Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Utility Patent
1999-06-07
2001-01-02
Tate, Christopher (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
Utility Patent
active
06168795
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of using an herbal extract-based composition in therapy against tumors. More particularly, provided is a method of anticancer therapy comprising administering either a therapeutically effective amount, or a prophylactically effective amount, of a composition comprising an extract of
Gynostemma pentaphyllum,
an extract of
Crataegus pinnatifida,
and an extract of
Camellia sinensis.
BACKGROUND OF THE INVENTION
Any one individual is at risk of developing cancer. The occurrence of cancer increases with aging over a life time (“lifetime risk”). For example, in the U.S., men have a 1 in 2 lifetime risk of developing cancer, and women have a 1 in 3 risk. Other risk factors are believed to include genetics, diet, and environmental exposure (e.g., to mutagenic chemicals, radiation, transforming viruses, etc.). It is estimated by the World Health Organization that about 10 million new cancer cases are occurring now annually around the world. That number is expected to reach 15 million by the year 2015, with two thirds of these new cases occurring in developing countries (
World Health
48:22, 1995). For example, it is estimated that there is about 600,000 new cases of lung cancer per year worldwide; approaching 1 million new cases of breast cancer per year; and for head and neck cancer (the sixth most frequently occurring cancer worldwide) an incidence of 500,000 new cases annually. The National Cancer Institute estimates the overall annual costs for cancer at $107 billion. Treatment costs account for approximately $40 billion.
While new therapeutics are being developed and tested for efficacy against tumors, many of the currently available cancer treatments are relatively ineffective. It has been reported that chemotherapy results in a durable response in only 4% of treated patients, and substantially prolongs the life of only an additional 3% of patients with advanced cancer (Smith et al., 1993,
J. Natl. Cancer Inst.
85:1460-1474). Many of the current anticancer drugs are both cost-prohibitive, and present with major toxicity. Regarding the latter and depending on the drug or drug combination used, systemic chemotherapy may result in one or more toxicities including hematologic, vascular, neural, gastrointestinal, renal, pulmonary, otologic, and lethal. For example, tamoxifen has been used in women for 25 years to limit breast cancer recurrence. A trial launched in 1992 has shown that tamoxifen is not only effective as a therapeutic agent, but also has a very substantial benefit in cancer prevention (a breast cancer preventative agent). However, in that study, tamoxifen use was shown to have adverse effects in healthy women; i.e., an increased risk of developing uterine cancer or pulmonary blood clots (
Science News,
1998, 153:228).
Hence, a need still exists for a relatively cost-effective and efficient method for inhibiting growth of tumors, but ameliorate toxicity generally associated with systemic chemotherapy.
SUMMARY OF THE INVENTION
This invention relates to the use of a composition as an anticancer agent for treating cancer in an individual. The composition comprises about 10 to about 30 percent by weight of
Gynostemma pentaphyllum
extract, about 10 to about 30 percent by weight of green tea extract, and about 40 to about 75 percent by weight of hawthorn berries extract. The preferred composition comprising about 10 to about 30 percent by weight of a mixture of an aqueous extract and an alcohol extract of
Gynostemma pentaphyllum,
about 10 to about 30 percent by weight of a mixture of an aqueous extract and an alcohol extract of
Camellia sinensis
(green tea), and about 40 to about 75 percent by weight of a mixture of an aqueous extract and an alcohol extract of
Crataegus pinnatifida
(hawthorn berries). The composition, and a method of making the same is the subject of co-pending and allowed U.S. Pat. No. 5,910,308 (the subject matter of which is herein incorporated by reference) by the present inventor. In one embodiment, this method comprises administering a therapeutically effective amount of the composition to an individual (a mammal; and in a preferred embodiment, a human) bearing a tumor. In another embodiment, the method comprises administering a prophylactically effective amount of the composition to an individual to prevent tumor development (e.g., in an individual who is at high risk for developing tumor; or in an individual who is in remission, but at risk for recurrence).
Thus, a primary object of the present invention is to provide a method for treatment of a tumor bearing individual by administering a therapeutically effective amount of a composition having a property of inhibiting tumor growth when administered to the tumor bearing individual.
Another object of the present invention is to provide a method for prevention of tumor development in an individual at risk for tumor development by administering a prophylactically effective amount of a composition having a property of inhibiting tumor growth when administered to the individual.
Another object of the present invention is to provide a method of treatment of a tumor bearing individual, or an individual at risk for developing tumor, with a therapeutically effective amount of a composition that has both properties of inhibiting tumor growth, and being substantially non-toxic when administered to the individual. “Substantially nontoxic” means that the composition lacks the toxicity generally associated with systemic chemotherapy; i.e., lacks detectable toxicities including hematologic, vascular, neural, gastrointestinal, renal, pulmonary, otologic, and immunosuppression (which may lead to lethal infections).
A further object of the present invention is to provide a method of treatment of an individual who has had a substantial reduction in tumor burden but who still is at risk for recurrence, wherein the method comprises administering to the individual a prophylactically effective amount of a composition that has both properties of inhibiting tumor growth, and being substantially non-toxic when administered to the individual.
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Ahn et al. Planta Med. vol. 64 (5), pp. 468-470, abstract enclosed, May 1998.
Paschka et al., “Induction of apoptosis in prostate cancer cell lines by the green tea component, (-)epigallocatechin-3-gallate”, Aug. 14, 1998, Cancer Letters, vol. 130, pp. 1-7.
Nelson M. Bud
Sant{acute over (e)} International Inc.
Tate Christopher
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