Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from panax or acanthopanax
Reexamination Certificate
2000-12-11
2003-10-14
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from panax or acanthopanax
C424S725000, C424S729000, C424S737000, C424S641000, C424S702000, C424S630000, C424S769000, C514S532000, C514S533000, C514S458000, C514S706000, C514S885000
Reexamination Certificate
active
06632459
ABSTRACT:
The invention relates to a preparation for stimulating the immune system. The invention further relates to a method of treating and/or preventing a medical condition by administration of said preparation to a human or an animal and to a method to manufacture a product for use in prophylaxis and/or treatment of a medical condition.
The immune system in animals, including humans, plays an important role in prevention and treatment of many disorders/diseases, such as infections by foreign bodies such as bacteria, viruses, parasites, toxins or proteins, but also in the prevention and treatment of various forms of cancer. Viruses or bacteria may for example cause infections in the respiratory tract, or cause systemic infections (e.g. herpes virus). Infections may also be associated with other diseases such as an infection by a cytomegalo-virus (CMV) in an AIDS patient or an infection by pneumococcen sp in a cancer patient. Such an infection is also referred to as a secondary infection.
In clinical practice, large groups of hospital patients or other persons suffering from an underdeveloped (e.g. neonates) or compromised (e.g. cancer or transplantation patients treated with chemotherapeutics or part of the elderly population) immune function, suffer at one point in time from (primary or secondary) infections, which may increase the period of hospital stay or the duration of an illness in general. An underdeveloped or compromised immune function of patients may require aggressive treatment with antibiotics, which even can lead to life-threatening situations.
In daily life, also “healthy” persons are frequently infected by a foreign entity such as a virus and/or a bacterium, leading to symptoms such as bad wound healing, pain, fever or general malaise. Commonly known examples thereof are various infections of the respiratory tract, including the throat, and such infections frequently occur in particular after stress (e.g. due to bad weather, heavy exercise or emotional stress).
The functioning of the immune system is inter alia related to various chemical substances that are produced in vivo or obtained by nutrition. Administration of such substances in order to support the immune function can help prevention and/or treatment of many diseases. In addition various substances such as antioxidants, are known to play a beneficial role in the prevention and treatment of diseases. Antioxidants may prevent damage of healthy cells by radicals, formed by the immune system, that are directed against infecting moieties (infectants).
The presence of chlorogenic acid in an antioxidant composition is reported in U.S. Pat. No. 5,788,971. In this publication, sunflower seed extract containing chlorogenic acid and green tea leaf extract containing EGCG is said to be able to scavenge free radicals, which may be useful in the treatment of inflammatory disorders.
European patent application 0/906/761 also mentions chlorogenic as a possible antioxidant.
In JP 60243016 an anti-influenza tablet is described containing 3,5-dicaffeoylqluinic acid obtained by subjecting a methanol extract of a
Helianthus annus
seed to counter-current distribution.
In WO 99/34812 a composition comprising baicalin, chlorogenic acid and forsythiaside is reported to have antiviral, antibacterial or immuno-modulating properties. According to this publication said composition is capable of increasing the natural killer cell (NK cell) activity and the interferon-&agr; production of peripheral blood cell lymphocytes in vitro. It remains unclear from this publication what the contribution of chlorogenic acid is in a composition mentioned in this publication.
With respect to prevention of diseases, there is a limited value to administering substances which may give protection to the subject in a general way. It is however also possible to stimulate the immune system more specifically, such as by vaccination of an animal and human to give protection against a particular disease. Vaccination aims to present an innocuous yet antigenic form of an infectious organism or its toxin(s), for establishing protective immunity. So called T-lymphocytes play an important role in this process. By vaccination the immune system can very specifically be stimulated to become active against a particular antigen. Large vaccination programs, are currently applied, both to animals and to humans, against a wide variety of diseases. This vaccination may cause discomfort to a subject that is vaccinated, and sometimes has limited success.
The present invention seeks to provide a preparation to stimulate or to enhance the immune system of animals or humans to be more effective. Surprisingly it has been found that a preparation comprising one or more agents that stimulate T-lymphocytes proliferation in vivo have the desired effect.
Accordingly the invention relates to a preparation for stimulating or enhancing an immune system comprising one or more agents that stimulate T-lymphocytes in vivo.
Highly suitable agents that stimulate T-lymphocytes in vivo have been found to be chlorogenic acid (1-caffeoylquinic acid) or a functional analog thereof. Preferred examples of chlorogenic acid and functional analogs thereof may be represented by formula 1:
wherein “a” represents either a single bond or a double bond and R
1
is only present in case “a” represents a single bond, and wherein at least one of the functional groups R1-R4, preferably at least R4, represents a functional group represented by formula 2 (further referred to as subst. II)
and the remaining of said functional groups R1-R4 are independently chosen from the group formed by —OH, and other substituents—like caffeic acid moiety analogs—that are abundant in a material of a vegetable nature and can be split off by the intestinal flora. It is to be noted that the compound of formula 1 has the 1&agr;, 3&agr;, 4&agr;, 5&bgr;-hydroxy configuration.
Preferred functional analogs of chlorogenic acid in a preparation according to the invention are 4-caffeoylquinic acid, neochlorogenic acid (3-caffeoylquinic acid), dicaffeoyl quinic acids wherein the 1 and 5 positions are substituted (1,5-dicaffeoylquinic acid), isochlorogenic acids (i.e. dicaffeoyl quinic acids substituted on 3 and 4 positions, 3 and 5 positions or 3, 4 and 5 position (3,4,5 tricaffeoyl quinic acid)), kryptochlorogenic acid (4-O-caffeoylquinic acid, cynarin (1,3-O-caffeoylquinic acid), 1,3,4,5-O-tetracaffeoylquinic acid and caffeoylshikimic acids, in particular 5-O-caffeoylshikimic acid. With reference to formula 1, these analogs have the following chemical structures:
Compound
R
1
R
2
R
3
R
4
(−)-quinic acid
OH
OH
OH
OH
1-O-caffeoyl quinic acid
subst. II
OH
OH
OH
chlorogenic acid
OH
OH
OH
subst. II
(5-O-caffeoylquinic acid
kryptochlorogenic acid
OH
OH
subst. II
OH
neochlorogenic acid
OH
subst. II
OH
OH
cynarin
subst. II
subst. II
OH
OH
(1,3-O-dicaffeoylquinic acid)
1,5-O-dicaffeoylquinic acid
subst. II
OH
OH
subst. II
3,4-O-dicaffeoylquinic acid
OH
subst. II
OH
OH
3,5-O-dicaffeoylquinic acid
OH
subst. II
OH
subst. II
4,5-O-dicaffeoylquinic acid
OH
OH
subst. II
subst. II
1,2,3,4-O-tetracaffeoylquinic acid
subst. II
subst. II
subst. II
subst. II
Chlorogenic acid and functional analogs thereof will be referred to herein as CA-compounds.
A CA-compound in a preparation according to the invention may be of synthetic origin, or of natural origin Chlorogenic acid and derivatives thereof can be synthesized by applying one of the methods known in the art, such as the method described by Panizzi et al. (Gazz.Chim.Ital, 86, 913, (1956)). Alternative sources for chlorogenic acid and its derivatives are inter alia
Vaccinium myrtillus
extracts, potato extracts (pressing juice) and sunflower extracts.
The preparation may comprise plant material in raw form. This may be advantageous, in particular to lower the cost-price of preparation. A CA-compound in the preparation is preferably of natural origin, e.g. as an extract of one or more plants. The extracts (or raw material) can for example be taken from plants like Echinacea sp., green coffee bean, green
Graus Yvo Maria Franciscus
Hageman Robert Johan Joseph
Osterhaus Albertus Dominicus Marcellinus Erasmus
Smit Hobbe Friso
Banner & Witcoff , Ltd.
Nutricia N.V.
Tate Christopher R.
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