Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1998-02-27
2001-07-03
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S002600, C514S025000, C514S045000, C514S047000, C514S054000, C546S348000, C549S315000
Reexamination Certificate
active
06255291
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a composition for treating early stages of various forms of malignancies, particularly melanoma and lung cancer, in mammals. In more advanced stages of malignancies, such as those involving larger tumors and/or metastases, the composition is designed to be used as an adjunct and adjuvant therapy with other procedures such as surgery, chemotherapy, radiation therapy, antibody therapy, and others. The composition can also be used for treating various immunological disorders resulting in chronic conditions, especially those leading to inflammatory events, such as rheumatoid arthritis, cystic fibrosis, psoriasis, and pleural disease.
BACKGROUND OF THE INVENTION
Cancer afflicts many individuals each year. Melanoma tumors, for instance, originate from melanocytes, pigment cells that are normally present in the epidermis and sometimes in the dermis. Melanoma affects about 28,000 individuals yearly in the United States and kills about 5,800 of these individuals. Melanoma incidence has increased dramatically (700% in the last 40 years). If the incidence continues to increase at the present rate, risk of melanoma will approximate about 1 percent within a decade lifetime.
There are various types of malignant neoplasm affecting the lung, such as adenosquamous carcinoma, small cell (oat cell) carcinoma, large cell carcinoma, and others. These malignancies can affect various parts of the lung and can be classified into several types depending on the site, such as alveoral carcinoma, bronchiolar carcinoma, bronchogenic carcinoma, and others. In general, malignancies of the lung account forthe highest incidence of cancer in the United States. At the same time, the various forms of lung cancer account for the highest death rates.
Immune system is involved in a pathologic process called inflammation, which is a complex of cytologic and chemical reactions occurring in the tissues and blood vessels in response to an injury or abnormal stimulation. Inflammation is usually a relatively quick response with a rapid onset. Sometimes, however, the inflammatory response is insufficient, allowing the persistence of the injuring agent or its products in the tissues, resulting in chronic inflammation. Some cell-mediated inflammatory mechanisms may be directed towards autoantigens causing chronic tissue-damaging inflammation. Types of such chronic inflammations include rheumatoid arthritis, psoriasis, Chrohn's disease, cystic fibrosis, and others.
Immunomodulating compositions have been designed to treat various immunodeficiencies and autoimmunological disorders. Ongoing research continues to evaluate whether these compositions may be useful in treating one or more malignant diseases.
Greek Patent Specification No. 72,440 discloses an immunomodulating composition containing a mixture of D-ribose, DL-alpha alanine, nicotinic acid and ascorbic acid. The composition asserted to have a pronounced immunomodulating activity and to be able to rebuild the metabolic equilibrium and strengthen the immunity of an affected mammal.
PCT application CZ94/00015, filed Jul. 12, 1994, and U.S. Ser. No. 08/564,328 (the U.S. equivalent to the PCT application) disclose an improvement upon the Greek patent and incorporate 2-deoxy-D-ribose, thiamin, and glutamic acid amide therein. The resulting improved composition has been found useful in immunomodulating and adjuvant therapy in combination with a metabolic stressor.
Co-pending U.S. patent application Ser. No. 08/787,209, discloses a composition of a ribose compound, L-beta-alanine, ascorbic acid, and nicotinic acid, and adenosine-5′-monophosphate disodium salt.
It has now been unexpectedly discovered that adding an adenosine compound and a glucan to the alpha-alanine-containing compositions of PCT application CZ94/00015 significantly enhances a mammal's resistance to cancer, particularly melanoma and lung cancer, and significantly enhances the mammal's immunological response.
It is an object of this invention to make a composition which will enhance a mammal's resistance to cancer and prolong that mammal's life.
It is a further object of this invention to produce a composition that inhibits the growth of a cancer tumor.
It is a further object of this invention to treat a mammal with cancer by introducing the composition into the bloodstream of the mammal.
It is a further object of this invention to produce a composition that enhances the immunological response of the organism.
It is a further object of this invention to stimulate a mammal's immune system response by introducing the composition orally into the stomach of the mammal.
These and still further objects will be apparent from the following description of this invention.
SUMMARY OF THE INVENTION
The present invention is directed to a composition containing alpha-alanine. The composition preferably comprises alpha-alanine, an adenosine compound, a ribose compound, ascorbic acid, and nicotinic acid. More preferably the composition comprises alpha-alanine, an adenosine compound, ribose compounds, ascorbic acid, nicotinic acid, and a glucan. The composition may be prepared in a soluble form in a sodium chloride (saline solution) solution or in a particulate form by blending all of the compounds into a dry, homogenous mixture. The present invention also includes a method for treating cancer tumors in mammals by introducing the composition into the bloodstream of the mammal. The present invention further includes a method for curing cancer involving the steps of (i) introducing a composition of this invention into a mammal and (ii) removing a cancer tumor from a mammal. The present invention also includes a method for stimulating an immune response in mammals by introducing the composition orally into the stomach of the mammal.
REFERENCES:
patent: 5118673 (1992-06-01), Carpenter et al.
patent: 5672590 (1997-09-01), Kufudaki
patent: 5747474 (1998-05-01), Ojo-Amaize et al.
patent: 9726893 (1997-07-01), None
Jacobs Bruce F.
Peregrine Pharmaceuticals, Inc.
Wilson James O.
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