Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-04-30
2001-07-03
Padmanabhan, Sreeni (Department: 1621)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S561000, C514S564000, C514S822000, C514S824000
Reexamination Certificate
active
06255296
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a method and formulation for treating a patient susceptible to or suffering from cardiovascular disorder or disease, and more particularly, but not by way of imitation, to a method and formulation for preventing and treating atherosclerosis, arteriosclerosis, congestive heart failure, arterial stenosis, re-stenosis, re-stenosis, smooth muscle cell hydro trophy, cardiac cell hydro trophy, thrombogenicity, clotting disorders, platelet disorders, myocardial infarction, cerebrovascular ischemic, peripheral vascular ischemic, angina pectoris or hypertension.
BACKGROUND OF THE INVENTION
Cardiovascular disorders and diseases, and their associated complications are a principal cause of disabilities and deaths of individuals in the United States and Western Europe. For example, in recent years more than 500,000 deaths have occurred annually in the United States alone as a result of coronary artery disease, and an additional 700,000 patients have been hospitalized for myocardial infarction.
There has been an ongoing search for effective long term treatment for disorders and diseases of the heart and arteries, such as atherosclerosis, arteriosclerosis, congestive heart failure angina pectoris, and other disorders and diseases associated with the cardiovascular system. Prior treatments for such disorders or diseases include administration of vasodilators, angioplasty and by-pass surgery, for example. Such treatments have met with great disapproval due to the risks versus the benefits gained by the various treatments. Such treatments have serious shortcomings in long term effectiveness. The use of vasodilators drugs and mechanical treatments for acute and chronic occlusive vascular diseases of the heart, central, and peripheral vascular system have to date been ineffective for favorable long term results. The outcome with current treatments is minimally impacted because the treatments are directed toward the effects of the underlying disease process rather than the initial molecular cause of the disease or disorder.
For example, the rationale for vasoactive drugs is to reduce blood pressure by acting directly or indirectly on vascular, and/or cardiac, smooth muscle and thereby decreasing vascular resistance and abnormalities to flow. Such drugs do not treat the initial cause of elevated pressure and abnormal flow. Rather, they seek to reduce the resulting effect of the disease or disorder. Such drugs activate the sympathetic nervous system by way of the baroreceptor reflex to produce an increased heart rate and force of myocardial contraction which are not beneficial effects. Other side effects from such drugs include headache, heart palpitations, anxiety, mild depression, dry-mouth, unpleasant taste in the mouth, nausea, vomiting, angina, myocardial infarction, congestive heart failure, decreased cardiac output, fluid retention, fatigue, weakness and others. Pharmacological treatment of most diseases is not very specific in its effect on the initial molecular cause of the disease activity, and treats a very limited spectrum of effects in diseases which are multifactorial.
As a further example, such improved outcome in atherosclerotic vascular diseases is seen with cholesterol reduction and drug treatment for lipid disorders. However, these treatments do not treat the clotting abnormalities associated with these disease states which are known to be the proximate event causing heart attack and stroke. These do not prevent the cellular or molecular reactions attributed to platelets, macrophages, neutrophils, lymphocytes, smooth muscle cells, and other cell types known to be involved in atherosclerosis and complications of the disease.
Likewise, thrombolytic therapy, angioplasty and by-pass surgery have been minimally successful long term. Current mechanical and pharmacological treatments focus on a particular partial or complete occlusion or occluded vessel where, at the particular site, it is either unclogged or by-passed with connecting vessels. These treatments fail to address the physiologic derangements of normally homeostatic systems which allow the occlusive process to begin and progress. Likewise, they fail to address the multicentric nature of the homeostatic derangements. These failures frequently result in recurrent occlusion in the initially treated vessel, microembolism from incomplete resolution of thrombus at the occlusive site treated, and no treatment for sites not judged to be adequately occluded or stenotic by currently available, crude technologic methods.
There remains a great need for treatment which prevents the failure of the normal homeostatic controls and which restores these controls once derangements begin to develop. Restoration of the endogenous regulatory systems and cellular domains to a healthy state could prevent the stenosis, occlusion, thrombosis, and thromboembolic processes which occur as a consequence of such derangements. Continuous and episodic restoration of control in the normal molecular processes which finely regulate homeostasis can prevent atherosclerosis, variants thereof, hypertension, congestive heart failure, macro and micro-thrombosis and thromboembolism, and complications of these disease processes, including, but not limited to, myocardial infarction, cerebrovascular accident, related kidney diseases, related central and peripheral nervous system disorders, and related diseases in other cellular systems. In addition, rapid restoration of homeostatic control once injurious processes accelerate and accumulate can minimize both the extent of and duration of consequences on atomic, molecular, membrane, cellular, and organ levels.
SUMMARY OF THE INVENTION
It is the conception of the inventor that the cellular matrix composed of heparin-arginine-water polymers is responsible for the controlled molecular milieu comprising the cellular environment. It is these polymers which determine the protein distribution, functionality, DNA-RNA transcription regulation, and the physical properties of cells.
These polymers create the regulated, homeostatic control in physiologic systems; they are ubiquitously present throughout cellular domains and as such are responsible for the possibilities of molecular reactions of various types.
The normal cellular processes associated with life lead to re-arrangement, altered binding, destruction and change of these polymers. The changes within the polymers lead to changes in protein binding, protein interactions, and transcriptional processes.
The nature of these changes and their locations lead to altered molecular reactions of a non-homeostatic nature which eventuate in processes ultimately recognized as diseases. Where the polymer changes occur in the cellular environments, and the magnitude of these changes determines what type of disease develops.
It is an object of the present invention to provide a treatment which is directed to preventing and minimizing dysfunctional atomic and molecular interactions within human cellular environments and membranes which lead to atherosclerosis and other vascular diseases in which endothelial cells'components and molecules modulate molecular reactions by coadministration of exogenous sources of heparin and arginine and functional analogs or physiologically acceptable salts thereof.
It is another object of the present invention to provide a treatment which is directed to retarding adverse consequences of free radicals generated in human cellular domains by coadministration of exogenous sources of heparin and arginine and functional analogs or physiologically acceptable salts thereof.
It is a further object of the present invention to create an enhanced state of homeostasis within human cellular environments and membranes by coadministration of exogenous sources of heparin and arginine and functional analogs or physiologically acceptable salts thereof.
It is still a further object of the present invention to trigger an auto-regulated endogenous heparin production cycle within human cellular environments and membrane
EndoMatrix, Inc.
Gregory Draper B.
Lanahan & Reilley LLP
Padmanabhan Sreeni
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