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Ep001223941b1* (19) *EP001223941B1* (11) EP 1 223 941 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/565 (2006.01) A61K 31/566 (2006.01) 05.11.2008 Bulletin 2008/45 A61P 7/06 (2006.01) (21) Application number: 00970511.2 (86) International application number: PCT/US2000/026771 (22) Date of filing: 28.09.2000 (87) International publication number: WO 2001/030802 (03.05.2001 Gazette 2001/18) (54) THERAPEUTIC TREATMENTS FOR BLOOD CELL DEFICIENCIES USING SREROIDS THERAPEUTISCHE VERWENDUNGEN VON STEROIDEN BEI BLUTZELLMANGELZUSTAENDEN TRAITEMENTS THERAPEUTIQUES POUR DES DEFICIENCES EN CELLULES SANGUINES PAR DES STEROIDES (84) Designated Contracting States: • SINGER J W ET AL: "STEROIDS AND AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU HEMATOPOIESIS PART 1 THE EFFECT OF MC NL PT SE STEROIDS ON IN-VITRO ERYTHROID COLONY GROWTH STRUCTURE ACTIVITY (30) Priority: 25.10.1999 US 161453 P RELATIONSHIPS" JOURNAL OF CELLULAR PHYSIOLOGY, vol. 88, no. 2, 1976, pages 127-134, (43) Date of publication of application: XP001015349 ISSN: 0021-9541 24.07.2002 Bulletin 2002/30 • LAFAYE, PIERRE ET AL: "The 7.alpha.-hydroxysteroids produced in human (73) Proprietor: Hollis-Eden Pharmaceuticals Inc. tonsils enhance the immune response to tetanus San Diego, CA 92121 (US) toxoid and Bordetella pertussis antigens" BIOCHIM. BIOPHYS. ACTA (1999), 1472(1-2), (72) Inventors: 222-231 , XP001014347 • FRINCKE, James, Martin • DATABASE BIOSIS [Online] BIOSCIENCES San Diego, CA 92192 (US) INFORMATION SERVICE, PHILADELPHIA, PA, • READING, Christopher, L. US; 1983 FEDOROVSKAYA N A ET AL: San Diego, CA 92112-3511 (US) "CHARACTERISTICS OF IMMUNO • PRENDERGAST, Patrick, T. HEMATOLOGIC PARAMETERS IN PATIENTS County Kildare (IE) WITH HYPOPLASTIC ANEMIA DURING REMISSION" Database accession no. (74) Representative: Kaiser, Jürgen et al PREV198477064932 XP002174053 & Winter, Brandl, Fürniss, Hübner, GEMATOLOGIYA I TRANSFUZIOLOGIYA, vol. 28, Röss, Kaiser, Polte no. 7, 1983, pages 29-32, ISSN: 0234-5730 Partnerschaft • PIERELLI LUCA ET AL: "Erythropoietin addition Patent- und Rechtsanwaltskanzlei to granulocyte colony-stimulating factor Alois-Steinecker-Strasse 22 abrogates life-threatening neutropenia and 85354 Freising (DE) increases peripheral-blood progenitor-cell mobilization after epirubicin, paclitaxel, and (56) References cited: cisplatin combination chemotherapy: Results of WO-A-97/13500 WO-A-97/17992 a randomized comparison." JOURNAL OF US-A- 4 602 008 US-A- 5 763 433 CLINICAL ONCOLOGY, vol. 17, no. 4, April 1999 (1999-04), pages 1288-1295, XP001015368 ISSN: 0732-183X Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 223 941 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 1 223 941 B1 • ALONZI TONINO ET AL: "Interleukin-6 and CAAT/ Remarks: enhancer binding protein beta-deficient mice act Thefilecontainstechnicalinformationsubmittedafter as tools to dissect the IL-6 signalling pathway and the application was filed and not included in this IL-6 regulation." IMMUNOBIOLOGY, vol. 198, no. specification 1-3, December 1997 (1997-12), pages 144-156, XP001015352 ISSN: 0171-2985 2 EP 1 223 941 B1 Description FIELD OF THE INVENTION 5 [0001] The present invention relates to a use of a compound for the preparation of a medicament for the prophylaxis or treatment of neutropenia and thrombocytopenia in a human or primate subject, in accordance with claim 1. BACKGROUND OF THE INVENTION 10 [0002] Hemopoiesis is the formation and development of the various types of blood cells and their progenitor cells. Mature cells are found in circulation or tissues such as the lymph nodes or the thymus. Many of the stem cells that give rise to mature forms reside in the bone marrow, although some may circulate in the blood for some time. Clinical blood cell deficiencies such as thrombocytopenia, neutropenia or erythropenia can arise from causes such as impaired he- mopoiesis or abnormal loss or destruction of mature or immature blood cells. 15 [0003] Thrombocytopenia ("TP"), abnormally low platelet counts, can arise from impaired platelet production, seques- tration of platelets in the spleen or abnormal loss of circulating platelets. Impaired production can result from causes such as chemotherapies or radiation therapies. Abnormal loss of circulating platelets is often associated with autoreactive antibodies that bind to platelets and reduce their life span. These underlying causes give rise to the various clinical forms of TP, such as autoimmune neonatal TP, immune thrombocytopenic purpra, radiation induced TP, chemotherapy induced 20 TP and amegakaryocitic TP. [0004] A number of treatment options are available and the selection of a treatment typically depends on the source of the disorder and its severity. Treatments include administering one or more of glucocorticoid steroids (e.g., prednisone, prednisolone), human IgG antibodies, anti-Rh(D)+ antibodies for Rh(D)+ patients, an androgen such as danazol, vinca alkaloids (e.g., vincristine, vinblastine), thrombopoietin and immunosuppresants (e.g., azathioprine, cyclophosphamide). 25 Splenectomy is also indicated, for example when first line treatments fail. The goal of treatment is typically to increase platelet counts to 20,000 mm-3 or more typically to at least about 50,000 mm-3 and to maintain these levels. [0005] Although the treatment options to increase platelet levels are generally known, they usually have a number of drawbacks. For example, infusion of IgG antibodies is not always effective and the treatment is relatively expensive. Other treatments, such as prednisone are also not always effective and they typically are discontinued or tapered off 30 after several weeks due to toxicity. Splenectomy, which is relatively expensive and invasive, is also not always effective. [0006] The sources of thrombocytopenia and treatment options have been described. See, e.g., Hematology - Basic Principles and Practice, 3rd edition, R. Hoffman, E.J. Benz Jr. et al., editors, Churchill Livingstone, New York, 2000 (see, e.g., Chapters 126-129 and 131 at pages 2096-2154 and 2172-2186), PCT publication WO 200035466. [0007] Neutropenia ("NP"), is considered to exist clinically when neutrophils drop to below a level considered normal. 35 NP can arise from impaired production of neutrophil precursors or mature neutrophils, movement of neutrophils from the circulation to tissue, abnormal circulating neutrophil loss or a combination of these causes. Impaired neutrophil production can be acquired from, e.g., treatment with a cytotoxic or cytostatic drug, chemotherapy, radiation therapy or an autoimmune response. The abnormal loss of circulating neutrophils in autoimmunity is associated with autoreactive antibodies that bind to the cells and reduce their life span. These underlying causes give rise to the various clinical forms 40 of NP, such as postinfectious NP, drug-induced NP, autoimmune NP, or chronic idiopathic NP. [0008] The sources of NP and treatment options have been described. See, e.g., Hematology - Basic Principles and Practice, 3rd edition, R. Hoffman, E.J. Benz Jr. et al., editors, Churchill Livingstone, New York, 2000 (see, e.g., Chapters 19, 41, 51, 79, 134 and 137 at pages 297-331, 720-762, 939-979, 1443-1500, 2220-2248 and 2257-2263). [0009] The use of 3β-hydroxyandrost-5-ene-17-one, 3β,17β-dihydroxyandrost-5-ene and other steroids to modulate 45 immune functions or to stimulate myelopoiesis has been described, see, e.g., M.H. Whitnall et al., Int’l. J. Immunophar- macology 2000 22:1-14. U.S. patents 5,162,198, 5,206,008, 5,292,730, 5,407,684, 5,461,042, 5,461,768, 5,478,566, 5,585,371, 5,635,496, 5,641,766, 5,753,237, 5,837,269, 5,885,977 and 5,919,465, PCT publication nos. WO93/20696 and WO99/25333. I. Porsova-Dutoit et al., Physiological Res. 2000 49(Suppl. 1):S43-S56, R.L. Jesse et al., Ann. N. Y. Acad. Sci. 1995 774:281-290 and U.S. patent 5,532,230, 5,811,418 and 5,846,963 discuss the capacity of 3β-hydrox- 50 yandrost-5-ene-17-one, its 3-sulfate derivative and other steroids to affect platelet and neutrophil aggregation or their adhesion to endothelial cells. [0010] U.S. patents 4,908,358 and 4,902,681 describe the capacity of compounds such as 5α-pregnan-3,20-dione, cortexolone, 17-hydroxyprogesterone and 16α-methylprogesterone to inhibit the clearance of antibody-coated cells from circulation in disorders such as immune thrombocytopenic purpura or immune hemolytic anemia. 55 [0011] U.S. patents 5,532,230, 5,686,438, 5,753,640 and 5,811,418 and J. Bratt and M. Heimburger, Scand. J. Rheu- matol. 1999 28:308-313 describe the capacity of compounds such as 3β,7β-dihydroxyandrost-5-ene-17-one, prednisolo- ne, and 3β-hydroxyandrost-5-ene-17-one to limit tissue damage in ischemic tissues by inhibiting adhesion of cells such as neutrophils to endothelial cells or to treat pulmonary hypertension. 3 EP 1 223 941 B1 [0012] U.S. patent 5,859,000 describes the capacity of compounds such as 3β,7β-dihydroxyandrost-5-ene-17-one and 3β-hydroxyandrost-5-ene-17-one to reduce mast cell mediated allergic reactions. [0013] U.S. patent 5,763,433 and PCT publication WO 96/35428 describe the capacity of compounds related to dehydroepiandrosterone and 16α-halodehydroepiandrosterone to modulate immune responses and to treat conditions 5 certain immune related conditions such as systemic lupus erythematosus. [0014] U.S. patents 5,925,630, 5,939,545 and 5,962,443 describe the capacity of 19-nur-pregnane steroids, 3α- hydroxy-5a-pregnan-20-one and related steroids to modulate certain neurological activities such as hypothalamic func- tion and GABA receptor activity.
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