Eczema And Hay Fever May Be Falling After Rising In Recent Decades

After having risen year on year in recent decades, the rates of eczema and hay fever seem to have stabilised, and may even be falling, suggests research published ahead of print in Thorax.

But the rates of systemic allergic reactions, such as anaphylaxis and those related to food have soared, the data suggest.

The research team carried out a time trends analysis on the rates of illness and death for allergic disorders, excluding asthma.

They used national representative data and information from national surveys, consultations with primary care health practitioners, prescriptions, hospital admissions, and deaths.

Diagnoses of allergic rhinitis and eczema in children have trebled over the past three decades, but the prevalence of symptoms seems to have fallen recently.

Hospital admissions for eczema have also stabilised since 1995, while those for allergic rhinitis have fallen to about 40% of their 1990 levels.

Similarly, consultations with a family doctor for hay fever rose by 260%, and for eczema by 150%, between 1971 and 1991. But once again, rates have stabilised in the past decade, the figures indicate.

However, hospital admissions for anaphylaxis (serious allergic reaction in several areas of the body) have risen by 700%, those for food allergy by 500%, and those for the skin allergy urticaria by 100%.

Rates of angio-oedema, in which an absence of a specific protein promotes tissue swelling, leading to difficulties breathing, also rose by 40%.

Prescriptions for all types of allergy have also increased since 1991, the data show.

The findings suggest that while eczema and hay fever may have peaked, systemic allergies may be on the increase, say the authors.

They speculate that some of the trends could be explained by changes in medical practice and care, but they could also be attributable to changes in the sources of allergic disease.

###

Contact: Emma Dickinson
BMJ Specialty Journals

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

Are The Dangers Of Childhood Food Allergy Exaggerated?

Two child health experts go head to head in this week's BMJ over whether the dangers of childhood food allergy are exaggerated.

Professor Allan Colver from the University of Newcastle upon Tyne believes that the dangers are overstated, and that the increasing prescription of adrenaline injector kits fuels anxiety rather than saving lives.

Food allergy is often thought to be more dangerous and frightening than pneumonia, asthma, or diabetes, he writes. In reality, the risk of death is very small. Eight children under 16 years died from food allergy between 1990 and 2000 in the UK. That is one death per 16 million children each year. Yet childhood food allergy is being diagnosed more often and the number of prescribed adrenaline kits has greatly increased.

A diagnosis of food allergy creates much anxiety for all who care for the child, so it is important to get the diagnosis right, take sensible measures to reduce risk, and reassess regularly to check whether the child has grown out of their allergy, he says.

It is unclear what proportion of children with food allergy should be prescribed an adrenaline kit. The main argument in its favour is that reactions are best treated within a few minutes rather than waiting for medical assistance. But Colver suggests that they cause unnecessary anxiety, may not prevent death, and should be prescribed only when a diagnosis of food allergy has been confidently established.

The dangers of food allergies are not exaggerated, argues Professor Jonathan Hourihane from University College Cork, Ireland. Food allergy is common - 2% of adults and up to 6% of preschool children are affected and, although deaths are rare, other reactions are almost inevitable over time.

No tests are available to predict who will or will not have a severe allergic reaction, so management consists of empowering patients and providing rescue drugs. Delay in use of these drugs is associated with a worse outcome in severe reactions.

Proper management in allergy clinics means that most patients never have to use these drugs, but it is wrong to say that they are not needed, he says. Nobody is advocating "more general use" of adrenaline. What is advocated is increased availability of adrenaline kits for people who might need to use them. They should not be withheld because of the medical uncertainty surrounding allergy.

Food allergy is here to stay, he writes. The disease is a killer (though rarely); it can erode or inhibit normal formative experiences in childhood, and it impairs a child's quality of life. Let's get allergy services out of the academic centres and into the community, which is where food allergy is really "dangerous," he concludes.

Click here to view full paper: http://press.psprings.co.uk/bmj/september/ac494.pdf

Click here to view full contents for this week's print journal:
http://press.psprings.co.uk/bmj/september/contents.pdf

BMA House, Tavistock Sq
London WC1H 9JP
United Kingdom
http://www.bmj.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

Nippon Paper Begins Test Farming Rice That Alleviates Hay Fever

Nippon Paper Group has started test farming a rice which could alleviate hay-fever symptoms. The rice was specially developed using the MAT vector system, a biotechnology for genetically extracting certain genomes, in this case an epitope in the rice. The epitope will act as a vaccine for hay-fever, so people who eat it will experience fewer hay-fever symptoms when the season arrives.

Nippon Paper will set up a large greenhouse of 500 square meters on the island of Komatsu. With proper light and temperature control, the greenhouse will yield 700 kilograms of rice annually.

The project was commissioned by the Ministry of Agriculture, Forestry, and Fisheries.

By Chris Lui, JCN Staff Writer

Copyright © 2006 JCN. All rights reserved. A division of Japan Corporate News Network KK.

JCN

The Allergens And Irritants Behind Itchy Skin

What could be the reason for skin that's inflamed, itchy, dotted with bumps or blisters?

According to the September issue of Mayo Clinic Women's HealthSource, it could be contact dermatitis, caused by exposure to an allergen or simply something that irritates the skin.

Irritants can include soaps and detergents. Even plain water can irritate skin with frequent hand washing.

If the culprit is an allergy, the skin doesn't usually react to the first exposure. It can take many exposures for the skin to become sensitive. So, your favorite earrings could be causing the problem. The most common allergens are nickel, a metal commonly used in jewelry, buttons, hooks and zippers; and gold, a precious metal used in jewelry.

Both allergic and irritant contact dermatitis may appear on your hands. But allergic contact dermatitis -- along with other skin conditions such as psoriasis -- may be suspected if you develop a rash on your scalp, neck, earlobes, eyelids, lips or underarms.

Your primary doctor or a dermatologist often can base a diagnosis on your skin's appearance and your recent history of contact with allergens and irritants. If no allergen or irritant is apparent, and your symptoms become chronic, patch testing may be advised. In this procedure, small amounts of different allergens are applied, usually to your back to see how your skin reacts.

Identifying and avoiding an allergen or irritant is the primary treatment. Topical creams containing hydrocortisone or a wet dressing also may be recommended to relieve redness, itching and discomfort. Oral medications may be needed for severe reactions.

Don't expect overnight results. Even with strict allergen or irritant avoidance, contact dermatitis may take weeks or months to clear up.

Mayo Clinic

200 First St. SW
Rochester, MN 55902
United States
http://www.mayo.edu/news/

Colorado Company To Sell Medical Food Products Based On Wake Forest Discovery

A Colorado-based company is launching a line of "medical- food" products for the dietary management of asthma, eczema and other allergic conditions based on discoveries by Floyd H. "Ski" Chilton, Ph.D., of Wake Forest University Health Sciences (WFUHS).

Chilton's discoveries originally led to the founding of a company called Pilot Therapeutics. Now Pilot Therapeutics and WFUHS have licensed rights to the technology to Efficas Inc. of Boulder, Colo., to allow Efficas to produce and market the therapeutic products, said Michael A. Batalia, Ph.D., director of the Office of Technology Asset Management at Wake Forest.

The EfficasTM Care products are aimed at three health conditions: asthma, eczema and allergy. The Efficas Care line is now available for online purchase.

Research by Chilton, professor of physiology and pharmacology at Wake Forest University School of Medicine, focuses on the role that diet or medical foods play in human disease. As the founder of Pilot Therapeutics, he developed an over-the-counter medical food designed to reduce the production of leukotrienes, substances known to play a significant role in asthma and allergy attacks.

"Through our research and clinical trials, we have learned that allergic individuals have a unique dietary need for two fatty acids, GLA (gamma-linolenic acid) and EPA (eicosapentaenoic acid)," Chilton said. "Our studies also show that increased consumption of these nutrients can inhibit leukotriene production in patients."

The new products contain a patented formula of marine oil and botanical oil (borage seed oil) that contains the optimal amount and ratio of GLA and EPA.

"The new licensing arrangement between Efficas, WFUHS and Pilot Therapeutics will allow both companies to advance new technology," Batalia said. "Efficas is a well-funded health science and technology development company with the resources to market these new products, and Pilot Therapeutics now can move on to other product developments."

Besides founding Pilot Therapeutics, Chilton is also director of a WFUHS research program studying dietary supplements, one of five in the country. The program is supported by a $7.5 million grant from the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements.

The Wake Forest program is a partnership with Brigham and Women's Hospital in Boston and is known as the Wake Forest and Brigham and Women's Program for Botanical Lipids. Botanicals are plant-based dietary ingredients. One of the four main research projects focuses on how borage, marine and echium oils reduce inflammatory messengers that cause diseases such as asthma and arthritis. (Echium oil is a natural vegetable oil rich in short-chain omega-3 polyunsaturated fatty acids that are converted by humans to the fat equivalent of fish oil.)

Efficas, Inc. is a Boulder-based health science and technology development company "committed to developing science-based products for the nutritional management of the immune system both for humans and pets," according to a company news release.

Efficas has received funding from Life Science Partners BioVentures, Burrill and Company, Great Spirit Ventures, Unilever Technology Ventures, JP Morgan Bay Area Equity Fund and Prolog Ventures

"Immune-related conditions affect millions of people and we believe leukotriene-inhibiting technology holds great promise for improved quality of life for these individuals," said Mark Braman, chief executive officer of Efficas.

"Marketing first via the Web allows us to efficiently reach out to the millions of proactive consumers who are seeking information and alternative treatments online," Braman said. "We will follow with specialty and natural retail distribution, then mass retail distribution to make our products more easily accessible to the broader population."

###

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine and its other related enterprises including the Piedmont Triad Research Park. The Medical School is ranked 4th in the Southeastern United States in revenues from its licensed intellectual property.

Contact: Robert Conn
Wake Forest University Baptist Medical Center

1st International Study Group For New 'Movement' Discipline

Movement ecology is on the move, with the world's first international research group on this topic having begun its work this fall at the Hebrew University of Jerusalem's Institute for Advanced Studies

Movement ecology is a developing academic pursuit, combining expertise in a variety of fields, including biology, ecology, botany, environmental science, physics, mathematics, virology and others.

It has been largely developed by a Hebrew University of Jerusalem researcher, Prof. Ran Nathan, who heads the Movement Ecology Laboratory in the Department of Evolution, Systematics and Ecology at the university's Alexander Silberman Institute of Life Sciences.. It involves the study of how plant and animal matter travels from one place to another, sometimes for great distances and in highly surprising ways.

The research group now at work at the Hebrew University's Institute for Advanced Studies was convened at the initiative and under the leadership of Prof. Nathan and includes participants from the University of California at Berkeley, the University of California at Davis, Princeton University, Stony Brook University and Rutgers University, all from the U.S.; the Spanish Research Council; and from the Hebrew University, Ben-Gurion University of the Negev and the Technion - Israel Institute of Technology.

Prof. Nathan emphasizes that organism movement research is central to the understanding of how ecological systems work and has important implications for human life. A comprehensive understanding of movement as a process will help to conserve biodiversity, adapt to changes produced by global warming, and cope with environmental threats such as infectious diseases, invasive alien species, agricultural pests and the spread of allergens.

The field of movement ecology and Prof. Nathan were given a large boost of recognition in a recent special issue of Science magazine on migration and dispersal. The issue included an article by Prof. Ran Nathan on his specialty of long-distance dispersal of plants.

In addition, the same issue contained a news article which largely focused on the work of Nathan and his students, as well as others in the U.S., Britain and Australia, focusing on dispersal of both plants and animals.

The article noted that researchers have sought, for centuries, "to understand when, why and how various species crawl, swim, fly, float or hoof it to new locales. That work has led to maps of migration routes and details about dispersals."

"But," the article quoted Prof. Nathan as saying, "few biologists have tried to fit those data into a big picture of movement in general." Now, said the article, through the new discipline called movement ecology, Nathan and others "are beginning to derive testable hypotheses about the mobile behaviors of animals, microbes and even the seeds of plants. Their goal is to join empirical work to theories and to build models that fill in gaps in our understanding of movement -- be it over millimeters or continents or by groups of individuals - in the natural world."

Last year, Nathan was chosen as the winner of the Hebrew University President's Prize for the Outstanding Young Researcher for his pioneering work on seed dispersal. In May this year he was awarded the prestigious Wilhelm Bessel Research Award from the Humboldt Foundation of Germany.

###

Contact: Jerry Barach
The Hebrew University of Jerusalem

China Biopharmaceuticals Holdings Completes All Clinical Trials Of Desloratadine For Hay Fever

China Biopharmaceuticals Holdings, Inc. (OTC Bulletin Board: CHBP), a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever. The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.

Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.

CHBP President and Chief Operating Officer Lufan An said, "We are pleased to have completed all the required clinical trials for Desloratadine for the SFDA's review. We hope to have the SFDA's approval to manufacture and market this drug by the end of 2007. If we are granted production approval, CHBP will be one of only four pharmaceutical companies producing Desloratadine tablets in China through 2010. This is the latest accomplishment of our R&D team which has submitted 15 drug applications to the SFDA during this calendar year."

In a separate release, CHBP also announced today that it is one of only three companies that received authorization from the SFDA to initiate clinical trials to evaluate the safety and efficacy of Sofalcone for the treatment of digestive ulcers. CHBP also stated that the trials will be conducted in six hospitals throughout China and are expected to be completed within one year.

About China Biopharmaceuticals Holdings

China Biopharmaceuticals Holdings, Inc (CHBP) is a research driven pharmaceutical company dedicated to the discovery, development, manufacturing and marketing of small and large molecule pharmaceutical products, including medicines, vaccines, and active pharmaceutical ingredients for various categories of diseases. CHBP's product portfolio includes 260 drugs already approved for manufacturing and marketing by the Chinese State Food and Drug Administration (SFDA). CHBP also has submitted 15 drug applications to the SFDA for its review during the calendar year of 2006. CHBP is a U.S.-listed public company with operating subsidiaries and senior management based in China. For further information, please visit our website at http://www.cbioinc.com.

Safe Harbor Statement

The statements contained herein that are not historical facts are "forward looking statements" within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as "believes," "expects," "may," "will," "should," or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In particular, our statements regarding the potential growth of the markets are examples of such forward- looking statements. The forward-looking statements include risks and uncertainties, including but not limited to, general economic conditions and regulatory developments, not within our control. The factors discussed herein and expressed from time to time in our filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed or implied by such statements. The forward looking statements are made only as of the date of this filing, and we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

China Biopharmaceuticals Holdings, Inc.
http://www.cbioinc.com

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.

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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

Cincinnnati Scientists Pursue New Target For Asthma Treatment

Cincinnati scientists have found further evidence that certain defensive white cells in the body cause or play a major role in the symptoms experienced by asthma patients.

Their findings, scientists say, could lead to the identification of a new treatment "target" to help the estimated 17 million asthma sufferers in the United States.

The scientists, at the University of Cincinnati (UC) Academic Health Center and Cincinnati Children's Hospital Medical Center, report their results in the Proceedings of the National Academy of Sciences.

Working with genetically altered mice, the Cincinnati researchers studied a group of cells called eosinophils. Originally evolved to defend the body against parasite infection, a problem no longer common in the Western world, eosinophils are known to accumulate during allergic responses--and especially in mucous in the lungs of asthma patients.

"Researchers have been looking at the role of eosinophils in asthma for decades," says research associate and first author Patricia Fulkerson, PhD. "Since people in the Western world don't have parasites in their guts to the extent they used to, the question is what eosinophils do now?"

"Previous studies linking eosinophils to asthma were done in single models," Fulkerson explains. "We increased the power of our study by looking at multiple models, and by doing that we show a strong role for eosinophils in mucous production in asthma."

The researchers, led by Professor Marc Rothenberg, MD, PhD, of UC College of Medicine and Cincinnati Children's Hospital Medical Center, also showed that eosinophils contribute to the recruitment of the immunity-regulating proteins known as cytokines, a process that allows mucous to accumulate in the lung.

"Previously most scientists looked at one model at a time--eliminating as many eosinophils as possible, inducing each model with asthma, and then watching what happens in an allergic response," Fulkerson explains. "Using just one model, however, it's difficult to determine the role of eosinophils versus that model's own genetic strategy."

So instead of a single model, Rothenberg, Fulkerson and their colleagues used three different ones. They studied one mouse model in which eosinophils don't develop from bone marrow, as they should, and two models in which eosinophils remain in the blood stream instead of rallying into the lung tissue to protect against asthma.

They then looked at the characteristics that all three models had in common so they could attribute any alteration in their appearance (or phenotype) to eosinophils, and not to that particular model's genetics.

In the absence of eosinophils, the researchers report, they found that allergen-induced mucous production dropped in all models, suggesting that "eosinophils play a big role in mucous production in response to an allergen challenge."

The researchers also report that eosinophils alter the lungs' "micro environment" by stimulating production of the signaling cytokines. Involved in triggering the body's immune defense mechanism to take action against infection, cytokines are responsible for almost all the characteristics of asthma.

"If cytokines are produced in the lungs, you'll end up with asthma," says Fulkerson. "But we found in eosinophil-free models that the cytokines that together produce almost all the visible symptoms of asthma--known as IL (interleukin) 4 and IL 13--were markedly reduced.

Having shown that eosinophils play an important part in mucous production and airway obstruction in asthma, the researchers' next goal was to determine how they actually do that.

Examination of mouse lung tissue revealed increased genetic activity associated with the characteristics of asthma: mucous, airway obstruction and hyperactivity.

"We took two of these models and looked at changes in gene expression in the lung caused by eosinophils," says Fulkerson. "We only picked up the genes that were in common in both models, so we can say the changes were eosinophil dependent versus model dependent.

"So now we have this list of genes that are eosinophil dependent in an experimental animal model and we're identifying new pathways that have never been attributed to eosinophils before," Fulkerson adds. "Now we and other researchers will pursue this to learn exactly what eosinophils are doing to those pathways and to see how we can block their contributions to asthma.

Some of these genetic pathways were known to be important in asthma, says Fulkerson, but no one had previously attributed them to eosinophils.

"That's the exciting part," she says. "If we can prevent eosinophils from being activated, then perhaps we can develop new targets for treatment. The goal is to find new approaches to asthma, because although we can treat asthma symptoms fairly well, we're not so good at dealing with the long-term consequences.

"And this doesn't only involve asthma. There are a lot of other diseases, especially digestive diseases, in which we see high levels of eosinophils that don't belong there," Fulkerson says.

###

Also contributing to the research were Christine Fischetti, Melissa McBride, Lynn Hassman and Simon Hogan, all of Cincinnati Children's.

Contact: David Bracey
University of Cincinnati

Pilot Study Successful In Taming Allergic Reactions To Food

Children who were allergic to eggs were able to essentially overcome their allergy by gradually consuming increased quantities of eggs over time, researchers at Duke University Medical Center and the University of Arkansas for Medical Sciences have found in a small pilot study.

"Participants who took a daily dose of egg product over the two-year study period were able to build up their bodies' resistance to the point where most of them could eat two scrambled eggs without a reaction," said A. Wesley Burks, M.D., chief of Duke's Division of Allergy and Immunology and a senior member of the research team. "Egg allergies cause a significant decrease in quality of life for many people, so this study is exciting in that it brings us a step closer to being able to offer a meaningful therapy for these people."

Egg allergy is one of the most common food allergies among children in the United States, Burks said. Just how many children are allergic to eggs is unclear, but the National Institute of Allergy and Infectious Diseases estimates that 6 percent to 8 percent of children have some type of food allergy. Most children outgrow egg allergy by age 5, but some people remain allergic for a lifetime.

The findings are reported in an advance online edition of the Journal of Allergy and Clinical Immunology and will appear in the journal's January 2007 print edition.

The study was funded by the National Institutes of Health and the two universities.

The study is the first in a series of studies on food allergy "desensitization" that are under way at Duke and the University of Arkansas. The goal, Burks said, is to offer food allergy sufferers protection from accidental ingestion of items that provoke reactions and, eventually, to induce complete or near-complete tolerance to those items.

Burks and his colleagues modeled the study on a commonly used method for treating seasonal allergy sufferers to alleviate symptoms. In this approach, called immunotherapy, physicians give patients shots containing small amounts of the troublesome allergen in an effort to build their tolerance to it. The therapy works on a cellular level to alter specific immune system cells, called lymphocytes, that play a part in orchestrating allergic reactions and to increase the immune system's production of antibodies that attack and neutralize allergens, Burks said.

The seven subjects in the study, who ranged from 1 to 7 years of age, had a history of allergic reactions, including hives, wheezing and vomiting, when they consumed eggs or egg products. For safety's sake, none of the children enrolled had previously experienced a life-threatening allergic reaction, Burks said. As an extra precaution, the subjects received a supply of epinephrine, which is commonly used to treat breathing problems that can occur with food allergy.

Instead of receiving shots, as seasonal allergy sufferers do, the subjects were given small doses of powdered egg orally, mixed in food. "We started the subjects with a very small concentration of egg product -- the equivalent of less than one-thousandth of an egg -- and then we increased the dose every 30 minutes for eight hours in order to determine the highest dose that each subject could tolerate," Burks said.

The subjects consumed the first doses in the study clinic. The researchers then gave the children's parents or caregivers a supply of egg product, allocated into the tolerated doses, which the subjects consumed daily at home, mixed with other foods.

The children returned to the clinic every two weeks. At each visit, the researchers increased the subjects' dosages until they reached the equivalent of one-tenth of an egg, Burks said. The children then continued to take this "maintenance dose" daily for the duration of the study.

Over time, the children showed both an increase in tolerance to eggs and a decrease in the severity of their allergic reactions, Burks said. At the end of the study period, most of the children could tolerate two scrambled eggs with no adverse reactions.

The researchers now are conducting two follow-up food allergy desensitization studies, Burks said. In one study, subjects receive higher doses of egg to see if this will further reduce their sensitivity or even neutralize the allergy altogether.

The second study focuses on children who are allergic to peanuts, to see if the desensitization approach can build their tolerance and decrease the severity of their reactions. Peanut allergy, which can be life-threatening, affects approximately 1 percent of children under age 5, and its incidence has been on the rise over the past 15 years, according to Burks. Studies have shown that about 20 percent of children with egg or milk allergy will go on to develop a peanut allergy.

Other members of the research team were Ariana Buchanan, Todd Green, Pamela Steele, Laurent Pons and Laurie Lee of Duke and Amy Scurlock, Lynn Christie, Karen Althage and Rick Helm of the University of Arkansas.

Contact: Lauren Shaftel
Duke University Medical Center

Christmas Allergies Can Make The Holidays Anything But Fun

As Christmas draws closer, winter allergies are once again on the rise. According to a recent survey, (3 out of 4) adults experience an increase of allergy attacks including headaches, eye irritation and sinus congestion from Thanksgiving through New Year's Day.

??The survey was conducted by SiCap Industries, makers of the world's first hot pepper nasal spray known as "Sinus Buster". With more than 500,000 regular customers, Sinus Buster has become a strong leader in the natural health industry.

??"We sent questionnaires to several thousand customers randomly. About 1200 surveys were returned. Each survey concentrated specifically on allergies during the holiday season. We couldn't believe how many of our customers had Christmas allergies," says Wayne Perry, president of SiCap Industries.

??Results showed (75%) of surveyed respondents complained of increased allergy symptoms during the holiday season.

??There are many causes for so-called "Christmas Allergies" including molds, artificial scents, and foods. While many people blame live Christmas trees for symptoms, allergies to evergreens are usually caused by molds growing naturally on trees. Artificial trees aren't much better if they are stored in areas where mold can grow throughout the year. The same holds true for ornaments and other decorations that are packed away yearly.

??To avoid mold contamination, store decorations in dry temperature controlled areas, and seal the cartons tightly. When unpacking, open cartons outside or in the garage, and allow them to air out for 24 hours before bringing them into the living area.

??Another trigger can be scented candles and other artificially scented decorations. Many people are also allergic to pine scented aerosol sprays used to add aroma to artificial trees.

??Increased alcohol consumption during the holidays is another cause. Alcohol is a major trigger for a variety of headaches and sinus problems. The same goes with certain foods. Moderation is the key as well as knowing which foods to avoid.

??The survey also drew feedback concerning SiCap's line of Sinus Buster Capsaicin nasal sprays. An astounding (96%) of respondents reported that Sinus Buster relieved their seasonal allergies better than any other product they had previously tried.

??"It was a pretty close race between the classic formula and our allergy formula, but the allergy formula is designed to prevent symptoms in addition to relieving them," Perry explains.

??The Sinus Buster Allergy formula uses a combination of Capsaicin and Nettle extract to relieve allergy symptoms naturally. A couple squirts instantly attacks the worst symptoms including headaches. According to the manufacturer, Sinus Buster lets you enjoy all the tastes and smells of Christmas without the worry of allergy attacks, and it makes a great stocking stuffer.

??http://www.sinusbuster.com

New Journal Focuses On Lifestyle Health

With more and more Americans battling maladies such as allergies, anxiety, depression, cardiovascular disease, hypertension, and weight management issues, it's clear that everything we do - from what we eat to how much exercise and sleep we get - directly impacts our health. The need for the latest research and information in these fields is apparent.

As a result of this dynamic and growing field, SAGE is launching its newest publication, the American Journal of Lifestyle Medicine (AJLM). The bi-monthly journal, which launches its first issue in January, will feature peer-reviewed papers exploring lifestyle medicine's many disciplines, and is geared at helping primary care providers guide their patients to lead healthier lives.

"While there are many factors that contribute to health problems, one common denominator is that they are all associated with a person's daily habits and actions," commented James M. Rippe, MD, Editor-In-Chief of AJLM. "With more research in this field than ever before, healthcare providers are not only educating their patients about disease management, but should also be advising them on how to maintain their health through proper lifestyle choices. That's what AJLM is all about."

"I expect the American Journal of Lifestyle Medicine to become an authoritative voice in the field for caregivers because it's a unique publication," said Ron Epstein, SAGE Director, Controlled Circulation Publications. "It's not only edited by the leader in the lifestyle medicine field, renowned cardiologist Dr. Rippe; it also boasts an outstanding editorial board with extensive expertise in the disciplines covered by the Journal. The AJLM is the latest in SAGE's growing number of journals in the fields of science, technology, medicine and social sciences."

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To find out more about the American Journal of Lifestyle Medicine, visit the journal's website at http://ajlm.sagepub.com/.

About SAGE
SAGE Publications is a leading international publisher of journals, books, and electronic media for academic, educational, and professional markets. Since 1965, SAGE has helped inform and educate a global community of scholars, practitioners, researchers, and students spanning a wide range of subject areas including business, humanities, social sciences, and science, technology and medicine. A privately owned corporation, SAGE has principal offices in Los Angeles, London, New Delhi, and Singapore.

http://www.sagepublications.com/

Contact: Ron Epstein
SAGE Publications

Infants Wheeze Less In Homes With Multiple Dogs

Living in a home with multiple dogs may help reduce an infant's risk for developing wheezing in the first year of life, according to new research from the University of Cincinnati (UC).

Cincinnati researchers, led by David Bernstein, MD, have found that infants living in homes with high levels of endotoxins (bacterial contaminants) and multiple dogs were more than two times less likely to wheeze than other infants.

They found that wheezing was not associated independently with either dog or cat ownership or high levels of indoor endotoxins; however, high endotoxin exposures in homes that also had multiple dogs resulted in less wheezing.

"Our research presents evidence that pet ownership offers a protective effect against development of lower respiratory symptoms in young children," adds Bernstein.

The UC-led team's findings conflict with earlier studies suggesting exposure to high endotoxin levels or pet ownership can protect against an increased risk for future allergic diseases, the UC team reports in the December edition of the Journal of Allergy and Clinical Immunology.

"Exposure to high endotoxin levels in the home may not be an important determinant of aeroallergen sensitization during infancy," explains Bernstein, professor of immunology and senior author for the study. "We do not yet understand how and why exposure to high levels of bacterial endotoxin and multiple dogs in the home exert a protective effect in these high-risk infants from wheezing early in life."

Endotoxins are natural compounds secreted from pathogens (disease-causing agents) like bacteria that are commonly found in the intestines and feces. Scientists believe that endotoxins can stimulate our immune systems in many different ways.

"Our bodies are programmed to produce allergic responses early in life," Bernstein explains, "but there are environmental factors like bacterial endotoxins that may modify the immune system and block development of allergies early in life."

The UC-led team analyzed the effects of pet ownership (cats and dogs) and endotoxin exposure in 520 infants enrolled in the Cincinnati Childhood Allergy and Air Pollution Study (CCAAPS) who were identified as being at greater risk for developing allergies because at least one parent had known allergies.

The CCAAPS, funded by the National Institute of Environmental Health Sciences, is a five-year study examining the effects of environmental particulates on childhood respiratory health and allergy development.

Researchers collected dust samples from the infants' homes to measure endotoxin levels. They also determined the number of siblings and gathered information about the home, including the presence of mold and second-hand smoke. Environmental and food allergy development was monitored through annual skin prick tests.

Previous studies have addressed the role of pet ownership in childhood allergy development; however, findings have been inconsistent, according to Bernstein. Until now, it was unclear whether animal ownership, endotoxin exposure or a combination of the two resulted in wheezing. Bernstein says further research is needed to determine if these early protective effects have long-term benefits.

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Collaborators in this study include Manuel Villareal, MD, of Cincinnati Children's Hospital Medical Center and UC colleagues Paloma Campo, MD, Hapinder Kalra, MD, Linda Levin, PhD, Tiina Reponen, PhD, Rolanda Olds, Zana Lummus, PhD, Seung-Hyun Cho, PhD, Gurjit Hershey, MD, PhD, James Lockey, MD, Sherry Stanforth and Grace LeMasters, PhD, principal investigator of the CCAAPS.

Contact: Amanda Harper
University of Cincinnati

Alimera Sciences Receives FDA Approval To Market Alaway(TM) OTC For Up To 12 Hours Of Eye Itch Relief

Alimera Sciences Inc., an ophthalmic pharmaceutical company founded just three years ago, today announced that the U. S. Food and Drug Administration (FDA) has approved its ophthalmic solution Rx-to-OTC-switch new drug application (NDA) for Alaway(TM) (ketotifen fumarate ophthalmic solution 0.025%). Alaway(TM), a multiple action eye anti-allergic, is Alimera's first NDA submission and the first to win approval. Indicated for the temporary relief of itchy eyes, Alaway(TM) will be marketed over-the- counter with the prescription strength active ingredient found in a prescription allergy eye drop.

An estimated 40 million people cope with itchy eyes associated with pollen, ragweed, grass, animal hair and dander -- particularly during the spring and fall months. Unlike over-the-counter anti-itch eye drop products currently available, just one dose of Alaway(TM) offers eye itch relief within minutes and lasts up to 12 hours. Other over-the-counter products currently available offer no more than four hours of relief and require four doses per day. Alaway(TM), with its unique property of being both an antihistamine and a mast cell stabilizer addresses itchy eyes, the number one complaint among eye allergy sufferers.

"Developing Alaway(TM), submitting the application and achieving FDA approval for a three-year-old company is, indeed, an accomplishment of which Alimera is tremendously proud," said Dan Myers, president and chief executive officer of Alimera Sciences. "The FDA's approval of Alaway(TM) marks a milestone in Alimera's overall strategy to consistently deliver innovative solutions to patient needs.

Alimera initially filed the NDA for Alaway(TM) in February of this year after completing a successful clinical study that showed it to be bioequivalent to Novartis' Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%). Alaway(TM), in a 10mL bottle, is expected to be available to consumers in time to provide prescription strength relief for the spring 2007 allergy season.

About Alimera Sciences Inc.

Alimera Sciences Inc., a venture backed company, specializes in the development and commercialization of over-the-counter and prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences' products address both the anterior (front) and posterior (back) segments of the eye. In August 2004, Alimera Sciences unveiled Soothe(R), the market's first multi-dose, emollient-based artificial tear product, and in October 2005 initiated a Phase III clinical trial to study diabetic macular edema (DME) patients treated using Medidur(TM) with fluocinolone acetonide, the company's pharmacologic treatment for DME.

Alimera Sciences Inc.
http://www.alimerasciences.com

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.

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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

Itch And Motivation To Scratch

Intense itching and the urge to scratch are symptoms of many chronic skin ailments. A new study conducted by Oxford University researchers has found that different reactions in the brain to two common allergy triggers -- allergens (pollen and dust) and histamine (allergy cells within the body caused by foods, drugs or infection) -- may shed some light on the itch-scratch cycle.

The Study

The study is entitled Itch and Motivation to Scratch: An Investigation of the Central and Peripheral Correlates of Allergen- and Histamine-Induced Itch in Humans. The research team was comprised of Siri G. Leknes, Susanna Bantick, Richard G. Wise and Irene Tracey, all of the Department of Physiology, Anatomy and Genetics, Oxford University, Oxford, UK and Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB), Clinical Neurology, Oxford University, Oxford, UK; and Carolyn M. Willis and John D. Wilkinson, both of the Department of Dermatology, Amersham Hospital, Amersham, UK.

The results of the study are published in the online edition of the Journal of Neurophysiology (http://jn.physiology.org/). The journal is one of the 14 scientific publications published by the American Physiological Society (APS) (http://www.the-aps.org/) every month.

Methodology Overview Laser Doppler Study

Twenty eight female volunteers were recruited for the study, of which 14 tested positive (atopic cohort) for type I allergens (grass pollen and/or house dust mite) and 14 did not (non-atopic cohort). Over three consecutive days the atopic cohort was challenged with either their specific allergen or histamine, along with the saline control group, by applying a skin prick to the forearm. Non-atopic subjects were challenged with histamine and saline on two consecutive days.

The subjects rated itch intensity continuously on a scale of 0 (no itch) to 10 (worst itch imaginable). Itch related skin blood flow changes for both groups were measured by laser Doppler. Data points from the laser Doppler were summated and mean values and standard deviations were calculated for each cohort.

fMRI Imaging Study

Sixteen males and females comprised a second group of atopic and non-atopic individuals. As part of the study participants laid down in an fMRI (functional magnetic resonance imaging) scanner. A standard whole-brain gradient echno-planar imaging sequence was used to obtain the functional scans. Sixty seconds after participants reclined they received a skin challenge to the toe area.

The volunteers were presented with a screen showing a simplified itch rating scale of 0 (no itch) to 5 (worst itch imaginable). Subjects pressed a button to rate the itch they felt when the scale was presented. Following the test each subject's mean rated itch intensity was computed and the differences between types of itch were explored using a t-test. Correlations between mean itch ratings in the two groups were investigated using SPSS.

Results

After examining the data obtained at the different itch sites, the different itch scales, and the gender differences between the study populations, the researchers determined that extensive commonalities existed between allergen- and histamine-induced itch. Among them was the extensive involvement of the brain's motivation circuitry in response to both types of itches.

Researchers also observed differences, including:

* allergen-induced itch intensity ratings were higher compared to histamine;

* perception of itch and changes in blood flow were significantly greater when allergen induced;

* itch intensity perception and the changes in blood flow occurred significantly later in response to allergen, and while the sensations took longer to appear, they were perceived to exist for significantly longer periods;

* itch elicited by allergens activated different parts of the brain, specifically the supplementary motor and posterior parietal areas; and

* the differences found in the orbifrontal regions of the brain imply a compulsion to so something (i.e., scratch) that is very strong in the allergen group. This is presumably due to the heightened intensity of the itch. There are similarities to the activity in this area of the brain and other disorders that display compulsive behavior. This might help to explain why eczema sufferers scratch to the point of harm because they are compelled to do so and cannot help themselves.

Conclusions

While there are extensive commonalties between allergen- and histamine-induced itch, perceptions about the intensity and the parts of the brain that are activated by allergens differ when compared to histamine. As a result, mothers who admonish their children to stop itching may now be rightly told "I can't." For mold and grass-related itches, it appears that science is on their side.

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Contact: Donna Krupa
American Physiological Society

Why Altitute Can Make You Sick - What You Can Do About It

Every breath you take isn't the same. Board a plane in New York and step off hours later in Aspen, or Chamonix or Lhasa, and, chances are, the plane food isn't what's turning your stomach. It's the change in altitude.

Altitude sickness can be the Achilles' heel of adventure travelers because there is no way to prepare for it before you go and no quick remedy to overcome it once you've arrived. It can choose its victims with amazing unpredictability, sometimes leaving the fittest gasping for breath while allowing the weakest and flabbiest to breathe freely. Age, gender and ethnicity also seem to make no difference as to who is affected.

"The only surefire way to minimize the effects of altitude change is to acclimatize," says Dr. Ronald G. Crystal, chair of genetic medicine at Weill Cornell Medical College, and chief of pulmonary and critical care medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. An experienced mountaineer and ice climber, Dr. Crystal has personally experienced the effects of altitude sickness. "Travel to a high-altitude location slowly, or give yourself a few days to adjust, once there. But nowadays this doesn't always happen. People have limited time. They fly into 8,000 feet and take a chairlift the next day to 10,000."

Interestingly, the cause of altitude sickness isn't the percentage of oxygen in the air, which remains at about 21 percent worldwide. The difference is how closely oxygen molecules are squeezed together by barometric pressure. Descend toward sea level and barometric pressure increases; ascend upward and the reverse happens. This is why a breath in Seattle feels more satisfying than one in, say, Machu Picchu.

"Stay below 15,000 feet and altitude sickness can be troublesome, but generally not life-threatening," says Dr. Crystal. People may experience nausea, headache, fatigue and shortness of breath, but within a few days, their bodies usually acclimatize and symptoms subside. Keeping hydrated and staying away from alcohol and barbiturates, such as sleeping pills and tranquilizers, will help speed the process toward acclimatization.

However, above 15,000 feet, the consequences of altitude sickness are more serious and can even be fatal. The primary danger is that the thin air will allow fluid to seep from capillaries and result in either High Altitude Pulmonary Edema (H.A.P.E.) or High Altitude Cerebral Edema (H.A.C.E.). With H.A.P.E., fluid leaks into the sacs of the lungs, making breathing difficult. A person can literally suffocate from within. With H.A.C.E., fluid leaks into the brain; the brain swells and is pushed against the skull.

Both conditions are extremely serious, and anyone with symptoms needs to get down to a lower altitude immediately. Those with H.A.P.E. have difficulty breathing; often cough up blood; and can make a crackling sound when they breathe. Those with H.A.C.E. are likely to lose coordination; have vision problems; or become irrational.

There are medicines that can help with both mild and severe altitude sickness, but the only certain remedy is to move to a lower altitude. For medication, Acetazolamide (Diamox) can help relieve the symptoms of mild altitude sickness. The drug encourages the kidneys to excrete bicarbonate, the base of carbon dioxide, which makes the blood more acidic and signals the lungs to breathe more frequently. Acetazolamide has some side effects, though: mainly, frequent urination; tingling in fingers and toes; and giving an unpleasant taste to carbonated beverages.

For more severe altitude sickness, physicians recommend Dexamethasone and Nifedipine. Dexamethasone is used to treat H.A.C.E. by reducing brain swelling and bringing down pressure within the skull. The other drug, Nifedipine, can lower pressure in the pulmonary artery and is therefore used to treat H.A.P.E. Reducing pressure in the pulmonary artery reduces the risk that fluid will seep out through capillaries and flood the lungs.

"One last thing," says Dr. Crystal, whose mood has now turned from scientific to humorous. "In the movie 'Vertical Limit' where the climber with H.A.P.E. takes a syringe of medication and plunges it into his heart. You don't want to do that."

Science Briefs is an electronic newsletter published by the Office of Public Affairs that focuses on innovative medical research and patient care at Weill Cornell Medical College.
http://www.med.cornell.edu/science

Researchers Barcode DNA Of Vast Fungi Collection

In the storerooms of a Venice, Italy, museum, a University of California, Berkeley, scholar and Italian experts are at work on a rare collection, but the objects aren't Renaissance paintings or the art of ancient glassblowers. Instead, the team is collecting samples from the largest and best preserved collection of fungi in Italy to create an unprecedented DNA database.

These 28,000 samples of fungi that represent 6,000 species - many of which are quite rare - are housed at the Venice Museum of Natural History, a partner with UC Berkeley for this ambitious project. The collection also is one of the largest in Europe.

The project was publicly announced in Italy at the prestigious Venetian Institute of Sciences, Letters and Arts.

"We are building up a huge molecular database that will be available to the entire scientific community," said Matteo Garbelotto, UC Berkeley adjunct associate professor of ecosystem sciences and principal investigator of the project. "In addition to aiding research on the productivity of forests and agricultural ecosystems, this database will greatly aid the diagnosis of plant diseases."

Fungi are a kingdom of organisms that include yeasts, mushrooms and mold. They are essential to most terrestrial ecosystems, channeling nutrients in the soil and making them available for the growth of plants, including trees and agricultural crops. "Without fungi, there would be no forests," Garbelotto pointed out.

A large number of fungi are also plant pathogens and cause serious diseases of crops and trees, especially when transported to new areas of the world through the global trade of goods and movement of people. In addition, some species of fungi can lead to human illness, including pneumonia, skin infections, allergies and asthma.

Garbelotto is perhaps best known for his work in the identification of Phytophthora ramorum, the fungus-like plant pathogen that made its way from Europe to the United States. The pathogen is responsible for sudden oak death, the disease that has caused widespread dieback of tanoaks and coast live oaks in California and southwest Oregon.

"In the case of exotic plant diseases, DNA information may be used, as it is in criminal forensics, to identify possible culprits and to understand how they were introduced," said Garbelotto. "This provides governments with pivotal information needed to avoid repeated introductions of pathogens."

Garbelotto is working with Italian mycologist Giovanni Robich and Luca Mizzan, curator of Marine Biology at the Venice Museum of Natural History, to sort through the samples in the museum, which are being sent to Garbelotto's lab at UC Berkeley for DNA sequencing and analysis.

The Venice Natural History Museum is part of the Musei Civici Veneziani, a network of 11 museums in Venice. It is housed in the Fontego dei Turchi, a Byzantine-style palace on the Grand Canal that dates back to the 12th century. Before it was established as a museum in 1923, it had served as a trading depot for Turkish merchants.

"Often museums are seen as places where people just go and see things," said Garbelotto, who is doing this work during a sabbatical leave from UC Berkeley. "This shows that museums are actually involved in cutting-edge research. Providing a database of this scope is pretty novel."

Museum curator Mizzan said the museum's vast collection of fungi got a kick start when the Venice Society of Mycology formed in the late 1980s to monitor the mycological flora in the Lagoon of Venice and surrounding areas. The collected samples represented over 1,200 species of fungi and formed the foundation of the museum's present collection.

Garbelotto noted that the relatively young age of the samples has been critical to obtaining good quality tissue for DNA analysis. The samples come from throughout Europe, with a significant number representing species found elsewhere in the world.

Rather than sequencing the entire genome of each species, the researchers are focusing on a non-coding region of the ribosomal DNA that is known to be unique in each species. The length of the region varies from around 450 base pairs to 900 base pairs, depending upon the taxa from which it is sampled.

"If you're going to cross-compare species, you've got to amplify the same region," said Sarah Bergemann, the post-doctoral researcher in ecosystem science who is heading the lab analysis work at UC Berkeley. Bergemann is working with Amy Smith, staff research associate at Garbelotto's lab, to process the samples Garbelotto sends from Italy.

"This will be important for people who study the evolutionary characteristics of fungi," said Bergemann. "They'll be able to use our database for cross comparisons. It's also useful for people who study species distribution. For example, if you want to figure out how some species are related to one another, and you know something about their taxonomy, you can go back to their DNA to see if the morphological characteristics match their molecular code."

Without the DNA fingerprint, researchers traditionally need to wait for fungi to fruit or mushroom to identify them. "This can be very limiting because mushrooms are only produced seasonally, with some species only fruiting once every several years," said Garbelotto. "The database we are creating will allow people to identify the fungi present in plants, in the soil and in the air at any time."

The project, which began in April, is expected to be completed by the end of 2007. "We do not know of any similar project in Europe, at least of this dimension," said Enrico Ratti, the museum's scientific director.

"The importance of this project is in the cooperation between different subjects, namely private collectors, a private association, a public municipal museum and a foreign university," said Giandomenico Romanelli, director of the Musei Civici Veneziani. "We think that this is an exemplar model, to be followed in subsequent projects. Furthermore, in our philosophy, natural science collections are public goods that everybody belonging to the scientific community should be able to take advantage of."

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Contact: Sarah Yang
University of California - Berkeley

Cincinnati Children's Researchers Publish Positive Findings From Clinical Study Of Investigational Treatment For Debilitating Allergic Disorder

Cincinnati Children's Hospital Medical Center, a recognized leader in pediatric research dedicated to changing the outcomes for children, today announced the publication of positive results from a phase 1/2 clinical trial evaluating mepolizumab, a humanized antibody to interleukin 5 (IL-5), for the treatment of eosinophilic esophagitis (EE). EE is an allergic inflammatory reaction characterized by the accumulation of large numbers of eosinophils (a type of white blood cell associated with allergic reactions) in the esophagus that leads to vomiting and difficulty in swallowing.

"Previous results suggested a key role for interleukin 5 in the accumulation of eosinophils in the esophagus and provided a strong rationale for evaluating an anti IL5 antibody as a potential therapy for EE," said Marc Rothenberg M.D., Ph.D., director of the Division of Allergy and Immunology at Cincinnati Children's Hospital Medical College. "With support of the CCHMC Translational Research Office, this study provided a strong proof of concept for the use of mepolizumab. This data has fueled the pharmaceutical industry to expand this clinical experience with the goal of providing patients with a meaningful and effective treatment option." The paper, published in the December issue of the Journal of Allergy and Immunology, describes positive results from an open-label phase I/2 study evaluating the safety and efficacy of mepolizumab in four adult patients with EE who had long term difficulty in swallowing and esophageal narrowing caused by chronic inflammation. Patients received 3 monthly infusions of mepolizumab without change in their current therapy and were monitored for 28 weeks.

At the conclusion of the study, analysis showed statistically significant reductions in several key indicators of disease including marked decreases in eosinophils in the peripheral blood and in the esophagus. In addition endoscopic examination of the esophagus showed improvements in three out of four patients. The treatment was generally well-tolerated, and all patients reported a better clinical outcome and improved quality of life.

"Cincinnati Children's has long been at the forefront of research into eosinophilic disorders and its commitment was recently underscored by the establishment of the Cincinnati Center for Eosinophilic Disorders," said Ellyn Kodroff, President, CURED: Campaign Urging Research for Eosinophilic Disorders. "Clinical results like this provide important hope for relief from the horrific effects of this condition for patients and their families."

EE is part of a series of chronic and debilitating gastrointestinal disorders associated with allergies that are characterized by elevated levels of eosinophils that attach to the intestinal tract leading to abdominal pain, nausea, vomiting and difficulty swallowing. Patients suffering from these disorders frequently must adhere to a strict diet or acquire nutrients via a feeding tube directly inserted into the stomach; and many endure nausea, abdominal pain and vomiting after every meal. Newly recognized as a disease, data shows a dramatic increase in the diagnosis of EE. It is estimated that at least one in 1,500 people suffer from some form of the disorder.

Allergic disorders are a major public health problem, affecting 50 million people in the United States. Nine million children under 18 have been diagnosed with asthma, and asthma rates in children under the age of five increased more than 160 percent from 1980-1994.

About Cincinnati Children's Hospital Medical Center

Cincinnati Children's Hospital Medical Center, a recognized leader in pediatric research, is dedicated to changing the outcome for children throughout the world. Cincinnati Children's ranks second among all pediatric institutions in the United States in grants from the National Institutes of Health. It has an established tradition of research excellence, with discoveries including the Sabin oral polio vaccine, the surfactant preparation that saves the lives of thousands of premature infants each year, and a lifesaving rotavirus vaccine for hundreds of thousands of infants around the world. Current strategic directions include the translation of basic laboratory research into novel therapeutics for the treatment of disease, and furthering the development of personalized and predictive medicine for children.

Cincinnati Children's Hospital Medical Center
http://www.cincinnatichildrens.org/

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

Gender And Obesity Key Factors In Habitual Snoring

A new study confirms that male gender, obesity, and weight gain are key determinants of habitual snoring in the adult population. In 1981, Australian researchers surveyed 967 nonsnoring adults aged 25 to 74 years regarding their gender, age, respiratory/allergy symptoms, and habits related to snoring, smoking, and alcohol, tea, and coffee consumption. Body size measurements and lung function were also measured. Participants completed a follow-up survey 14-years later. Overall, 13 percent of participants became habitual snorers at the 14-year follow up. Results indicated that male gender and baseline body max index (BMI) were significant predictors of developing habitual snoring. Change in BMI over the follow-up period, development of asthma, and initiation of smoking were additional independent risk factors for the development of habitual snoring. This study appears in the December issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

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Newsbriefs from the journal Chest, December 2006

Contact: Jennifer Stawarz
American College of Chest Physicians

Allergy Drug Slows Pancreatic Tumor Growth In Preclinical Studies

An anti-allergy drug in use for more than 40 years significantly reduced tumor growth in animal models of human pancreatic cancer and also increased the effectiveness of standard chemotherapy, say researchers at The University of Texas M. D. Anderson Cancer Center.

In the Journal of the National Cancer Institute, the investigators report that combining the drug, cromolyn, with chemotherapy was nearly three times better at retarding growth of pancreatic tumors in mice compared to the chemotherapy agent gemcitabine alone.

The finding may lead to a treatment advance for patients with pancreatic cancer, believed to be the most lethal of all cancers. More than 95 percent of patients diagnosed with the disease die from it, and half of those deaths occur in the first six months after diagnosis.

"Our goal is to offer longer life to these patients, and the combination of these two agents may well do that," says the study's lead author, Craig Logsdon, Ph.D., a professor in the Department of Cancer Biology.

Logsdon is working with physicians at M. D. Anderson to prepare for a clinical trial. Although cromolyn is off patent and widely available, it has been used only as a topical agent (through an inhaler, nasal spray and eye drops), so the research team is studying how to deliver the drug internally.

"Cromolyn seems to reduce survival mechanisms in pancreatic cancer cells enough that when gemcitabine is added, the chemotherapy is more effective," Logsdon says. "This is good, because chemotherapy normally has very little effect in patients."

The JNCI study demonstrates in mouse models of human pancreatic cancer that the cromolyn-gemcitabine combination reduced cancer growth by 85 percent compared to control animals, Logsdon says. "Cromolyn used alone actually had a good effect on reduction of tumors compared to control animals, which surprised us," he adds. It reduced tumor growth by 70 percent, compared to growth reduction of 50 percent when gemcitabine was used as a single agent, compared to control animals.

No one knows exactly how cromolyn works to control allergies. However, Dr. Logsdon has found that cromolyn can bind a specific protein produced by cancer cells and block that protein's ability to interact with a receptor that stimulates cancer cell growth, survival, and spreading. The relationship between how the drug controls allergies and its anti-tumor effect in pancreatic cancer remains unclear. "It may be possible that cromolyn has more than one target that influences cancer," he says.

Logsdon discovered the cancer-stimulating protein, determined how it triggers tumor growth and spread, and identified cromolyn as an inhibitor. "Through serendipity and basic science sleuthing we may now have something that helps patients," he says.

The study culminates Logsdon's five-year search for an agent to treat pancreatic cancer.

Logsdon searched for genes that produced proteins secreted only by cancer cells, which would then loop around and act on the cancer cell through a receptor on the cell surface. "That way, we could have two potential drug targets - the secreted protein and the receptor," he said.

Out of a long list of such genes, Logsdon and his research team selected one called "S100P" because it is a member of the large S100 gene family, some of which produce secreted proteins and some of which are associated with other cancers. Further work showed that S100P over-expression was very specific to pancreatic cancer; the protein was not found in normal pancreatic cells. "It is important to embryonic development, but no one knows its physiological role in adult biology," he says.

By using gene-silencing techniques, Logsdon found that when the protein is disabled, cancer growth is slowed. "S100P plays a role in tumor development because it causes cancer cells to grow faster, survive better, and be more invasive," he says.

Logsdon found that S100P interacts with a receptor known as "RAGE" which also plays a role in diabetes, arthritis and Alzheimer's disease. If RAGE is blocked in pancreatic cancer cells, addition of synthetic S100P to the tumor does not accelerate growth.

While Logsdon was defining S100P in pancreatic cancer, a Japanese research team working on allergies ran an experiment to see which proteins "stuck" to anti-allergy drugs, including cromolyn. Several members of the S100 family did. Logsdon then discovered that the drug also bound to S100P. He applied cromolyn to laboratory pancreatic cancer cells, and found that tumor growth was slowed. A larger effect was seen when the chemotherapy agent gemcitabine was combined with cromolyn.

Logsdon suspects that cromolyn may have other anti-tumor effects, a theory which he is currently testing. "For me this is pretty thrilling," he says. "In a relatively short time, we have gone all the way from discovering a molecule to preparations for a clinical trial."

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The study was funded by the Lockton Endowment and the M. D. Anderson Cancer Center Pancreatic SPORE grant from the National Cancer Institute. Working with Logsdon were M. D. Anderson researchers Thiruvengadam Arumugam Ph.D. and Vijaya Ramachandran, Ph.D.

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