Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-02-12
2003-07-29
Saoud, Christine J. (Department: 1647)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C530S399000
Reexamination Certificate
active
06599879
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the administration of Keratinocyte Growth Factor-2 (KGF-2) to increase levels of platelets, fibrinogen, albumin, globulin and total serum protein. Further, the present invention relates to administering KGF-2 to protect or treat the bladder and prostate. Moreover, the present invention relates to administering KGF-2 to stimulate growth of nasal, oral, and esophageal mucosa, lacrimal glands, salivary glands and Goblet cells.
BACKGROUND OF THE INVENTION
Thrombocytopenia is a condition in which there is an abnormally small number of platelets in the circulating blood (Stedman's Medical Dictionary, 26th edition, Marjory Spraycar, Editor (1995). Thrombocytopenia results from various causes, but ultimately occurs when platelets are destroyed, sequestered in the body, or not produced. The differential diagnosis of thrombocytopenia is extensive and complex, and there is a significant overlap among disorders (Doyle B, and Porter D. L. A.A.C.N. Clin. Issues 8: 469-480 (1997).
Thrombocytopenia may be caused by a variety of mechanisms including, but not limited to, drug induced hypersensitivity, idiopathic thrombocytopenia purpura (ITP), posttransfusion purpura, neonatal thrombocytopenia, bone marrow deficiencies identified with metastatic tumors to the bone, aplastic anemia, myelofibrosis, acute and monocytic leukemia, microangiopathic hemolytic anemia which includes disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), hemolytic-uremic syndrome, prosthetic valve hemolytic syndrome, cancer chemotherapy, Zieve's syndrome, sepsis, HELLP preclamptic syndrome, megaloblastic anemia due to B21 and folic acid deficiency, infections such as peritonitis (without septicemia), congenital rubella syndrome, HIV-1 virus infections, Epstein-Barr infectious mononucleosis, rheumatoid-collagen diseases such as systemic lupus, hypertension of pregnancy associated with preclampsias, thyrotoxicosis and uremia (
Clinical guide to laboratory tests.
(3rd ed). Philadelphia, W.B. Saunders Company, 1995;
Clinical Laboratory Medicine. Clinical application oflaboratory data.
(6th ed.) St. Louis, Mosby, 1995).
Fibrinogen is an abundant plasma glycoprotein that is synthesized in the liver. Thrombin sequentially cleaves fibrinopeptides A and B from the &agr; and &bgr; chains of fibrinogen to produce fibrin monomer, which then polymerizes to form a fibrin clot which is the final major step in the coagulation process. Mutations have been identified which alter the release of fibrinopeptides from the &agr; and &bgr; chains of fibrinogen, the rate of polymerization of fibrin monomers, and the sites for fibrin cross-linking. This mutations lead to dysfibrinogenemias which are almost always inherited as autosomal dominant traits. Patients with afibrinogenemia, who have no detectable fibrinogen in plasma or platelets, may have infrequent, mild spontaneous bleeding episodes. (Harrison's Principles of Internal Medicine 11th edition Eugene Braunwald et. al., Editors (1987)).
Hypofibrinogenemia refers to a condition in which there is an abnormally low concentration of fibrinogen in the circulating blood plasma (Stedman's Medical Dictionary, 26th edition, Marjory Spraycar, Editor (1995)). Hypofibrinogenemia may be caused by a variety of conditions or afflictions including, but not limited to, abnormal hepatic synthesis such as that associated with acute hepatitis or cirrhosis, and disseminated intravascular coagulation (DIC).
Albumin, the major serum protein, is considered to be responsible for maintenance of normal serum colloid osmotic pressure, transport of certain hormones and maintaining an endogenous source of amino acids (Buehler, B. A. Ann. Clin. Lab. Sci. 8: 283-286 (1978)). Hypoalbuminemia is a condition in which there is an abnormally low concentration of albumin in the circulating blood. The serum albumin level is one of several clinical parameters of the status of general health. There is a marked correlation between low albumin levels and the incidence of morbidity and mortality in hospitalized patients. Therefore, it is not surprising to find that hypoalbuminemia is a common finding among hospitalized patients. Hypoalbuminemia is known to be associated with delayed wound healing. The hypoalbuminemic state interferes with the normal functioning of the gastrointestinal tract. Qualitative changes in the albumin molecule which occur in renal disease may damage the nephron. Low serum albumin levels may adversely affect the coagulation system (Doweiko, J. P., and Nompleggi, D. J. J.P.E.N. J. Parenter. Enteral. Nutr. 15: 476-483 (1991)).
Hypoalbuminemia can be caused by a variety of afflictions or conditions including, but not limited to, hemorrhages, bums, exudates, rheumatic diseases, granulomatous processes, most bacterial infections, viral infections accompanied by tissue destruction, tissue necrosis, vasculitis, ulcerative bowel disease, serositis, subacute bacterial endocarditis, parasitic infestations, acute and chronic liver disease, amyloidosis, malnutrition, malignancy, congestive heart failure, constrictive pericarditis, cardiac valvular disease, nephrotic syndrome, trauma and crush injuries, gastrointestinal and lymphatic fistulae, and protein-losing gastroenteropathies (
Clinical guide to laboratory tests.
(3rd ed). Philadelphia, W.B. Saunders Company, 1995;
Clinical Laboratory Medicine. Clinical application of laboratory data.
(6th ed.) St. Louis, Mosby, 1995).
Globulin is the name for a family of proteins precipitated from plasma or serum by half-saturation with ammonium sulphate. Globulins may be fractionated by solubility, electrophoresis, ultracentrifugation, and other separation methods into many subgroups, the main subgroups being &agr;-, &bgr;-, and &ggr;-globulins. These differ with respect to associated lipids or carbohydrates and in their content of many physiologically important factors. Globulins include immunoglobulins in the &bgr;, and &ggr; fractions, lipoproteins in the &agr; and &bgr; fractions, gluco- or mucoproteins (orosomucoid, haptoglobulin), and metal binding and metal transporting proteins (such as transferrin, siderophilin, ceruloplasmin). Other substances found in globulin fractions are: macroglobulin, plasminogen, prothrombin, euglobulin, antihemophilic globulin, fibrinogen, and cryoglobulin (Stedman's Medical Dictionary, 26th edition, Marjory Spraycar, Editor (1995)).
Certain reasonably predictable changes take place in plasma protein levels in response to acute illness. Hypoglobulinemia refers to an abnormally low concentration of globulin in the circulating plasma. Hypoglobulinemia may result from a variety of conditions or afflictions including, but not limited to, alpha-1 antityrpsin deficiencies, severe liver disease, estrogen therapy, megaloblastic anemia, hypogammaglobulinemia and aggammaglobulinemia (
Clinical guide to laboratory tests.
(3rd ed). Philadelphia, W.B. Saunders Company, 1995;
Clinical Laboratory Medicine. Clinical application of laboratory data.
(6th ed.) St. Louis, Mosby, 1995).
A decrease in total serum protein is associated with protein loss (protein-losing gastroenteropathies, acute burns, nephrotic syndrome) and decreased synthesis of protein (chronic liver disease, malabsorption syndrome, malnutrition, and agammaglobulinemia).
Hemorrhagic cystitis is a syndrome associated with certain disease states as well as exposure to drugs, viruses, and toxins. It manifests as diffuse bleeding of the endothelial lining of the bladder. Treatment includes intravesical, systemic, and nonpharmacologic therapies (West, N. J. Pharmacotherapy 17: 696-706 (1997)).
Loss of the ability to produce adequate amounts of saliva and tears is a major clinical problem affecting millions of people and there are few therapeutic options for these sufferers. Patients with xerostomia, or dry mouth, have difficulty swallowing, have painful cracks in their mouths, and experience a decrease in their ability to taste. This condition may be caused by Sjogren's syndr
Jimenez Pablo
Louie Arthur
Mendrick Donna
Rampy Mark A.
Russell Deborah
Human Genome Sciences Inc.
Human Genome Sciences Inc.
Saoud Christine J.
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