Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1998-08-07
2001-02-13
Goldberg, Jerome D. (Department: 1614)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C514S025000
Reexamination Certificate
active
06187315
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a pharmaceutical composition comprising tannic acid or tannin complexes, and a method of treating cancer with tannic acid or tannin complexes.
BACKGROUND OF THE INVENTION
Tannic acid and tannin complexes are found in the trunk of any of the plants of the Musaceae Family, i.e.,
Musa Paradisiaca, Musa Cavendish Enano,
and related Linnaean classifications.
Tannic acid is known to be useful in a diagnostic test for the detection of cancer. For example, Macartney et al. in i J. Pathol. (ENGLAND) September 1979, 129 (1) p. 13-20, “Intracellular filaments in human cancer cells: a histological study”, discloses that the distribution of intracellular filamentous systems in human breast and colon cancers has been demonstrated by means of the tannic acid-phosphomolybdic acid-milling dye staining technique. Plasma membrane-associated staining is prominent in breast carcinomas and is strongest in anaplastic tumors. Strong staining is also noted in the cells at the margins of the tumors where the malignant cells are invading the surrounding tissues. In colon carcinomas, filaments are mainly restricted to the terminal web region of the cells but dedifferentiation is accompanied by the development of circumferential staining of the cell membrane. The results are discussed in relation to immunohistochemical and electron microscopic studies of contractile proteins in non-muscle cells.
Harlos et al. in
J. Cancer
(DENMARK) Apr. 15, 1978, 21 (4) p. 413-7, discloses a “Comparison between the macrophage electrophoretic mobility (MEM) and the fixed tanned erythrocyte electrophoretic mobility (FTEEM) tests in the detection of cancer.” When peripheral lymphocytes from patients with a history of cancer are incubated with encephalitogenic factor (EF), in 90% of cases the resulting products reduce the net surface negativity of guinea-pig macrophages, used as detector cells, as revealed in the macrophage electrophoretic mobility (MEM) test. The MEM test is positive in 36% of people with no history of cancer. Formaldehyde-fixed tanned sheep erythrocytes have been used as detector cells in place of guinea-pig macrophages, in a fixed tanned erythrocyte electrophoretic mobility (FTEEM) test, with lymphocyte products identical to those used in MEM tests. In patients with a history of cancer, positive results were obtained in 28 of 42 cases with the FTEEM test compared with 32 of 42 in the MEM test. In people with no history of cancer, negative results were obtained in 16 of 18 cases with the FTEEM test, compared with 12 of 18 in the MEM test in the present series, and 51 of 69 in a more extensive series. These differences are not significant. Cases in which discrepancies are revealed between the two tests are discussed in terms of individual case histories.
Tannic acid has been shown to inhibit 12-O-tetra-decanoyl-phorbol-13-acetate (TPA) tumor promotion. Perchellet et al.,
Basic Life Sci.
(UNITED STATES) 1992, 59 p. 783-801, discloses that naturally occurring plant phenols with antimutagenic and anticarcinogenic activities were tested for their abilities to inhibit the biochemical and biological effects of the potent tumor promoter 12-O-tetradecanoyl-phorbol-13-acetate (TPA) in mouse epidermis in vivo. When applied topically to mouse skin, tannic acid (TA), ellagic acid, and several gallic acid derivatives all inhibited TPA-induced ornithine decarboxylase activity, hydroperoxide production, and DNA synthesis, three biochemical markers of skin tumor promotion. In a two-step initiation-promotion protocol, the same phenolic compounds also inhibited the incidence and yield of skin tumors promoted by TPA.
Ramanathan et al. in “Cytotoxic effect of plant polyphenols and fat-soluble vitamins on malignant human cultured cells”,
Cancer Lett.
(NETHERLANDS) Mar. 15, 1992, 62 (3) p. 217-24, discloses in vitro studies which showed that several flavonoids, tannic acid, gallic acid and fat-soluble vitamins inhibited HeLa and Raji lymphoma cell growth. The inhibition trend exhibited by these compounds was similar for both cell lines, and their growth was inhibited dose dependently. Butein, (10 microM), the most potent anti-proliferative agent, exerted 30% growth inhibition and was more effective on HeLa cells. Retinol (100 microM) inhibited cell proliferation completely. Tannic acid was twice as potent as its monomer gallic acid. From structure-activity consideration, the C 2,3-double bond of the flavonoid molecule was important for activity. Flavonoid aglycones were more effective than their corresponding glycosides in suppressing cell growth in vitro. No in vivo results were presented.
Athar et al., “Effect of dietary tannic acid on epidermal, lung, and forestomach polycyclic aromatic hydrocarbon metabolism and tumorigenicity in Sencar mice,”
Cancer Res.
(UNITED STATES) Nov. 1, 1989, 49 (21) p. 5784-8, discloses tannic acid inhibits the mutagenicity of several polycyclic aromatic hydrocarbons (PAHs) and their bay-region diol-epoxides. Studies have shown that when applied topically to Sencar mice, tannic acid caused substantial inhibition of epidermal PAH metabolism, subsequent PAH-DNA adduct formation, and PAH-induced skin tumorigenesis. None of the above publications discloses that tannic acid is useful for the treatment of cancer.
Current standard cancer treatments include surgery, chemotherapy and radiation therapy, which often present patients with unpleasant side effects and, depending on the type of cancer may have limited effectiveness as treatments.
There is a need in the art for proven effective treatments for many types of cancer, with limited unpleasant side effects. The tannic acid pharmaceutical composition and method of the present invention overcomes the deficiencies in the prior art compounds.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a pharmaceutical composition for the treatment of cancer comprising tannic acid or tannin complexes from the sap of a plant of the Musaceae Family and a pharmaceutically acceptable carrier. The plant is preferably selected from the group consisting of
Musa paradisiaca
(plantain);
Musa Cavendish Enano
(banana), varieties and mixtures thereof.
It is an object of the present invention to provide a method of treating cancer comprising administering an effective amount of a pharmaceutical composition comprising tannic acid or tannin complexes from natural or synthetic sources. It is preferred that the pharmaceutical composition is administered at least once daily, and more preferred that the composition is administered four times daily.
The pharmaceutical composition of the invention is advantageously used to treat any cancer condition. It is to be understood that the invention includes a method of making a medicament for treating cancer. The invention includes a pharmaceutical composition comprising tannic acid, comprising a tannin complex, and treatment of a cancer patient with a composition in accordance with the invention.
Types of cancer which may be treated with the composition and method of the present invention include, but are not limited to the following: Nasal cavity, paranasal sinus, nasopharynx, oral cavity and oropharynx squamous cell carcinomas and adenocarcinomas; oral lymphomas; adenoid cystic carcinoma; paragangliomas; squamous cell carcinoma, adenocarcinoma, large cell (undifferentiated) carcinoma, and small cell carcinoma of the lung; mediastinal thymomas, lymphomas and neurogenic carcinomas; squamous cell carcinoma and adenocarcinoma of the esophagus; adenocarcinoma of the stomach; ductal adenocarcinoma, mucinous cystadenocarcinoma, acinar cell carcinoma, unclassified large cell carcinoma, small cell carcinoma, and pancreatoblastoma of the pancreas; hepatocellular carcinoma, hepatoblastoma, cholangiocarcinoma, cholangiocellular carcinoma, cystadenocarcinoma, squamous cell carcinoma, angiosarcoma, hemangioendothelioma, leiomyosarcoma, malignant schwannoma, fibrosarcoma, malignant fibrous histiocytoma, lymphoma, osteosarcoma, rhabdomyosarcoma and mesenchymal sa
Atajje, Inc.
Goldberg Jerome D.
Hamilton LLP Pepper
Villacorta Gilberto M.
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