Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
1999-11-17
2004-11-02
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S451000, C424S464000, C424S489000, C424S774000, C424S776000, C424S778000, C424S779000
Reexamination Certificate
active
06811795
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the field of medicine and pharmacology. More particularly, the present invention relates to compositions having therapeutic value comprising extracts of plant material from one or more of
Glinus lotoides, Ruta chalepensis, Hagenia abyssinica
and
Millettia ferruginea
. The compositions of the present invention are useful in the treatment and prevention of cancer and other diseases. The present invention further relates to methods of preparing such compositions, and methods for the treatment and prevention of disease by administration of the compositions to a patient in need thereof.
2. Description of Related Art
Herbal medicine involves the application of plants or plant parts, without chemical processing, as therapeutic agents for the treatment of human disease. The practice of herbal medicine can be traced back to the most ancient cultures, with some remedies known for thousands of years, and remains the primary form of medicine practiced by many groups today. Much of modem pharmacology is based on herbal medicine, with plant-derived compounds accounting for one quarter of pharmaceuticals (Foster, S, Duke, JA, Eastern/Central Medicinal Plants (Peterson Field Guides), Boston, Houghton Mifflin (1990), vii.). Common plant-derived pharmaceuticals include, for example, digoxin (
Digitalis lanata
), oral contraceptives (progestin derived from
Diascorea villosa
) and cephalosporins (
Cephalosporium acermonium
).
In the last twenty years, there has been a resurgence of interest in herbal medicine (Fugh-Berman, A., Clinical Trials of Herbs, in Primary Care 24: Complementary and Alternative Therapies in Primary Care, 889-903 (John L. Randall and Joel S. Lazar, eds.,1997)); (Lozoya, X., Ciba Found Symp (1994) 185: 130-40). Much of this interest is attributable to a growing awareness that the diversity of the plant kingdom represents a vast (and potentially endangered) resource for the discovery of novel pharmaceuticals (Akerele, O., World Health Forum (1993) 14: 390-5). One study, for example, notes that the 119 drugs of known structure that are produced commercially from plants account for only 90 species of higher plants (Farnsworth, N., Ciba Found Symp (1990) 154: 2-11). With estimates of the total number of species in the world's flora ranging from 250,000 to 500,000 (and possibly greater), the possibilities are evident (Ayensu, E., Endangered Plants in the United States, Smithsonian Institution Press, 1978). The World Health Organization (WHO) has recognized this potential and made a significant policy commitment to encouraging the study of ethnobotany as a way to efficiently identify plants containing bioactive components.
Renewed interest in herbal medicine can also be attributed to another phenomena—a growth of interest in complementary or alternative medicine (Eisenberg, D. et al., JAMA (1998) 280: 1569-75). Studies suggest that between 30 and 50 percent of the adult population in industrialized nations use some form of complementary and/or alternative medicine to prevent or treat a wide variety of health problems (Astin, J. et al., Arch Inter Med (1998) 158: 2303-10). Herbal medicine is among the most popular forms of complementary or alternative medicine, and its popularity has risen in parallel to that of complementary or alternative medicine. One study indicates that more than one third of Americans use herbs for health purposes (O'Hara et al., Arch Fam Med (1998) 7: 523-36). Medicinal plants and plant products may be used in lieu of mainstream therapies, but are often used in conjunction with traditional remedies. Herbal medicine is perhaps even more popular in Europe, where patients have been active in demanding natural alternatives to synthetic drugs (Harrison, P., CMAJ (1998) 158: 637-9).
The increased demand for herbal medicine reflects the public's desire for more natural, effective or safer methods for treating disease. Widespread and increasing use of herbal remedies has been reported, for example, for inflammatory bowel disease (Rawsthorne, P. et al., Am J Gastroenterol (1999) 94: 1298-303); musculoskeletal disorders such as rheumatoid arthritis (Chandola, A. et al., J R Soc Med (1999) 92: 13-16; and HIV-related diseases (Ostrow, M. et al., J Acquire Immune Defic Syndr Human Retroviral (1997) 15: 115-20).
A variety of plants have been identified for their potential use as treatments for these diseases, among others. Plant extracts identified as potential HIV-inhibitors include, for example, Labiatae (Yamasaki, K. et al., Biol Pharm Bull (1998) 21: 29-33)
Prunella vulgari
(Yao, X. et al., Virology (1992) 187: 56-62);
Coptis chineusis, Ligusticum wallichii, Illicium lanceolatum, Isatis tinctoria, Lonicera japonica, Salvia miltiorrhiza, Eyrcibe obstusifolia, Acanthopanax graciliatylus, Bostaurus domesticus, Scutellaria baicaleusis
, and
Inula helenium
(U.S. Pat. No. 5,178,865). Chinese herbs, including Schizandrae, have proven beneficial in the treatment of chronic viral hepatitis (Sinclair, S., Altern Med Rev (1998) 3: 338-44).
Many herbal remedies are now being subject to clinical trials (Klepser, T. et al., Am J Health System Pharm (1999) 56: 125-38); (Fugh-Berman, A., Clinical Trials of Herbs, in Primary Care 24: Complementary and Alternative Therapies in Primary Care, 889-903 (John L. Randall and Joel S. Lazar, eds.,1997). Several medicinal plants have shown good results clinically, including
Hypercium performatum
(for depression);
Allium sativum
(hypercholesterolemia);
Emblica officinalis
(for hypercholesterolemia);
Tanacetum parthenium
(for migraines);
Ginkgo bilboa
(for dementia);
Artemisia annua
(for malaria and other parasites);
Zingiber officinale
(for nausea and emesis); and a variety of Chinese herbs (for HIV).
Perhaps nowhere is a greater desire for safer, more effective remedies seen than in the search for cancer treatments. An estimated 1.2 million new cases of invasive cancer will be diagnosed in the United States in 1999 (Landis, S. et al., CA Cancer J Clin (1999) 49: 8-31). Breast cancer alone will account for approximately 29% of these new cases. Plants and plant derived compounds have received attention as possible sources of novel therapeutics for cancer. Much of the work in this area is done under the auspices of the National Cancer Institute, which maintains an active screening program for medicinal plants (Cragg, G. et al., Ciba Found Symp (1994) 185: 178-90); (Cragg, G. et al., J Nat Prod (1993) 56: 1657-68). Plants and plant compositions identified as having potential for the treatment and/or prevention of cancer include extracts from the genus Geranium and Plantago and the species Calendula officinialis (PCT Application No. WO 98/24458); Peganum Harmala L. and Drakocephalum Kotshyi Boss. (PCT Application No. WO 99/24048);
Echinops spinosus
L. (PCT Application No. WO 99/24047); safflower extract (PCT Application No. WO 98/44005);
Portulaca oleracea
(PCT Application No. WO 98/24457);
Agaricus blazei
Murill (PCT Application WO 98/27992);
Solanum muricatum
(CSG) (Ren et al., Anticancer Res (1999) 19: 403-8); and
Beta vulgaris
(beet) (Kapadia et al., Cancer Lett (1996) 100: 211-4). Yet, the need for identification of suitable therapeutics remains high.
The present invention relates compositions and methods for the prevention and treatment of cancer and other diseases. The compositions of the present invention comprise extracts of plant material from
Glinus lotoides, Ruta chalepensis, Hagenia abyssinica
, and
Millettia ferruginea
, either alone or in combination. All four plants grow in the Waynadega region of Ethiopia where the rainfall is sufficient for vegetative growth. The use of at least several of these plants is known in indigenous cultures, though not in the form of the presently claimed composition nor for the claimed medicinal uses.
The plant
Glinus lotoides
, more commonly known as Mettre or, in Arabic, as Moghera, grows ubiquitously in the Allaqi area, south of Aswan, Egypt (Hamed et al.
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