Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1999-09-30
2001-05-22
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
Reexamination Certificate
active
06235287
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to certain diterpenes for use as medicaments and to extracts or concentrates of the plant
Curcuma amada
containing them. Further, the invention relates to pharmaceutical compositions, possibly in the form of dietary supplements or cosmetics, containing at least one of the diterpenes or an extract or concentrate of
Curcuma amada,
as well as to the use of the diterpenes or the extracts or concentrates of
Curcuma amada
for the preparation of medicaments for immunomodulation or the alleviation of pain, and specifically for the suppression of hypersensitivity or inflammatory reactions and the treatment or prevention of diseases associated with hypersensitivity reactions. The invention also relates to a method of preparing an extract of
Curcuma amada.
BACKGROUND OF THE INVENTION
Curcuma amada
Roxb. (family Zingiberaceae), also commonly known as Mango Ginger, is cultivated and grows wild throughout India. The herb is rhizomatous with a leafy tuft, 60-90 cm high with white or pale yellow flowers in spikes in the centre of the tuft of leaves.
A number of chemicals have been identified as major components of
Curcuma amada.
Among these are ocimene, dihydro-ocimene, &agr;-pinene, &agr;-curcumene, &bgr;-curcumene, linalool, cuminyl alcohol, keto-alcohol, camphor, turmerone, linalyl acetate, safrole, curcumin, myristic acid, car-3-ene, myrcene, 1,8-cineol, limonene, perillene, etc.
Hypersensitivity is defined as a state of altered reactivity in which the body reacts with an exaggerated immune response to a substance (antigen). Hypersensitivity may be caused by exogenous or endogenous antigens.
Hypersensitivity reactions underlie a large number of diseases. Amongst these allergic and autoimmune conditions are of great importance. A classification of hypersensitivity diseases is given by Parveen Kumar and Michael Clark in the textbook Clinical Medicine
1
Type I hypersensitivity reactions (IgE mediated allergic reactions) are caused by allergens (specific exogenous antigens), e.g. pollen, house dust, animal dandruff, moulds, etc. Allergic diseases in which type I reactions play a significant role include asthma, eczema (atopic dermatitis), urticaria, allergic rhinitis and anaphylaxis.
Type II hypersensitivity reactions are caused by cell surface or tissue bound antibodies (IgG and IgM) and play a significant role in the pathogenesis of myasthenia gravis, Goodpasture's syndrome and Addisonian pernicious anaemia.
Type III hypersensitivity reactions (immune complex) are caused by autoantigens or exogenous antigens, such as certain bacteria, fungi and parasites. Diseases in which type III hypersensitivity reactions play a significant role include lupus erythematosus, rheumatoid arthritis and glomerulonephritis.
Type IV hypersensitivity reactions (delayed) are caused by cell or tissue bound antigens. This type of hypersensitivity plays a significant role in a number of conditions, e.g. graft-versus-host disease, leprosy, contact dermatitis and reactions due to insect bites.
A number of drug classes are available for the treatment of hypersensitivity reactions. Some of these are systemic and some are applied topically.
The corticosteroids are among the most widely used drugs for the treatment of hypersensitivity diseases. Corticosteroids primarily exert their pharmacological action by non-selectively inhibiting the function and proliferation of different classes of immune cells. Hereby hypersensitivity reactions are suppressed. Unfortunately the corticosteroids are associated with a number of serious side effects e.g. immuno-suppression, osteoporosis and skin atrophy (when applied topically).
SUMMARY OF THE INVENTION
We have found that compounds of formula I:
wherein R
1
and R
2
are independently CH
2
OH or CHO, and extracts or concentrates of
Curcuma amada
containing at least one compound of formula I significantly suppress hypersensitivity reactions.
Compared to the corticosteroids the compounds of formula I or extracts of
Curcuma amada
containing compounds according to formula I have the advantage of not being associated with any serious side effects.
Due to their pharmacological effects compounds of formula I or extracts of
Curcuma amada
containing compounds according to formula I can be employed for the following therapeutic applications:
Immunomodulation.
Treatment or prevention of hypersensitivity diseases.
Treatment or prevention of IgE mediated allergic reactions and conditions.
Treatment or prevention of autoimmune disorders.
Alleviation of pain.
Accordingly the present invention provides a pharmaceutical composition, dietary supplement or cosmetic containing at least one compound of formula I or an extract or concentrate of
Curcuma amada
and a pharmaceutically acceptable carrier.
A “dietary supplement” is defined, according to the U.S. Food and Drug Administration in the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The DSHEA gives the following formal definition of a “dietary supplement”:
A dietary supplement:
is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these things.
is intended for ingestion in pill, capsule, tablet, or liquid form.
Similar definitions exist in other parts of the world, e.g. in Europe. Different denominations concerning “dietary supplements” or similar food products are used around the world, such as “food supplements”, “neutra-ceuticals”, “functional foods” or simply “foods”. In the present context the term “food supplement” covers any such denomination or definition.
More specifically the present invention provides the use of at least one compound of formula I or an extract or concentrate of
Curcuma amada
for preparing a medicament for immunomodulation, for the suppression of hypersensitivity reactions such as IgE mediated allergic reactions and autoimmune reactions, and for the alleviation of pain.
Thus, according to the invention at least one compound of formula I or an extract or concentrate of
Curcuma amada
can be used in a method for the treatment or prevention of a hypersensitivity disease in an individual, which comprises administering such substances or a pharmaceutical composition or dietary supplement containing it to said individual; and the invention comprises the use of at least one compound of formula I or an extract or concentrate of
Curcuma amada
for preparing a medicament for the treatment or prevention of hypersensitivity diseases.
Also, according to the invention at least one compound of formula I or an extract or concentrate of
Curcuma amada
can be used in a method for the treatment or prevention of an autoimmune disorder in an individual, which comprises administering such substances or a pharmaceutical composition or dietary supplement containing it to said individual; and the invention comprises the use of at least one compound of formula I or an extract or concentrate of
Curcuma amada
for preparing a medicament for the treatment or prevention of autoimmune disorders.
Further, according to the invention at least one compound of formula I or an extract or concentrate of
Curcuma amada
can be used in a method for the treatment or prevention of an IgE mediated allergic reaction or condition in an individual, which comprises administering such substances or a pharmaceutical composition or dietary supplement containing them to said individual; and the invention comprises the use of at least one compound of formula I or an extract or concentrate of
Curcuma amada
for preparing a medicament for the treatment or prevention of IgE mediated allergic reactions and conditions.
Also, according to the invention at least one compound of formula I or an extract or concentrate of
Curcuma amada
can be used in a method for th
Jacobsen Nina
Petersen Morten Just
Weidner Morten Sloth
Coe Susan D.
Darby & Darby
IDA Development A/S
Prats Francisco
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