Triway High School News and Expo

three (one votes)

Healthcare Prof:

The Consumer Award is intended for products that will generally benefit allergy sufferers and improve their state of health and wellbeing. The award is given entirely on the basis of consumer opinion, and evidence of this should be supplied from a minimum of 25 consumers.

Their opinions can cover anything from durability and ease of use right through to value for money and perceived benefit.

This evidence and a product sample will also be carefully assessed by a panel of experts from Allergy UK to verify the consumers opinions. The following products have received the Consumer Award:

Bio-Life International Ltd
Petal Cleanse Anti-Allergen Lotion (Denatures pet allergens)
Telephone:
01608 686 626
E-mail:
sales@bio-life.co.uk

RDi International
(The Home Valet Company)
Baked-On Mini Wax Dusters
Telephone:
0800 074 7788

Enviro Products
E-Cloths (Chemical free cleaning cloths)
Web Site: http://www.e-cloth.com
Telephone:
01892 752199

York Test
FoodScan Range (To include Indicator Test 42, 76 & 113 Food Intolerance Test Kits)
Web Site: www.allergy.co.uk
Telephone:
0800 074 6185

Bottlegreen Drinks Co.
Tiger White – Dairy/Soy Free Milk Alternative
Web site: www.tigerwhitedrinks.com
Telephone:
01453 874 000

Allergy UK is the operational name of the British Allergy Foundation, a charitable company limited by guarantee and registered in England and Wales. Company No: 4509293. Charity No: 1094231.

http://www.allergyfoundation.com

3.4 (5 votes)

Healthcare Prof:

3 (2 votes)

Most people can eat a wide range of food without any problems. But there’s a small group of people allergic to particular foods or ingredients in foods. The allergic reaction can range from minor skin irritations to serious allergic shocks.

An allergy means that a person’s immune system shows an excessive defence reaction to substances which in themselves are harmless – it has “forgotten” how to distinguish between harmful and harmless substances.

The symptoms of an allergic reaction vary considerably. The most frequent complaints occur shortly after eating, either while in the form of prickling or swelling in the mouth or throat, or being a skin rash.

Allergic reactions inside the gastro-intestinal tract, such as nausea, vomiting, diarrhoea or constipation, occur in relatively few cases.

More seldom still are shock reactions (anaphylactic shock). These can bring about circulatory failure, which must be treated immediately by a doctor.

A food allergy is 1 thing – a food intolerance is another. A food intolerance can produce symptoms very much like those of food allergy, but the immune system is not involved in these reactions within the same way. If you have a food intolerance, your body is unable to digest a certain kind of food or some ingredient in a food, e.g. because the required enzyme is absent or inactive.

Since the digestive system is involved in most cases, the principal symptoms of food intolerance (such as lactose intolerance – link to the same topic) are flatulence, gastro-intestinal pains and diarrhoea.Allergies and food intolerances can appear in many different degrees of severity.

Under certain circumstances it is urgently advisable to consult a doctor specialised in allergology, who will be able to determine the exact causes and draw up an individual diet plan together with a dietitian.

www.eufic.org
www.foodexperts.net

Healthcare Prof:

Bethesda, Maryland – Malaria research scientists from around the globe have published new insights into the international burden of malaria and what can be done about it. The new data are presented in a supplement to the American Journal of Tropical Medicine and Hygiene titled “The Intolerable Burden of Malaria II: What’s New What’s Needed”, released on September 9, 2004.

“The global burden of malaria is staggering and intolerable”, says National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D. “The articles in this important publication help to quantify this burden and describe what is being done – and what is needed – to reduce the human suffering and economic toll caused by malaria.”

“This supplement comes at a critical time when agencies around the world are working harder than ever to find new solutions to the seemingly intractable problem of malaria,” said Dr. Sharon Hrynkow, Acting Director in the Fogarty International Center (FIC), which led the development of the supplement on behalf of its partners. “Multilateral efforts, including the Global Fund for AIDS, TB and malaria, as well as national efforts will benefit from your information gathered in this supplement,” she added.

In the groundbreaking publication, available to scientists worldwide at no cost, it is reported that artemisinin-based combination therapy can significantly delay the development of malaria parasite resistance and are more effective than anti-malarial agents currently in use. New information on insecticide-impregnated bed nets designed to protect children, pregnant women, and newborns from the disease is also reported.

“This combination therapy is just one of several approaches in clinical development that is designed to prevent or lessen the onset of malaria and promote earlier recovery,” notes Dr. Kenneth Olden, director in the National Institute of Environmental Health Sciences (NIEHS). As many as 35 candidate vaccines are in clinical development, of which 16 are designed to prevent or minimize the onset of parasitemia, lessen febrile malaria attacks, and promote earlier recovery. Transmission-blocking vaccines, also called “altruistic vaccines”, prevent infectious sexual stage (sporozoite) development in the salivary glands of Anopheles mosquitoes and block the transmission of malaria by infected mosquitoes, thereby protecting larger communities.

Every year, malaria kills close to two million persons and is associated with close to five billion episodes of clinical illness throughout the world. More than 50 percent of the world’s population is exposed to the disease – an increase of close to 10 percent more than the past decade. Those living in the most economically deprived areas receive the worst care and suffer catastrophic economic consequences from their illness. Almost three percent of disability-adjusted life years (DALYs) are due to malaria mortality globally, 10 percent in Africa.

Only the second of its kind, the new supplement contains data contributed by malaria researchers from around the world, including many in malaria-endemic areas.

“The most successful malaria control programs over the past 100 years, within the Americas and Europe, and now in Africa and Asia, have been linked to strong research activities. New antimalarial drugs, insecticides, bed nets, and other methods to control malaria have come from field research within the swamps and other mosquito breeding areas, and the laboratories, clinics and hospitals from the United States, Caribbean, and southern Europe,” states Fogarty’s Dr. Joel Breman, 1 with the editors for the supplement. Now, a growing number of scientists from Africa, the area suffering the greatest toll from malaria, are more actively involved in combating this scourge compared to a few years ago. Their contributions to understanding the socio-cultural dimensions in the burden of malaria are vital to the development of effective interventions and improving understanding of how to deploy and facilitate access to those interventions.

Input for the supplement was derived from the Multilateral Initiative on Malaria (MIM) Pan African Conference, held in Arusha, Tanzania and hosted by the MIM, an alliance of organizations and people working together to maximize the impact of scientific research on malaria in Africa. The supplement was supported by the Fogarty International Center, the National Institute of Allergy and Infectious Diseases, the National Library of Medicine and the National Institute of Environmental Health Sciences from the National Institutes of Health and other partners.*

The new supplement, featuring 37 papers, was edited by Dr. Joel Breman, FIC, Dr. Martin Alilio, Academy for Educational Development (formerly from the Fogarty International Center), and Dr. Anne Mills, London School of Hygiene and Tropical Medicine. Featured papers while in the malaria supplement discuss the latest findings on relationships between malaria and other morbidities, including HIV in pregnant women; malnutrition; and neurological, cognitive, and developmental sequelae. The authors explore new antimalaria treatment methods, examine methods for calculating the global burden of disease and malaria, and assess the impact of mosquito transmission on morbidity and mortality. Approaches for determining the economic toll caused by malaria are examined; and the role of urban malaria, epidemics and social and economic burdens in impeding the development of cost effective, newer malaria control methods are analyzed. Featured papers also discuss the research agenda and other focused activities that help to define malaria’s toll on the world’s population. Full text with the journal supplement can be accessed by visiting http://www.ajtmh.org/content/vol71/2_suppl/index.shtml.

Researchers interested in receiving a hard copy from the journal supplement or the associated DVD should contact the FIC Communications Office at ficinfo@nih.gov or (301) 496-2075.

The National Institutes of Health (NIH), Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research, helping to lead the way toward important medical discoveries to improve people’s health. NIH investigates the causes, treatments, and cures for both common and rare diseases. Composed of 27 Institutes and Centers, each with its own broadly defined mission, NIH provides leadership and financial support to more than 210,000 scientists in every state and throughout the world. The NIH Web site may be visited at http://www.nih.gov.

The Fogarty International Center (FIC) is the international component in the National Institutes of Health. FIC promotes and supports scientific research internationally to minimize disparities in global health.

The Foundation for the National Institutes of Health was established by the United States Congress to support the mission in the National Institutes of Health (NIH): improving health through scientific discovery. The Foundation for NIH identifies and develops opportunities for innovative public-private partnerships involving industry, academia, and the philanthropic community. A non-profit, 501(c) (3) corporation, the Foundation raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. The Foundation’s Web site address is http://www.fnih.org.

*The supplement is made available through the support with the Fogarty International Center (FIC); Academy for Educational Development; the Bill & Melinda Gates Foundation; the Centers for Disease Control and Prevention; the Disease Control Priorities Developing Countries Project (DCPP); the Ellison Medical Foundation; the NIH; the MIM; the National Institute of Allergy and Infectious Diseases, the National Institute of Environmental Health Sciences, and the National Library of Medicine from the NIH; the United States Agency for International Development; the World Bank; and the Foundation for the National Institutes of Health through contributions from international partners including, the Burroughs Wellcome Fund; the Malaria Vaccine Initiative at the Program for Appropriate Technology in Health (PATH); the Rockefeller Foundation; the World Health Organization Roll Back Malaria Department; the Special Programme for Research and Training in Tropical Diseases, World Health Organization (TDR/WHO); Swiss Agency for Development and Cooperation; United Nations Foundation; the Wellcome Trust; and the African Regional Office, WHO.

CONTACT:
Jean Flagg-Newton, Ph.D
301-496-2075

4.2 (5 votes)

Healthcare Prof:

4.67 (6 votes)

One in five Americans have allergic rhinitis, a number that is steadily rising, but the exact reasons for this increase are unknown. A new lipid-based nasal ointment is found effective at reducing symptoms of allergic rhinitis in German patients.

Allergic rhinitis is characterized by an inflammatory response that occurs mainly in the mucous membranes of susceptible men and women after contact with set off allergens. The results are symptoms such as sneezing, itching with the nose, throat, eyes and ears, excess secretion of tears, nasal congestion and discharge, and swelling in the eyes.

Allergic rhinitis can be seasonal – responding to grain or grass pollen – or perennial, caused by publicity and contact to nonseasonal allergens found, for example, in animals and house dust. Perennial allergic rhinitis produces symptoms similar to those of seasonal allergic rhinitis, but nasal congestion is the chief complaint and conjunctivitis, or swelling in the eyes, is less common.

Antihistamines and corticosteroids are frequently used to relieve the symptoms of allergic rhinitis. These medications are associated with a low rate of side effects. Some believe that chemically and physiologically inert nasal ointments, such as the one investigated in the present study, are interesting options for adjuvant treatment of allergic rhinitis for symptom relief.

German researchers set out to assess the efficacy of a high-viscosity, lipid-based nasal ointment within the treatment of allergic rhinitis based on the observed change within the overall symptom picture. The authors of “Lipid-based Nasal Ointment for Allergic Rhinitis,” are Urban Wilhelm Geisthoff MD, Marianne Rupp-Classen MD, and Peter-Karl Plinkert MD, from your ENT Department of the University of the Saarland, Homburg/Saar; and Andreas Blum MD, at the ENT Department of the University Hospital Mannheim, Mannheim, all in Germany. Their findings are being presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO EXPO, being held September 19-22, 2004, at the Jacob K. Javits Convention Center, New York City, NY.

Methodology: This prospective, randomized, open, parallel-group comparison of 33 treated and untreated allergic rhinitis patients occurred at two centers in Germany. The study was conducted in two phases: first, a seven day preliminary assessment phase which included screening to determine patient inclusion; the second and main phase of the study consisted of 14 days of therapy at one in the two study centers (Mannheim or Homburg) after random assignment of a patient to the remedy or control group. The study was conducted from March 2002 to July 2002. Only those sufferers with sufficiently severe symptoms of sneezing, nasal itching, rhinorrhea, and nasal congestion were included.

The therapy group (of 17 individuals) was given an adequate supply in the investigational product containing a significant percentage of long-chain hydrocarbons. Those within the control groups (16 individuals) did not receive any investigational product. Using a finger or a cotton swab, each patient within the therapy groups applied a roughly one cm long strip from the investigational product to each nostril and evenly spread the ointment within the anterior portion with the nose. The ointment was applied every three to five hours except while the patient was sleeping, and could be applied more frequently if necessary.

Each patient was requested to keep separate diaries for the preliminary assessment phase and the actual treatment period using the same rules for logging entries during both investigational periods.

Apart from logging the individual symptom scores, each patient was also requested to make a record of all concomitant medications, including their type, dose, and route of administration, duration of therapy (beginning and end), and any prior treatments while in the patient diaries. The patient’s general state of health before and after completion from the study was also recorded within the patient diaries. On completion of therapy, each patient received a final examination during which the primary and secondary efficacy variables were again assessed.

The primary efficacy variable was the change in allergy symptoms, as defined by each patient’s mean relative total symptom score (TSS), which was obtained by dividing the difference between the Week 3 and Week 1 scores by the Week one score and multiplying the result by 100: Relative TSS = (TSS Week 3 – TSS Week one) / TSS Week 1 x 100.

Results: When questioned about their personal allergy history, 18 patients reported seasonal symptoms of allergic rhinitis, 12 mixed seasonal/perennial symptoms, and three perennial symptoms. The most frequent causative allergens, in order of prevalence, were grass/cereal, tree, weed and animal allergens including feathers, followed by mite allergens.

A significant reduction within the total symptom score (TSS), which was based on the 4 parameters sneezing, nasal itching, rhinorrhea, and nasal congestion was found, indicating that the lipid-based nasal ointment effectively reduced allergy symptoms.

Conclusions: The investigational product used inside the present study can be a mixture of high-purity, long-chain hydrocarbons in a high-viscosity mineral oil base. Long-chain mineral hydrocarbons are a subject of controversy in rhinology. Concerns have been expressed regarding the possible presence of postoperative paraffin granulomas following sinus surgery; additionally, there have been case reports of lipoid pneumonia in association with long-term, night-time intranasal application of a mineral oil-based nasal ointment. The latter risk was considered but deemed minimal due to the significantly lower spreading tendency while in the mucosa of our product owing to its composition characteristics.

With these reservations, the scientists determine that the lipid-based nasal ointment led to a significant reduction of allergic rhinitis symptoms in individuals in the treatment group, while the symptoms from the untreated controls remain unchanged. The trigger with the ointment’s effectiveness has yet to be identified.

Note: The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) represents the nation’s 11,000 otolaryngologist-head and neck surgeons. These specialists diagnose and treat disorders from the ear, nose, and throat and related structures with the head and neck. Learn more about the specialty and otolaryngic disorders at the AAO-HNS Internet web site, http://www.entnet.org.

American Academy of Otolaryngology Head and Neck Surgery (AAOHNS)
One Prince St.
Alexandria, VA 22314
United States
Phone 703-519-1563
Fax 703-519-1587
http://www.entnet.org/ent-press/index.cfm

1 (one votes)

Healthcare Prof:

1 (1 votes)

Surveys show about 20% of all adults believe they have food allergies. When a full evaluation and diagnosis has been performed, however, only 1 to 2% of people suffer from allergies. Because their immune systems are not yet fully developed, young children are likely to be more affected than adults.

What is food allergy?

A food allergy is an adverse reaction to a food or food component that involves the body’s immune system. Other adverse reactions to foods involve the body’s metabolism but not the immune system. These are known as food intolerance and can include reactions to food poisoning and enzyme deficiencies, which prevent proper digestion of certain food components such as lactose (milk sugar).

A true allergic reaction involves 3 primary components: Contact together with the food allergen (a reaction provoking substance, usually a protein) Increased Immunogloblin E (IgE – an antibody within the immune system that reacts to allergens) Mast cells (tissue cells) and basophils (blood cells) which when in contact with IgE antibodies release histamine or other substances causing allergic symptoms

When the body’s immune system recognises an allergen in a food, it produces antibodies to block this foreign invasion. At the same time, the body exhibits physical symptoms such as swelling with the lips, stomach cramps, vomiting and diarrhoea, hives, rashes or eczema, a running nose and breathing problems. A more serious but rare reaction is anaphylactic shock which is life threatening and requires immediate medical attention.

Allergic reactions to food are rare but may be caused by just about any food. ILSI (the International Life Sciences Institute) has categorised a list from a CODEX proposal of recognised food allergens: ‘Critical’ allergen: peanut ‘Major’ allergens: cereals containing gluten (oats, wheat, barley, rye spelt), shellfish (excluding molluscs), eggs, fish, soya, milk protein, tree nuts (almonds, hazelnuts, pistachios, pecan nuts, pine kernels, brazil nuts, cashew nuts, macadamia nuts) and sesame seeds. ‘Minor’ allergens: buckwheat, celery, fruits with stones (apricots, cherries, peaches and plums)

What to do when food allergy is suspected?

If an allergy to a food is suspected, it is best to avoid eating that food until a doctor is consulted to establish the causes, as factors such as one’s medical condition may also produce similar symptoms. If however, the symptoms are associated with a food allergy, evaluation by an allergist is essential. The only reliable diagnosis of a food allergy is actually a combination of skin tests (application in the suspect food to the skin) and double blind oral challenges (eating food or a placebo within the form of a capsule while both the patient and the doctor are unaware of either capsule’s contents).

Living with a food allergy

Presently, no adequate therapy exists to cure food allergies permanently. Once diagnosed, the only effective therapy is the so-called ‘avoidance’ diet -removing the food in question from a person’s diet. We ought to be aware that the removal of foods, especially staple foods, may require medical advice because of potential dietary imbalances, particularly in children.

http://www.eufic.org

one (one votes)

Healthcare Prof:

Scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part with the National Institutes of Health, have discovered that people with persistent sinus irritation have an exaggerated immune response to common airborne fungi. The results of their study appear online today within the Journal of Allergy and Clinical Immunology. “This study is the first to show a possible immunologic basis for persistent sinusitis, an important starting point to better fully grasp the etiology in the illness,” says Marshall Plaut, M.D., chief of NIAID’s allergic mechanisms section. Despite the enormous health impact of persistent sinusitis–nearly 30 million people were diagnosed with sinusitis in 2002, according to U.S. Centers for Disease Control and Prevention, and direct costs of the illness exceed $5.6 billion per year–the condition is very poorly understood, he states.

The scientists, led by Hirohito Kita, M.D., of the Mayo Clinic in Rochester, MN, compared blood samples taken from 18 people diagnosed with chronic sinusitis with blood samples from 15 healthy volunteers. Nasal secretions through the two groups were also examined for the presence of fungal proteins and inflammation-causing immune system molecules.

Airborne microscopic fungi spores abound indoors and out. People may inhale a million or more fungal spores each day, notes Dr. Kita. The mere presence of such fungi while in the airways, however, is not enough to trigger sinusitis because these spores can be found while in the upper respiratory tracts of both sinusitis sufferers and non-sufferers. Indeed, in this study, levels of fungal proteins in nasal secretions were similar in both groups.

The Mayo Clinic scientists looked for evidence that people with sinusitis respond abnormally to these harmless fungi. The investigators exposed immune cells derived from your blood samples to extracts of 4 common airborne fungi: Alternaria, Aspergillus, Penicillium and Cladosporium. The cells of chronic sinusitis sufferers released significant amounts of 3 immune-modulating chemicals, called cytokines, specifically interferon-gamma, interleukin-5 (IL-5) and IL-13. In contrast, cells from healthy volunteers released very little interferon-gamma and no IL-5 or IL-13. The most dramatic responses occurred after publicity to Alternaria.

Importantly, says Dr. Kita, the released cytokines represent both major classes of cytokines–interferon-gamma is inside the Th1 group and IL-5 and IL-13 are in the Th2 class. This is notable because scientists have thought that allergic reactions involve only Th2 cytokines, Dr. Kita explains. (While persistent sinusitis is not considered to be an allergic disease, people using the condition also often have asthma and allergic rhinitis, giving scientists cause to suspect a link.) The current findings add to an evolving understanding of allergic diseases that suggests symptoms may stem from a combination of Th1 and Th2 cytokines.

The combined effect of excess Th2 and Th1 cytokines released while in the presence of fungi may explain a number of chronic sinusitis symptoms, including persistent inflammation of sinus and nasal mucous passages, say the scientists.

Previously, Mayo clinic scientists used intranasal antifungal agents to successfully treat individuals with chronic sinusitis. While those studies generated controversy, in part because other researchers were unable to replicate the findings, Dr. Kita says modern report supports the rationale of treating chronic sinusitis with antifungals. Medical trials to further test antifungal treatment for persistent sinusitis are being planned, adds Dr. Kita.

###

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

Reference: S-H Shin et al. Chronic rhinosinusitis: An enhanced immune response to ubiquitous airborne fungi. The Journal of Allergy and Medical Immunology. Published online Oct. 8, 2004. doi: 10.1016/j.jaci.2004.06.012.

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

Contact: Anne A. Oplinger
aoplinger@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases

four.33 (three votes)

Healthcare Prof:

A group led by Mayo Clinic researchers has identified that over-reactive immune responses to airborne fungi could trigger the stuffy noses and airway inflammation among sufferers of chronic rhinosinusitis. These findings could 1 day result in a brand new, longer-lasting treatment.

“It’s time for you to identify there is a higher sensitivity to airborne fungi in certain patients, and consequently we have to get rid of or decrease the fungal exposure,” says lead investigator Hirohito Kita, M.D.

In today’s electronic version of the Journal of Allergy and Clinical Immunology http://www2.us.elsevierhealth.com/scripts/om.dll/serve?action=searchDB&searchDBfor=home&id=ai , the Mayo Clinic scientists and a colleague from the University of Utah conclude that certain species of airborne fungus produce spores and by-products, that when inhaled, prompt irregular and damaging immune responses. The responses, in turn, produce the congestion and inflammation. Chronic rhinosinusitis costs society about $5.6 billion a year. And that doesn’t include an estimated $70 million in annual lost work days, as well like a diminished quality of life.

Implications of Research

“The fungi we’re talking about are very common,” Dr. Kita. “They are airborne fungi found anywhere inside the United States. Now that we know the role from the fungi, we can work toward reducing the potential role with the fungi through such treatments as nasal irrigations (flushing with water) that clear the fungi, or prescription of antifungal medicines taken by mouth.”

Preliminary results show that the irrigation therapy relieves symptoms. Larger, multicenter studies are needed before this therapy can move into general use. But the results are encouraging because they support the idea that reducing fungal publicity in sensitive individuals could offer a brand new remedy option to victims worldwide.

Background

Chronic rhinosinusitis is 1 with the most common persistent illnesses while in the United States. Its symptoms include persistent stuffy nose, thick mucus production and loss of smell. Though chronic rhinosinusitis causes significant discomfort and health problems, it is not well understood. Viruses, bacteria and allergic reactions all have been researched and debated as potential mechanisms driving the responses. The immune system mounts different kinds of responses for different invaders — a bacterium gets attacked by a different cell or system than an allergy-prompting particle, for example. That’s why it’s critical to determine the key mechanisms while in the immune response to persistent rhinosinusitis, allowing scientists to design treatments to relieve the distressing symptoms.

The Mayo Clinic work is the first to provide data for the role of airborne fungi in persistent rhinosinusitis and to show that several immune system branches appear to collaborate in response to the fungi — resulting in an abnormally enhanced response that causes troublesome inflammation and congestion. The research team’s data show that specific cells in 90 percent of chronic rhinosinusitis sufferers produce an enhanced immune-system response to 1 fungus in particular, Alternaria. Another kind of common fungus, Cladosporium, also provoked an abnormally enhanced immune response.

Mayo Clinic scientists previously used antifungal therapies to treat patients with chronic sinusitis, which marked a new medical approach. These new findings serve to further support this perspective and will prompt additional research.

The Investigation

Researchers tested blood from 18 individuals with persistent rhinosinusitis and 15 healthy persons to evaluate how specific immune system cells responded to common airborne fungi. The immune systems of those with chronic rhinosinusitis reacted more robustly than those of healthy folks. In fact, when exposed to Alternaria, 1 branch of the immune system’s response was five times greater in the chronic rhinosinusitis individuals than within the healthy volunteers.

The research team investigated the body’s responses to this fungal exposure by measuring components within the two branches in the adaptive immune system. The adaptive immune system takes several days to mount a response to foreign invaders. The two branches of the adaptive immune system are: one) a cell-directed branch that involves special cells known as T lymphocytes and 2) the humoral branch, which works primarily through cells known as B lymphocytes.

###

Research Group Members and Support

In addition to Dr. Kita, the Mayo Clinic research group includes Seung-Heon Shin, M.D.; Jens Ponikau, M.D.; David Sherris, M.D.; David Congdon, M.D.; Evangelo Frigas, M.D.; Henry Homburger, M.D.; and Mark Swanson. The University of Utah collaborator was Gerald Gleich, M.D. Their work was supported by a grant from your National Institute for Allergy and Infectious Diseases and by the Mayo Foundation.

To obtain the latest news releases from Mayo Clinic, go to http://www.mayoclinic.org/news. MayoClinic.com (http://www.mayoclinic.com) is available as a resource for your health stories. For more information about research at Mayo Clinic, go to http://www.mayo.edu.

Contact: Bob Nellis
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
http://www.mayo.edu

5 (1 votes)

Healthcare Prof:

VaxGen, Inc (VXGN.PK) announced today that the U.S. government has awarded the company an $877.5 million contract to supply 75 million doses of anthrax vaccine for civilian defense.

The contract, the initial of its kind under the Project BioShield Act of 2004, is intended to supply enough item to vaccinate 25 million Americans in a multiple-dose regimen against inhalation anthrax, the most deadly form of the disease and the one most likely to be used as a bioterrorist weapon.

“We are honored to play such an important role in our nation’s defense,” said Lance K. Gordon, Ph.D., VaxGen’s President and Chief Executive Officer. “The spirit of cooperation that we enjoyed with various branches of government is a tribute towards the commitment that we all feel toward strengthening America’s biodefense. I would particularly like to thank the Department of Health and Human Services, and, much more specifically, the National Institute of Allergy and Infectious Diseases, as well as the Administration and members of Congress from both parties for their leadership in calling for improved biodefense measures.”

The contract calls on VaxGen to present 25 million doses of its recombinant Protective Antigen anthrax vaccine towards the Strategic National Stockpile (SNS) within two years of the award and a total of 75 million doses within three years. The SNS is a national repository of medical goods maintained by the Centers for Disease Control and Prevention. For the remainder of the 5-year contract, VaxGen is going to be maintaining active manufacturing operations and providing stockpile-related services.

VaxGen expects to recognize revenue from the supply contract upon acceptance of the vaccine by the U.S. government and delivery to the SNS. VaxGen will be operating closely with the government to deliver the vaccine beginning in early 2006.

Under the authority of the Project BioShield Act of 2004, the U.S. government intends to begin taking delivery of the vaccine prior to it is licensed for use by the Food and Drug Administration (FDA). Vaccine bought prior to FDA approval could be used in an emergency if authorized by the Secretary of Health and Human Services.

Under the terms of the contract, VaxGen is required to continue developing the vaccine with the goal of receiving FDA approvals for use of the vaccine both before and after exposure to anthrax. The vaccine has already received Fast-Track designation, meaning that the FDA will take actions that are appropriate to expedite the development and review of a license application for the vaccine, when and if it is submitted towards the FDA.

The majority of the supply contract’s value relates to a discounted payment at a fixed base price for delivery of the vaccine in advance of licensure. Payment is contingent upon delivery of useable item, defined as having the regulatory data permitting emergency use under Investigational New Drug status and manufactured under licensable conditions. Development costs required to license the vaccine, over and above those covered by VaxGen’s two previous contracts with the National Institute of Allergy and Infectious Diseases, are getting borne by VaxGen. These remaining development costs will likely be recovered through sale of the vaccine under this contract.

Supplemental milestone payments towards the fixed base price per dose are payable after the completion of two regulatory and one product development milestones. The two regulatory milestones are FDA licensure of the vaccine for use before and after exposure to anthrax. The item development milestone requires demonstration of a shelf-life of the vaccine commensurate with industry standards.

Above the base amount of $877.5 million, the contract also includes task orders, valued at up to $69 million, which can be awarded at the government’s discretion. These tasks, which would be funded under cost-plus fixed-fee arrangements, include testing the vaccine in children and the elderly, maintaining manufacturing operations for the vaccine and post-marketing studies.

The contract has been funded in whole with Federal funding under Project BioShield, Contract No. HHSN 261-05-0001C.

VaxGen plans to manufacture the bulk protein antigen used in the vaccine, rPA102, in its California manufacturing facility. The vaccine will likely be filled in syringes for rapid deployment.

About rPA102

VaxGen’s rPA102 vaccine is composed of a purified protein called recombinant Protective Antigen (rPA) and an aluminum salt routinely used in many vaccines. This design produces a vaccine that is expected to be well characterized and consistent across manufacturing runs. Recombinant Protective Antigen induces antibodies shown to neutralize anthrax toxins. rPA102 cannot cause anthrax infection.

The National Institute of Allergy and Infectious Diseases began funding the advanced development of VaxGen’s rPA102 vaccine in September 2002 to address the urgent need for a modern recombinant anthrax vaccine that has a strong safety profile and which provides protective immunity with no far more than three doses.

The only currently licensed anthrax vaccine in the United States requires the administration of six doses and is a partially purified product derived from filtrates of anthrax bacillus cultures.

rPA102 is based on function conducted at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). VaxGen has exclusive, worldwide rights to develop and commercialize a recombinant anthrax vaccine candidate based on patented technology developed by USAMRIID. The agreement is subject to certain rights retained by the government.

Conference Call Information

VaxGen will hold a conference call tomorrow, Friday, Nov. five at Noon ET to review this press release. The following phone numbers and website will present access to the call:

Live Call Domestic: 866-546-6145
International: 800-3214-9100
No passcode required.

Replay:
Domestic: 888-818-4095
International: 416-695-6332
Passcode: 8712

Investors may access an audio web cast of the presentation by clicking on “VaxGen Anthrax Vaccine Conference Call” under “Webcasts” in the Investor Relations section of VaxGen’s web site at www.vaxgen.com/invest.

About VaxGen

VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic merchandise for the prevention and treatment of human infectious disease. Based in Brisbane, Calif., the company is developing preventive vaccines against anthrax and smallpox. For much more details, please visit the company’s web site at: http://www.vaxgen.com

Note: This press release contains “forward-looking statements” within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and the Company’s ability to meet the requirements of its government-funded anthrax vaccine contracts, including the completion of clinical and non-clinical trials, manufacture and delivery of the vaccine towards the SNS; statements regarding the timing of revenue recognition and payments due upon achievement of regulatory and product development goals; and statements regarding FDA licensure of the item, including the scope of such licensure and the Company’s plans to seek licensure. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 1 of the company’s Annual Report on Form 10-K filed by VaxGen on March 30, 2004, under the heading “Additional Business Risks” for a far more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new info, events, or circumstances after the date of this release except as required by law.

Contacts:

Media
Kesinee Angkustsiri Yip
Associate Director. Corporate Communications
(650) 624-2304

Investors
Lance Ignon
Vice President, Corporate Affairs
(650) 624-1041

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