in the overall database are pet exposure, tobacco smoke exposure, number of siblings, atopic family history, housing conditions, delivery, medications, infections, and the results of allergen testing, such as IgE both in the child's blood and in the cord blood before the child was born.

One sub-sample provides the results of skin prick test for IgE of 1,000 children during the first six years of life. Each child was tested for grass, tree pollen, mite, cat, dog, cow's milk and hen's egg allergens. These results can be correlated with assessments of the symptoms associated with asthma (wheezing) and allergic rhinitis in the same sub-group. Information on symptoms is more generally available because most studies have used a standard questionnaire developed by a major international study known as ISAAC. (4) Both "parental perception of symptoms" and "doctor's diagnosis of asthma" are usually available.

One of the main objectives of GAІLEN is to spread excellence in the domain of research on allergy and asthma. Rising prevalence of allergic disease is a growing public health problem. (5) "This large, standardised data base, plus the harmonization of follow up procedures and study design, can increase the quality of the studies and therefore contribute to worldwide understanding of the factors influencing allergy diseases," Dr Lau says.

Joint workshop

The aim of the workshop (12-13 September) is to provide support to those planning and conducting both longitudinal birth cohort and intervention studies to investigate or prevent allergies and asthma. It is organised jointly with EuroPREVALL (6), an EU-funded research project on food allergies, based in Berlin where the workshop will take place.

EuroPREVALL is currently developing an intervention study of food allergies in during the first year of life. Recruitment began in October 2005 and eight centres are already active (Germany, Poland, Greece, the UK, the Netherlands, Iceland, Lithuania and Spain). Of the 4,000 infants being followed to date, 66 (1.5 per cent) have developed symptoms that may indicate a food-related allergy. Clinicians are following these children more closely, and for each child with symptoms, two age-matched controls will be given the allergen tests so that results can be compared.

About the GAІLEN

GAІLEN, "Global Allergy and Asthma European Network", is a Network of Excellence funded by the European Union under the 6th Framework Programme. GAІLEN leading research teams address all aspects of allergic diseases, including asthma, with a multidisciplinary approach. The objectives are to enhance the quality and integration in European research and to accelerate the application of results to clinical practice, patients' needs and policy development.

GAІLEN

Avenue Louise 327
BP6
http://www.ga2len.net

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

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

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