Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2001-01-16
2004-09-07
Tate, Christopher (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C514S014800, C530S300000, C530S311000, C530S324000, C424S185100
Reexamination Certificate
active
06787521
ABSTRACT:
BACKGROUND OF THE INVENTION
Tissue comprises organized cellular groups that are attached to an extracellular matrix and are surrounded by a network of blood vessels. Fibrosis is an abnormal accumulation of a collagen matrix following injury or inflammation which alters the structure and function of various tissues. Irrespective of location, the major pathology of fibrosis involves an excessive deposition of a collagen matrix which replaces the normal tissue at that site. Progressive fibrosis in the kidney, liver, lung, heart, bone or bone marrow, and skin is a major cause of death and suffering. See, e.g., Border, et al., New Engl. J. Med. 331:1286 (1994).
Development of fibrosis has been linked to the overexpression and over-production of TGF-&bgr; in numerous tissues and fibrotic disease states (see Border et al., N Engl J Med 1994, pp. 1286-92).
SUMMARY OF THE INVENTION
The present Invention relates to a method of treating fibrosis in a patient (e.g., a mammal such as a human). The method includes the step of administering a therapeutically effective amount of somatostatin or a somatostatin agonist to said patient. The somatostatin or somatostatin agonist may be administered orally, topically, parenterally, e.g., administered intravenously, subcutaneously, or by implantation of a sustained release formulation. Fibrosis is the abnormal accumulation of an extracellular matrix (e.g., collagen) in tissue. The fibrosis, for example, may be located: in the kidney, for example, fibrosis as observed in glomerulonenephritis, diabetic nephropathy), allograft rejection, and HIV nephropathy; in the liver, for example, cirrhosis, and veno-occlusive disease; in the lung, for example, idiopathic fibrosis; in the skin, for example, systemic sclerosis, keloids, scars, and eosinophilia-myalgia syndrome; in the central nervous system, for example, intraocular fibrosis; in the cardiovascular system, for example, vascular restenosis; in the nose, for example, nasal polyposis; in bone or bone marrow; in an endocrine organ; and in the gastrointestinal system.
A fibrotic disorder may be induced by a number of causes including: chemotherapy, for example pulmonary fibrosis resulting from bleomycin, chlorambucil, cyclophsphamide, methotrexate, mustine, or procarbazine treatment; radiation exposure whether accidental or purposeful as in radiation therapy, for example, interstitial lung disease (ILD) resulting from radiation; environmental or industrial factors or pollutants such as chemicals, fumes, metals, vapors, gases, etc. (e.g. ILD resulting from asbestos or coal dust); a drug or combination of drugs, for example, antibiotics (e.g. penicillins, sulfonamides, etc.), cardiovascular drugs (e.g. hydralazine, beta blockers, etc.), CNS drugs (phenytoin, chlorpromazine, etc.) anti-inflammatory drugs (e.g. gold salts, phenylbutazone, etc.), etc. can cause ILD; an immune reaction disorder, for example, chronic graft-vs-host disease with dermal fibrosis); disease states (e.g., aspiration pneumonia which is a known cause of ILD) which include parasite induced fibrosis; and wounds, for example, blunt trauma, surgical incisions, battlefield wounds, etc., as in penetrating injuries of the CNS.
In one aspect, this invention provides a method of inhibiting fibrosis in a patient, said method comprising administering a therapeutically effective amount of somatostatin or a somatostatin agonist to said patient; a method which is preferred of the foregoing method is wherein said method comprises administering a therapeutically effective amount of a somatostatin agonist to said patient.
In another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis which is inhibited is in the:
kidney wherein the fibrotic disorder inhibited in the kidney is preferably glomerulonephritis, diabetic nephropathy, allograft rejection or HIV nephropathy,
lung wherein the fibrotic disorder inhibited in the lung is preferably idiopathic fibrosis or autoimmune fibrosis,
liver wherein the fibrotic disorder inhibited in the liver is preferably cirrhosis or veno-occlusive disease,
skin wherein the fibrotic disorder inhibited in the skin is preferably systemic sclerosis, keloids, scars or eosinophilia-myalgia syndrome,
central nervous system wherein the fibrotic disorder inhibited in the central nervous system is preferably intraocular fibrosis,
bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by chemotherapy and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by radiation and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by a drug or combination of drugs and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by a disease state and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by an environmental or industrial factor and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by an immune response by the patient and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately foregoing methods is preferred.
In yet another aspect, this invention provides a method of inhibiting fibrosis in a patient which comprises administering to the patient a therapeutically effective amount of a somatostatin agonist wherein the fibrosis is induced by a wound and preferably the fibrosis inhibited is in the kidney, lung, liver, skin, central nervous system, bone or bone marrow, cardiovascular system, an endocrine organ or gastrointestinal system. Each of the immediately fore
Culler Michael D.
Kasprzyk Philip G.
Feeney Alan F.
Fish & Richardson
Morrill Brian R.
Societe de Conseils de Recherches et d'Applications Scienti
Tate Christopher
LandOfFree
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