Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a tree having matured height of...
Reexamination Certificate
2001-11-19
2003-11-04
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a tree having matured height of...
C424S776000, C424S777000, C514S824000
Reexamination Certificate
active
06641850
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Area of the Art
The invention relates generally to pomegranate extracts and methods of using thereof, and specifically to methods of using pomegranate extracts for causing regression in lesions due to arteriosclerosis in humans.
2. Description of the Prior Art
Throughout this application, various references are referred to within parentheses. Disclosures of these publications in their entireties are hereby incorporated by reference into this application to more fully describe the state of the art to which this invention pertains. Full bibliographic citation for these references may be found at the end of this application, preceding the claims.
Oxidative stress, a major contributor to cardiovascular diseases (1), is associated with lipid peroxidation in arterial macrophages and in lipoproteins (1-3). Oxidized low-density lipoprotein (Ox-LDL) was shown to be atherogenic (2-4), thus, interventions to inhibit LDL oxidation by dietary antioxidants (4, 5) is of major importance to attenuate atherosclerosis. It was recently shown that vitamin E supplementation to patients with carotid artery stenosis inhibited LDL accumulation in arterial macrophages (6). Protection of lipids from oxidation can be also achieved by serum paraoxonase (PON1, an HDL-associated esterase that can hydrolyze and reduce specific lipid peroxides in arterial cells and lipoproteins in coronary and carotid lesions (7-10).
The pomegranate was recently chosen as the logo for the Millennium Festival of Medicine, mainly because of its medicinal properties as described by all major religions and by folk medicine (11). Pomegranate juice (PJ) possesses impressive antioxidative properties due to its high flavonoids content, mainly the water soluble tannins and proanthocyanins (12). We have recently shown the antioxidative and antiatherogenic characteristics of PJ consumption in atherosclerotic apolipoprotein E deficient (E
o
) mice (13). In healthy humans, PJ consumption also demonstrated potent antioxidative capabilities against lipoprotein oxidation, and also increased PON1 activity and improved serum total antioxidant status (13).
A need exists, however, to study whether the above beneficial effects of PJ can be manifested in patients with atherosclerosis such as carotid artery stenosis.
SUMMARY OF THE INVENTION
The present invention is based on the unexpected discovery that pomegranate juice consumption by a patient with atherosclerosis may cause regression of the size of atherosclerotic lesions. Prior to the present invention, it has been observed that pomegranate juice consumption by E
0
mice may slow down the progression of arteriosclerosis, and reduce the expected increase in the size of atherosclerotic lesions. It is the discovery of the present invention that pomegranate juice consumption by a patient with atherosclerosis, however, not only can slow down the progression of arteriosclerosis, but also can reduce the size of atherosclerotic lesions that are already developed, and therefore cause regression of the lesion size.
Accordingly, one aspect of the present invention provides a method for treating a patient with arteriosclerosis. The method comprises the step of administering to the patient a composition comprising a therapeutically effective amount of an extract from pomegranate fruit. According to embodiments of the present invention, the arteriosclerosis may be carotid artery arteriosclerosis or coronary artery arteriosclerosis. The extract of pomegranate may be a juice extract of pomegranate, an extract from inner or outer peel of pomegranate, or the mixture thereof.
Another aspect of the present invention provides a method of treating a patient with an increased intima-media thickness of an artery. The method comprises the step of administering to the patient a composition comprising an amount of an extract from pomegranate which is therapeutically effective to reduce the intima-media thickness of the artery. According to embodiments of the present invention, the intima-media thickness of the artery is due to arteriosclerosis, such as, but not limited to, coronary artery arteriosclerosis and carotid artery stenosis, diabetes, high blood pressure, and peripheral vascular disease.
A further aspect of the present invention provides a method of decreasing the incidence of stroke and heart attack in a patient. The method comprises the step of administering to the patient a composition comprising a therapeutically effective amount of an extract from pomegranate. According to the embodiments of the present invention, the stroke or the heart attack is associated with artery arteriosclerotic diseases, including but not limited to, coronary artery arteriosclerosis and carotid artery stenosis, diabetes, high blood pressure, and peripheral vascular disease.
The invention is defined in its fullest scope in the appended claims and is described below in its preferred embodiments.
REFERENCES:
patent: 404124140 (1992-04-01), None
patent: 410298094 (1998-11-01), None
patent: WO 98/29129 (1998-07-01), None
patent: 200137848 (2001-05-01), None
International Product Alert bulletin. Dec. 15, 1997. Rubyan Persia Pomegranate Concentrate Extract. PROMT Database. Full text abstract, 1 p.*
Glozman et al. Khim.-Farm. Zh. 1989. Vol. 23, No. 9, pp. 111-1115—see full English translation (10 pp.).*
Kathy K. Griendling, Ph.D. et al.;Oxidate Stress and Cardiovascular Disease;1997 American Heart Association, Inc.; pp. 3264-3265.
Judith A. Berliner, Ph.D. et al.;Atherosclerosis: Basic Mechanisms;Circulation 91 (9): 2488; pp. 1-26.
Aldons J. Lusis;Atherosclerosis;Insight Review Articles; pp. 233-241.
Michael Aviram;Review of Human Studies on Oxidative Damage and Antioxidant Protection Related to Cardiovascular Diseases;2000 OPA; pp. 85-97.
Bianca Fuhrman et al.;Flavonoids Protect LDL from Oxidation and Attenuate Atherosclerosis;2001 Lippincott Williams & Wilkins; pp. 41-48.
L. Iuliano, MD et al.;Radiolabeled Native Low-Density Lipoprotein Injected Into Patients With Carotid Stenosis Accumulates in Macrophages of Atherosclerotic Plaque Effect of Vitamin E Supplementation;Circulation Mar. 21, 2000, American Heart Association; pp. 1249-1254.
Michael Aviram et al.;Paraoxonase Inhibits High-density Lipoprotein Oxidation and Preserves its Functions;The American Society for Clinical Investigation, Inc. Vol. 101, No. 8, Apr. 1998, pp. 1581-1590.
Mohamad Navab et al.;The Yin and Yang of Oxidation in the Development of the Fatty Streak;1996 American Heart Association; 16:831-842; pp. 1-24.
Michael Aviram et al.;Human Serum Paraxonoases (PON1) Q and R Selectively Decrease Lipid Peroxides in Human Coronary and Carotid Atherosclerotic Lesions PON1 Esterase and Peroxidase-Like Activities;2000 American Heart Associations, Inc.; pp. 2510-2517.
Michael I. Mackness et al.;Protection of Low-density Lipoprotein Against Oxidative Modification by High-density Lipoprotein Associated Paraoxonase;Atherosclerosis 104 (1993) pp. 129-135.
Patricia Langley;Why a Pomegranate?;BMJ Volum 321; Nov. 4, 2000; pp. 1153-1154.
Maria I. Gil et al.;Antioxidant Activity of Pomegranate Juice and Its Relationship with Phenolic Composition and Processing;J. Agric. Food Chem. 2000, 48, pp. 4581-4589.
Michael Aviram et al.;Pomegranate Juice Consumption Reduces Oxidative Stress, Atherogenic Modifications to LDL, and Platelet Aggregation: Studies in Humans and in Atherosclerotic Apolipoprotein E-deficient Mice;The American Journal of Clinical Nutrition; May 2000 Vol. 71 No. 5; pp. 1062-1076.
Michael Aviram;Plasma Lipoprotein Separation by Discontinuous Density Gradient Ultracentrifugation in Hyperlipoproteinemic Patients;Biochemical Medicine, Vol. 30, No. 1, Aug. 1983; pp. 111-118.
Oliver H. Lowry et al.;Protein Measurement With the Folin Phenol Reagent;Department of Pharmacology, Washington University School of Medicine; May 28, 1951; pp. 265-275.
John A. Buege et al.;Microsomal Lipid Peroxidation;Microsomal Electron Transport and Cyt. P-450; pp. 302-310.
H. Esterbauer et al.,Continuous Monitoring of In Vitro Oxidation of Human Low Density Lipo
Aviram Michael
Dornfeld Leslie
Hogan & Hartson LLP
Stewart and Lynda Resnick Revocable Trust
Tate Christopher R.
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