Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – X-ray contrast imaging agent
Reexamination Certificate
2001-03-13
2004-08-10
Chan, Christina (Department: 1644)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
X-ray contrast imaging agent
C424S184100, C424S275100, C424S539000, C424S810000
Reexamination Certificate
active
06773695
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
This invention relates to the field of allergy vaccines and treatments. More particularly, the invention contemplates a method of delivery of allergens.
BACKGROUND
An allergy is the result of a powerful immune system reaction against a substance that should normally be inoffensive to the host. A recent survey by the American College of Allergy, Asthma and Immunology (ACAAI) reveals that approximately 38% of the US population suffers from allergies (
Immunotherapy Weekly
, Nov. 29, 1999). If the ACAAI estimate is correct, at least 85 million Americans have allergies.
Allergies are caused by an imbalance or hypersensitivity of the immune system, leading to a misdirected immune response. An allergic response occurs when the immune system reacts inappropriately to highly specific agents that in most people do not cause an immune response, such as tree and grass pollens, cockroaches, dust mites, animal dander, latex, or honeybee, wasp and fire ant venoms. Other common allergens include foods such as peanuts, tree nuts, milk, fish, shellfish, eggs, soy, wheat, honey, cantaloupe, strawberries and tropical fruits, drugs such as penicillin, anesthetics, serum, some viruses, bacteria and protozoa, and mold. Delayed type hypersensitivity reactions may occur in response to urushiol, an oil found in poison ivy, poison oak and sumac, resulting in a severe itchy rash and formation of oozing blisters.
Allergens are discussed inter alia in the following articles which are incorporated herein by reference: Blaauw P J, Smithuis O L, Elbers A R. The value of an in-hospital insect sting challenge as a criterion for application or omission of venom immunotherapy.
J Allergy Clin Immunol
. 1996;98:39-47; Bousquet, J, Lockey, R F, Malling, H-J. Allergen immunotherapy: therapeutic vaccines for allergic diseases [WHO Position Paper].
World Health Organization, Allergy
. 1998; 53(suppl):12-16; Lack G, Nelson H S, Amran D, et al. Rush immunotherapy results in allergen-specific alterations in lymphocyte function and interferon-&ggr; production in CD4+ T cells.
J Allergy Clin Immunol
. 1997;99:530-538; Müller U. Diagnosis and treatment of insect sting sensitivity.
J Asthma Res
. 1966;3:331-333; Weber, R W. Immunotherapy with allergens.
JAMA
. 1997;278:1881-1887.
The first exposure to an effective allergen causes only a mild immune response that sensitizes the immune system to the substance. However, subsequent exposures to the allergen result in allergic symptoms, typically in a dose dependent manner (ie, the allergen must reach a certain threshold), and may cause an increasingly severe response with repeated exposures. Allergic symptoms include itching and swelling of affected tissues, rashes, muscle spasms and other more severe symptoms. See Table 1 below for the Müller classification of allergic reactions. The type of symptom depends on the specific allergen, the part of the body where exposure occurs, and the degree of sensitization of the individual. Allergens that are inhaled often cause nasal congestion, itchy nose and throat, and mucus production. In highly allergic individuals or with higher doses of allergen, coughing, wheezing, or similar symptoms occur. In contrast, ingested allergens cause itching of the throat, vomiting, stomach cramps, diarrhea, and skin rashes or shock, in cases of strong sensitivity. Eczema is also associated with allergies; a decrease in allergies results in an improvement of eczema.
TABLE 1
Müller Classification of Allergic Reactions
Large
Swelling at site of sting with diameter >10 cm,
local reactions
lasting >24 h
Systemic reactions
Grade I:
Generalized urticaria, itching, malaise, anxiety
Grade II:
Any of the above, plus 2 more of the following:
angioedema (also grade II if occurs alone), constric-
tion in chest, nausea, vomiting, diarrhea, abdominal
pain, dizziness
Grade III:
Any of the above, plus 2 or more of the following:
dyspnea, wheezing, stridor (any of these alone are
grade III), dysphagia, dysarthria, hoarseness, weak-
ness, confusion
Grade IV:
Any of the above, plus 2 or more of the following:
fall in blood pressure, collapse, loss of conscious-
ness, incontinence (urine, stool), cyanosis
The largest numbers of allergy sufferers, about 45 million Americans, are those who are allergic to pollen and are afflicted with airway diseases such as allergic rhinitis, hay fever and asthma. People with seasonal pollen allergies often develop cross-sensitivity to other allergens that are present all year, such as dust mites. People with chronic respiratory allergies often develop asthma, which is the consequence of long-term activation of the allergic/inflammatory response in the respiratory system. The symptoms of asthma include coughing, wheezing, and shortness of breath due to a narrowing of the bronchial passages, excess mucus production and inflammation. Asthma can be disabling and sometimes fatal.
Cockroach allergy is an allergy to the excrement of cockroaches, and is a trigger of asthmatic attacks. Dust mite allergy is an allergy to the excrement of a microscopic organism living in dust found in all dwellings and workplaces, and in virtually all bedding. Dust mites are perhaps the most common cause of perennial allergic rhinitis, producing symptoms similar to pollen allergy and asthma. About half of all allergy sufferers are allergic to dust mites.
Over 10 million Americans are allergic to animals. Household pets are the most common source of such reactions. Many people think the fur of cats and dogs provokes pet allergies. However, the major allergens are proteins secreted by oil glands in the animal's skin and shed in dander; and in the saliva, which sticks to the fur when the animal licks itself. When the saliva carrying the proteins dries, the proteins float into the air and are inhaled by people. Some rodents, such as guinea pigs and gerbils, have become increasingly popular as household pets. They, too, can cause allergic reactions in some people, as can mice and rats.
Between 6 and 7 million Americans are affected by food allergies. Food allergies are different from food intolerances, since food intolerances do not involve the immune system. Up to 3 million Americans are highly allergic to peanuts and tree nuts. Eight foods account for 90% of food allergies: milk, fish, peanuts, tree nuts, eggs, soy, wheat, and shellfish. In these cases, systemic reactions may be severe, such as onset of allergic shock. To avoid serious consequences including death, people allergic to foods carry strong antihistamines. Even so, treatment or preventative measures for food allergies are often only marginally effective. The primary therapy is simply total avoidance of the specific allergen. Conventional subcutaneous allergy shots are ineffective against food allergies.
Approximately 5 million people in the Unites States are allergic to bee or wasp stings, in many cases with potentially life threatening symptoms. Three out of 5 of allergic people stung will experience a severe reaction if stung again.
In developed countries, the frequency of allergic reactions has increased dramatically in recent years, to the extent that about 20% or more of the population of the United States has allergies to some common substance. Overall, allergic diseases are the 6th leading cause of chronic disease in the United States. Heredity, environmental conditions, type and number of exposures, and various physiological factors such as stress, fatigue and emotional upset can increase the sensitivity of the immune system and predispose a person to allergies.
The reason for the increase in the number of allergy sufferers is currently under intense scientific debate. There are several possible explanations on which most scientists can agree. Air pollution with nitric oxides (NO
x
) may play a role in the increasing frequency of allergic airway disease. Not only do nitric oxides increase the production of allergenic proteins in pollen, but they also directly damage sensitive cells lining the airway of the throat and lungs. This damage ha
Kündig Thomas M.
McCormack Stephen J.
Chan Christina
Huynh Phuong
MannKind Corporation
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