Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1996-09-25
2001-07-10
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
Reexamination Certificate
active
06258847
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed to new therapeutic compositions and applications of 2-mercaptoethanolamine (2-MEA) and related aminothiols and di-isopropyl salicylates, solely or in combination with other factors, agents, or processes that are physical, chemical and/or biological based, including precursors, intermediates, end products, catalysts, promoters and/or any factors, agents, or processes involved directly or indirectly from initial application of the therapy to the final result. More particularly, the present invention is directed to the use of 2-MEA and related aminothiols and copper(II)-3,5 di-isopropyl salicylate in the treatment and prevention of AIDS, cancer, autoimmune disease, microbiological infections, and other diseases where immunological dysfunction and/or free radical formation function as part of the disease mechanism.
2-MEA has long been used by itself in the treatment of kidney disease, known as cysteinuria, where it may protect renal function. 2-MEA and related compounds have also been used as radiation protective agents in various formulations. This is at least due in part to the powerful antioxidant properties of these compounds. 2-MEA has also been linked with ulcerogenic properties in animal experiments. 2-MEA has been shown to exert both immunostimulant and immunomodulant action in in vitro trials. Jeitner et al., Biochimica et Biophysica Acta 1223:15-22 (1994). Cystamine, a related compound, has demonstrated in vitro inhibition of HIV. Bergamini et al., J. Clin. Invest. 93:2251-2257 (1994). Other applications of 2-MEA have been in the field of non-specific vitamin supplementation as a general antioxidant supplement in Swedish Anti-Aging Formula 223.
SUMMARY OF THE INVENTION
The antioxidant abilities of 2-MEA and related aminothiols make these compounds a valuable therapeutic adjunct to the treatment of any disease condition which directly or indirectly generates or causes the generation of free radicals. Essentially, this includes virtually every known disease condition as well as other conditions which may not be commonly regarded as diseases, as well as conditions which may be predisposed to or function as pre-cursors to disease. Although it is contemplated that the present invention include all such applications singly or in combination with other traditional therapies, there are several disease conditions where the application has produced significant results with the use of 2-MEA singly, or in combination with other factors, agents and/or processes. These diseases include AIDS, cancer, autoimmune disease, microbiological infections, and other diseases where immunological dysfunction and/or free radical formation function as part of the disease mechanism.
In the present invention, 2-MEA and related aminothiols are used in cancer prevention and treatment as a general immunostimulant and/or as an antioxidant to offset some of the toxic sequelae of the disease condition or other conventional therapies such as chemotherapy and radiotherapy. It is important in the application of 2-MEA and related aminothiols to either bind the compound to a delivery system which directs its protective action preferentially to healthy cells and/or time its delivery so as not to interfere with the anticancer activity of the therapy. A therapy may be beneficial to the body and antagonistic to the disease if timed correctly. If antioxidants like 2-MEA, for example, are timed correctly so as to inhibit or otherwise interfere with agents used in therapy which generate free radicals, then the previously antagonistic therapy may now protect disease by interfering with therapy and may now be classified as synergistic.
Application to autoimmune and immunodeficient conditions is indicated by the immunoregulating and immunomodulating activity demonstrated by 2-MEA. 2-MEA and related aminothiols including penicillamine and/or copper(II)-3,5-di-isopropyl salicylate were administered to patients as single agents, or in combination with other factors, agents, or processes which induced, stimulated, and/or facilitated their efficacy, or inhibited, suppressed or neutralized their toxic or undesired effects. Some agents and factors may have dual capabilities.
Although 2-MEA and related aminothiols may be incorporated in many uses requiring its antioxidant capabilities of other properties, the present invention is directed primarily to the medical applications of 2-MEA. The use of 2-MEA in the present invention impacts on diseases as varied as AIDS, systemic lupus erythromatosus, cancer, arthritis, autoimmune diseases, and can be used in sunscreens to minimize radiation damage.
Cimetidine, for example, may directly aid in the immunostimulating or immunomodulating action of 2-MEA while inhibiting ulcer formation. Copper(II)-3,5 di-isopropyl salicylate directly supports the antioxidant ability of 2-MEA while indirectly assisting in the treatment of cancer, for example, by having its own anti-cancer activity.
A therapeutic composition and method is disclosed for using 2-MEA and related aminothiols in the treatment and prevention of AIDS, cancer, autoimmune diseases, and microbiological infections, comprising the step of administering an effective dosage of a therapeutic composition comprising 2-MEA or related aminothiols to a patient having AIDS, cancer, autoimmune disease, microbiological infections, and other diseases where immunological dysfunction and/or free radical formation function as part of the disease mechanism. The effective dosage of 2-MEA or related aminothiols for administration to a patient is between approximately 0.01 mg and about 500 mg, at least once daily, up to four times a day. However, benefits may be achieved with a single dose, a monthly dose or a weekly dose. However, 2-MEA efficacy is best sustained with a daily dosage. The therapeutic composition is administered to a patient by a means selected from the group consisting of oral administration, catheter administration, intramuscular administration, intravenous administration, intradermal administration, intradural administration, intravesical administration, intraurethral administration, intrathecal administration, inhalation, topical administration, sub-cutaneous administration, and rectal administration or any other means of administration. The composition is orally administered in a form selected from the group consisting of a capsule, gel cap, liquid, tablet.
In yet another method of the present invention, 2-MEA and related aminothiols were combined with a living biological delivery system. 2-MEA or related aminothiols were incubated with a living biological system to form a mixture. The mixture was centrifuged to produce a pellet comprising the 2-MEA, the active ingredient, bound with the living biological system. The pellet may also include intermediates and/or end products of 2-MEA or related aminothiols depending on the precursor used. The pellet was administered as is or, was re-suspended and washed at least once. The pellet was then administered to patients.
The living biological system is selected from the group consisting of yeast, lactic acid cultures, target cells, and other living cells. 2-MEA or related arninothiols and the living biological system were incubated between about 6 hours and about 72 hours depending on the type of living biological system. For example, yeast or yogurt cultures were incubated between about 6 hours and about 48 hours, lactic acid cultures were incubated between about 24 and about 48 hours, and target cells and other living cells were incubated between about 24 and 72 hours. The centrifuging step was performed from about 200 rpm to about 50,000 rpm.
Different centrifugation rates isolate specific components. Ultracentrifugation was sometimes employed after lysis of cell to recover and concentrate organelles and other fractions for use in the invention.
When 2-MEA and related aminothiols are combined with a living biological delivery system, the pellet can be administered to patients in several ways. First, the pellet can be orally ad
Travers Russell
Whitlock Ted W.
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