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(12) United States Patent (10) Patent No.: US 6,852,700 B1 Janusz Et Al

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(12) United States Patent (10) Patent No.: US 6,852,700 B1 Janusz Et Al USOO68527OOB1 (12) United States Patent (10) Patent No.: US 6,852,700 B1 JanuSZ et al. (45) Date of Patent: Feb. 8, 2005 (54) COLOSTRININ, AND USES THEREOF Burrin, “Nutrient-independent and nutrient-dependent fac tors Stimulate protein Synthesis in coloStrum-fed newborn (75) Inventors: Marin Janusz, Wroclaw (PL); Jozef pigs' 1995, Pediatric Research, vol. 37, pp-593–599.* Lisowski, Wroclaw (PL); Anna Staroscik et al, Molecular Immunology, vol. 30, No. 12, pp. Dubowska-Inglot, deceased, late of 1277-1282, 1983.* Wroclaw (PL); by Mieczyslaw Inglot, Haraba et al, Arch. Immun. Ther. Exp. 1986, pp. 437-443.* legal representative, Wroclaw (PL) Zimecki, Arch. Immun Ther. Exp. 1991, pp. 461–467.* (73) Assignee: Ludwig Hirzfeld Institute of Janusz et al., Arch. Immun. Ther. Exp., 1993, pp. 175-279.* Immunology and Experimental Janusz et al., Isolation And Characterization Of A Poli Therapy, Polish Academy of Sciences, ne-Rich Polypeptide From Ovine Colostrum, FEBS Letters, Warsaw (PL) vol. 49, No. 2, Dec. 1974, pp. 276-279. JanuSZ et al., “Chemical and physical characterization of a (*) Notice: Subject to any disclaimer, the term of this proline-rich polypeptide from sheep colostrum.” The Bio patent is extended or adjusted under 35 chemical Journal, vol. 1999, pp. 9-15, 1981. U.S.C. 154(b) by 0 days. Staroscik et al., “Immunologically Active Nonpeptide Frag ment Of A Proline-Rich Polypeptide From Ovine Colos (21) Appl. No.: 09/269,845 trum: Amino Acid Sequence And Immunoregulatory Prop (22) PCT Filed: Oct. 3, 1997 erties,” Molecular Immunology, vol. 30., No. 12, pp. 1277-1282, 1983. (86) PCT No.: PCT/GB97/02721 Japanese Patent Abstract, Application No. 01085119, Pub S371 (c)(1), lication No. 02265458, Publication Date Oct. 30, 1990. (2), (4) Date: Sep. 24, 1999 Hraba et al., “Effect of Proline-Rich Polypeptide on Experi mental Autoimmune Response to Erythrocytes, Archivum (87) PCT Pub. No.: WO98/14473 Immunolgiae et Therapiae Experimentalis, 1986, pp. PCT Pub. Date:Apr 9, 1998 437-443. Zimecki et al., “Effect of a Proline-Rich Polypeptide (PRP) (30) Foreign Application Priority Data on the Development of Hemolytic Anemia and Survival of Oct. 3, 1996 (PL) ................................................ 316416 New Zealand Black (NZB) Mice.” Archivum Immunologiae et Therapiae Experimentalis, 1991, pp. 461–467. (51) Int. Cl. ................................................ A61K 31/70 Unlisted Drugs, Mar. 1989, vol. 41, No. 3, p. 52. (52) U.S. Cl. ............................... 514/21; 514/2; 514/12; Janusz et al., “Proline-Rich Polypeptide (PRP)-an Immu 514/15; 530/300; 530/328; 530/350 nomodulatory Peptide from Ovine Colostrum.” Archivum (58) Field of Search ................................ 514/2, 12, 15, Immunologiae et Therapiae Experimentalis, 1993, pp. 514/21; 530/300, 328, 350 175-279. (56) References Cited Inglot et al., “Colostrinine: a Proline-Rich Polypeptide from Ovine Colostrum Is a Modest Cytokine Inducer in Human U.S. PATENT DOCUMENTS Leukocytes, Archivum Immunologiae et Therapiae Experi 5,710,132 A 1/1998 Moller et al. mentalis, 1996, pp. 215-223. Abstract entitled “Colostrinin For Treatment Of Alzheimer's FOREIGN PATENT DOCUMENTS Disease,” European Cytokine Network vol. 7, No. 3-Esti DE 9743905 11/1997 mated Publication Oct. 4, 1996. GB 2289278 11/1995 GB 9814473 4/1998 * cited by examiner HU 208O89 B 4/1989 WO 97.05884 2/1997 Primary Examiner-Christopher Tate Assistant Examiner Roy Teller OTHER PUBLICATIONS (74) Attorney, Agent, or Firm-Rankin, Hill, Porter & Clark LLP Kruzel, Journal of Molecular Neuroscience, 2001, 17, pp. 379-389.* (57) ABSTRACT Inglot, Archivum Immunologiae et Therapiae Experimenta lis, 1996, 44, pp. 215-224.* The use of ColoStrinin as a medicament, particularly in the JanuSZ, Archivum Immunologiae et Therapiae Experimen treatment of chronic disorders of the central nervous System talis, 1993, 41, pp. 275-279.* and the immune System. Inglot et al., Archivum Immun. et Ther. Exper, vol. 44, 1996, pp. 215-224.* 32 Claims, No Drawings US 6,852,700 B1 1 2 COLOSTRININ, AND USES THEREOF chiatric patients in a State of depression-the use of Colos trinin has been found to help the patient with an improve This application is the U.S. National Phase of PCT/ ment in feelings of wellbeing and with mood Stabilisation. GB97/02721 filed Oct. 3, 1997. The Colostrinin may also be used as an auxiliary withdrawal The present invention relates to Colostrinin, and to its use treatment for drug addicts, after a period of detoxification, as a medicament. and in perSons dependent on Stimulants. Colostrum is the thick, yellowish fluid produced by a In another advantageous embodiment of the invention, the Colostrinin is for use in the treatment of disorders of the mammalian mother's breasts during the first few days after immune System, particularly chronic disorders of the childbirth. It is replaced by mature breast milk about four to immune System. Thus, we have found that ColoStrinin can five days after birth. Compared with mature breast milk, be used in the treatment of disease requiring immunomodu colostrum contains low Sugar. However, colostrum is richer lation. In particular, we have found that ColoStrinin is useful in lipids, protein, mineral Salts, Vitamins and immuno for treating Such disorders in non-rodent animals, including globulin. It also contains various floating cells Such as humans. ColoStrinin is useful in the treatment of a variety of granular and Stromal cells, neutrophils, monocyte/ diseases with an immunological and infectious basis. For macrophages and lymphocytes and includes growth factors, 15 example, the Colostrinin can be used to treat chronic dis hormones and cytokines. eases with a bacterial and Viral aetiology, and to treat Various factors have been isolated and characterised acquired immunological deficiencies that have developed, from mammalian colostrum. In 1974, Janusz et al (FEBS for example, after chemotherapy or radiotherapy of neo Lett., 49, 276-279) isolated a proline-rich polypeptide plasms. The invention is particularly useful for treating (PRP) from Ovine colostrum. The contents of this reference chronic bacterial and viral infections requiring non-specific are incorporated herein by reference. It has since been immunostimulation and immunocorrection. discovered that mammals other than sheep have analogues In general, a chronic disorder is a disorder that has of PRP as a component of their colostrum. PRP has since persisted for a long time, usually at least one week, more been called Colostrinin and is tentatively identified as a new usually at least one month, and often at least 3 months or at class of cytokine. 25 least 6 months. Janusz et all in “Proline-Rich Polypeptide (PRP)-an It is a feature of the present invention to use ColoStrinin Immunomodulatory Peptide from Ovine Colostrum’ for improving the development of the immune System of a (Archivum Immunologiae et Therapiae Experimentalis, new born child. It is a further feature of the invention to use 1993, 41, 275-279) mentioned that PRP from ovine colos Colostrinin to correct immunological deficiencies in a child. trum has immunotropic activity in mice. However, there was These uses of the Colostrinin may be particularly applicable no suggestion in this document that the PRP would have any to babies or children who have been deprived of colostrum. therapeutic effect on any other animal. It will be appreciated This may occur, for example, in babies and children who that the fact that a composition has a therapeutic effect on were not breast fed from birth; the artificial feed that Such mice cannot be taken to Suggest that there will be a thera babies and children would have been given does not contain peutic effect on any other animal. 35 Colostrinin. We have now found that Colostrinin has a number of According to another aspect of the invention, we provide previously unknown therapeutic effects. More particularly, the use of ColoStrinin as a dietary Supplement. Colostrinin is we have found that ColoStrinin provides an immunotropic particularly advantageously used as a dietary Supplement for action and provides a psychotropic action. babies and young children to correct deficiencies in the According to one aspect of the invention we provide 40 development of their immune System. AS noted above, Such Colostrinin for use as a medicament. The Colostrinin may be deficiencies would arise in babies and children who had not used as a medicament for non-rodent mammals, we have been breast fed from birth. The Colostrinin may also be used found that ColoStrinin is especially useful as a medicament as a dietary Supplement for adults who have been Subjected for the treatment of humans. to chemotherapy, or have Suffered from cahexia, or weight According to another aspect of the invention there is 45 loSS due to chronic disease. In an aspect of the invention, we provided the use of Colostrinin in the manufacture of a provide a dietary Supplement comprising an orally ingestible medicament for treating disorders of the central nervous combination of Colostrinin in combination with a physi System or disorders of the immune System. ologically acceptable carrier. The dietary Supplement may In one advantageous embodiment of the invention, the be provided in liquid or Solid form; the dietary Supplement Colostrinin is for use in the treatment of disorders of the 50 may suitably be provided in the form of a tablet. central nervous System, particularly chronic disorders of the In accordance with the invention, the Colostrinin may be central nervous System. The disorders of the central nervous administered prophylactically in order to help to prevent the System that may be treated with ColoStrinin include neuro development of disorders of the central nervous System and logical disorders and mental disorders. the immune System. Examples of neurological disorders that can, with 55 The Colostrinin used in the aspects of the invention advantage, be treated by ColoStrinin include dementia, and described above may be ovine Colostrinin, or it may be also disorders that cause dementia, Such as neurodegenera non-ovine Colostrinin.
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