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01/25/07 | 94 views | #20070021326 | Prev - Next | USPTO Class 514 | About this Page  514 rss/xml feed  monitor keywords

Composition and its therapeutic use

USPTO Application #: 20070021326
Title: Composition and its therapeutic use
Abstract: A composition having a variety of therapeutic and cosmetic uses comprises: (i) a vitamin; (ii) a metal salt that provides metal ions in vivo; and (iii) insulin or a growth hormone. Such a composition is useful for treating, for example, genetic disorders, skin diseases, cancer and viral infections. (end of abstract)
Agent: Mcdonnell Boehnen Hulbert & Berghoff LLP - Chicago, IL, US
Inventors: Mishal Hamid, Rafeda M. A. Younis, Karam M. H. Al Sari, Saad M. H. Al Sari, Ahmad M. H. Al Sari
USPTO Applicaton #: 20070021326 - Class: 514003000 (USPTO)
Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) Doai, Insulin Or Derivative
The Patent Description & Claims data below is from USPTO Patent Application 20070021326.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

[0001] This application claims priority to U.S. Provisional Application Ser. No. 60/407,373, filed Aug. 30, 2002, and to Great Britain Application No. GB 0212405.5, filed May 29, 2002, the disclosures of which are incorporated herein in their entirety.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates to a composition comprising primarily natural products and to its use in therapy, especially of genetic disorders, viral diseases, cancer and AIDS. The composition is also useful as a cosmetic.

[0004] 2. Description of the Related Art

[0005] Despite decades of research, the treatment of cancer remains unsatisfactory. Surgery may be used to remove a solid tumour, but metastasis or recurrence of the cancer is common. Treatment with drugs, or chemotherapy, is usually non-specific, and is associated with undesirable side-effects, including damage to the immune system. Cell destruction by cytotoxic drugs follows first order kinetics, i.e. it reduces a constant percentage and not a constant number of cancer cells. Thus, the same dose which reduces the number of cancer cells from 10.sup.8 to 10.sup.7 is required to reduce the number from 10.sup.3 to 10.sup.2. Therefore, it is difficult to eradicate the last portion of any tumour solely by chemotherapy without causing serious toxicity.

[0006] Radiotherapy may be more localised, but is still dangerous to the patient and cannot avoid recurrence; the very localisation of the treatment means that there may be many cancerous or pre-cancerous cells that are unaffected by it, even if damage to healthy cells can be avoided. Surgery, radiation treatment and chemotherapy all leave residual tumour tissue following the completion of therapy. Both radiotherapy and chemotherapy depress the immune system of the patient which can in turn reduce the effectiveness of any treatment.

[0007] Similarly, the treatment of AIDS remains unsatisfactory. Drug treatment can provide some remission of symptoms, but is liable to cause side-effects. Thus, there is no effective long-term treatment. Further, the fact that AIDS patients are immuno-compromised remains a major problem for conventional therapy.

[0008] In addition to cancer and AIDS, there are many conditions that can only be addressed by chemotherapy associated with side-effects, owing to the unspecific nature of the drugs that are used. These conditions include skin diseases such as psoriasis, pemphigus and scleroderma. Further, there are veterinary conditions where there is no effective treatment, including Newcastle disease.

[0009] Conditions of the type described above may be associated with a genetic disorder, e.g. some failure in the process whereby genes are translated into proteins, in vivo. It is known that a change of just one amino acid in a protein may be associated with disease, e.g. as in sickle cell anaemia. Proliferative conditions and cancer, among others, may be associated with an error in the sequence of events leading from organisation of genes to production of protein.

SUMMARY OF THE INVENTION

[0010] The present invention is based on the surprising discovery that the use of one or more natural products, i.e. materials that are present in the body in vivo or are at least well tolerated by it, are effective in the treatment of diseases of the type described above. The nature of the materials is such that the novel medicament can be administered systemically, without causing major side-effects. Nevertheless, the effect of the medicament may be enhanced or supported by the use of certain further materials.

[0011] According to the present invention, a medicament comprises one or more of the following components:

[0012] (i) an antioxidant or vitamin;

[0013] (ii) metal ions; and

[0014] (iii) an agent that enhances the ability of a cell to take up extracellular components.

[0015] As will be evident from the data presented below, the use of all the given components in combination is of remarkable utility in therapy. It will be appreciated by one skilled in the art that the effect of these components may be independent or interdependent, and that this is not inconsistent with the nature of the discovery that has been made. Thus, it will be appreciated that an effective agent for use in therapy, according to the present invention, may comprise only one of the given components (i), (ii) and (iii), or any combination of them, i.e. (i) and (ii), (i) and (iii), (ii) and (iii) or (i), (ii) and (iii). Alternatively or in addition, it may comprise one or more of these components in combination with any other component described herein, e.g. an aqueous composition comprising camomile, for injection, or a combination of antioxidant and antihistamine.

[0016] The invention has, as an object, the avoidance of gene mutation, and the prevention of rapid reproduction of mutated cells.

[0017] Without wishing to be bound by theory, the effect of the components used in the present invention may be to regulate and/or correct the steps leading to expression of proteins, e.g. in immuno-compromised cells, in tumours or in cells that are otherwise acting abnormally. For example, it may be that a component such as component (i) "normalises" cells, possibly by correcting a differentiation gene or by activating a gene that lyses abnormal cells. According to the invention, this component is provided in a form that can act on the affected cells. The possibility that cells are normalised would help explain why cells that are already normal remain unaffected, i.e. the absence of side-effects, and why use of the composition does not change cancer cells (as observed visually) but renders them benign, and why metastasis is inhibited.

[0018] In cancer, toxic materials may indirectly affect a gene, leading to errors in nucleic acid translation and to errors in the cell. Provision of component (i) may allow the cell or its components to function normally. Genes that are responsible for differentiation may be corrected or, if not corrected, a suicide gene is unmasked, and lyses tumour cells.

[0019] In other genetic disorders, e.g. caused by viral infection, a foreign body interacts with the membrane or receptor, or enters the cell and causes local chemical or physical changes. A genetic disorder may be introduced or a genetic abnormality may be present. The present invention can prevent the virus from penetrating the cell membrane, or can destroy the virus. An abnormality in the membrane or receptor can be corrected. A normalised cell is not susceptible to the virus which is then destroyed by phagocytosis, stimulated and enhanced by opsonisation.

DETAILED DESCRIPTION OF THE INVENTION

[0020] The first of the given components of a composition of the invention is an antioxidant. The function of this component may be to prevent the formation of S--S bridges by oxidation of cysteine residues. Disulfide linkages are caused by many oxidising agents, and cause loss of enzymatic activity. Alternatively or in addition, the antioxidant may inhibit the production of oxygen radicals (free radicals) as a by-product of the normal metabolism of oxygen. These oxygen radicals are very damaging to cell membranes, proteins, lipids and DNA. Oxidative damage accumulates with age and is considered to be a major contributor to ageing and the development of degenerative diseases (e.g. cancer, cardiovascular disease, immune system decline, etc).

[0021] Suitable antioxidants for use in the invention are small molecules such as vitamin C, A and E. It will be appreciated that a suitable precursor of any such compound may be used, e.g. .beta.-carotene. The preferred antioxidant for use in this invention is vitamin C, e.g. as ascorbic acid. A suitable dosage of this component is 1 to 500 mg/kg/day.

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