Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1998-07-29
2002-01-29
Moezie, F. T. (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S912000
Reexamination Certificate
active
06342477
ABSTRACT:
FIELD OF INVENTION
This invention relates to agents for preventing and treating thrombocytopenia that contain a parathyroid hormone (PTH) or a derivative thereof as an active ingredient.
BACKGROUND OF INVENTION
Platelets, as well as erythrocytes and neutrophils which are also in the class of mature corpuscles, originate from hematopoietic stem cells and are produced by the differentiation and proliferation of these cells. In the early stage of the hematopoietic process, hematopoietic stem cells differentiate and proliferate to megakaryocytes via their precursor cells. Mature magakaryocytes form proplatelets which would eventually be released into peripheral blood as platelets. It has been found that various hematopoietic factors and cytokines are involved in the series of steps in the above-described platelet production process. For example, it has been shown experimentally that interleukin-3 is involved in the stage from stem cells to megakaryocytes, interleukin-6 in the maturing of megakaryocytes and thrombopoietin in the stage from stem cells to the maturing of megakacyocytes. It is speculated that a certain factor is also involved in the process of platelet production and release from mature magakacyocytes but no such factors are yet to be identified.
Thrombocytopenia manifests itself if either one of the steps in the above-described thrombpoletic process is interfered with and there are two major causes of such interference, abnormality in hematopoietic cells and abnormality in hematopoietic factors. In the first case, the differentiation and proliferation of hematopoietic cells are interfered with by either congenital or acquired causes. Aplastic anemia and osteomyelodysplasia syndrome are known to occur by congenital causes and bone marrow transplantation and the administration of chemotherapeutics are two known acquired causes. As for the abnormality in hematopoietic factors, cyclic thrombocytopenia is known to be caused by this reason.
Transfusion of platelets is currently considered to bean effective means of treating thrombocytopenia but this treatment does not necessarily supply an adequate amount of platelets and, in addition, it involves the risk of infection with viruses and other pathogens. Therefore, the development of agents effective in preventing and treating thrombocytopenia is desired.
A parathyroid hormone (PTH) is known as one of the important hormones for bone metabolism. Numerous reports have so far been published to describe the actions of PTH on the bone but there are few reports on its action on the hematopoietic system. The exception is the report by Meytes et al. (J. Clin. Invest. Vol. 67, 1263-1269:1981), which showed that PTH interfered with the in vitro colony formation by BFU-E (precursor cells of erythrocytes) and CFU-GM (precursor cells of granulocytes and macrophages). Thus, nothing has been unravelled about the action of PTH on thrombopoiesis.
SUMMARY OF INVENTION
An object of the present invention is to provide agents for preventing and treating thrombocytopenia. Another object of the invention is to provide pharmaceutical drugs that are effective in treating or preventing diseases that accompany thrombocytopenia.
As the result of their intensive studies, the present inventors found that a parathyroid hormone (PTH) or its derivatives are effective in the treatment of thrombocytopenia, and the present invention has been accomplished on the basis of this finding.
Thus, the present invention relates essentially to an agent for preventing and treating thrombocytopenia that contains a parathyroid hormone (PTH) or a derivative thereof as an active ingredient. The invention also relates to an, agent for preventing and treating thrombocytopenia that contains human PTH(1-84) or one or more derivaties thereof as an active ingredient. The invention further relates to an agent for preventing and treating thrombocytopenia that contains a parathyroid hormone (PTH) or human PTH(1-34) as an active ingredient. The invention also relates to an agent for preventing and treating thrombocytopenia that contains a parathyroid hormone (PTH) as an active ingredient. The invention further relates to an agent for preventing and treating thrombocytopenia that contains human PTH(1-84) as an active ingredient. The invention also relates to an agent for preventing and treating thrombocytopenia that contains a derivative of parathyroid hormone (PTH) as an active ingredient. The invention further relates to an agent for preventing and treating thrombocytopenia that contains human PTH(1-34) as an active ingredient. It should be noted that aside from thrombocytopenia, the agents of the invention for preventing and treating thrombocytopenia are intended to prevent and treat various diseases that are attributable to thrombocytopenia such as thrombocytopenic, purpura and various diseases that tend to cause bleeding due, presumably, thrombocytopenia.
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Brickman et al. “Parathyroid Hormone, Platelet Calcium, and Blood Pressure in Normotensive Subjects”, Hypertension, vol. 18, No. 2, pp. 176-182, Aug. 1991.*
Stedmann's Medical Dictionary, 26th ed., M. Spraycar, editor, Williams & Wilkins, Baltimore. US, 1995.*
Meytes et al., “Effect of Parathyroid Hormone on Erythropoiesis”,J. Clin. Invest., 67:1263-1269, (1981).
Hokom et al., “Pegylated Megakaryocyte Growth and Development Factor Abrogates the Lethal Thrombocytopenia Associated with Carbonplatin and Irradiation in Mice”,Blood, 86: No. 12 4486-4492, (1995).
Herodin et al., “Recombinant Glycosylated Human Interleuin-6 Accelerated Peripheral Blood Platelet Court Recovery in Radiation-Induced Bone Marrow Depression in Baboons”,Blood, 80: No. 3 688-695, (1992).
Wallace et al., “Thrombocytopoietic Properties of Oncostatin M”,Blood, 86: No. 4 1310-1315, (1995).
Leonard et al., “Recombinant Human Interleukin-11 Stimulates Multilineage Hematopoietic Recovery in Mice After a Myelosuppressive Regimen of Sublethal Irradiation and Cardonplatin”,Blood, 83: No. 6 1499-1506, (1994).
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Oda Yasuhiro
Tamura Masahiko
Chugai Seiyaku Kabushiki Kaisha
Moezie F. T.
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