Method of diagnosis and treatment and agents useful for same
| Title: | Method of diagnosis and treatment and agents useful for same |
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| Patent Number: | 7,700,271 |
| Publication Date: | April 20, 2010 |
| Appl. No: | 10/799797 |
| Application Filed: | March 12, 2004 |
| Abstract: | The present invention relates generally to a method for detecting an aberrant cell, and more particularly an aberrant epithelial cell, in a subject or in a biological sample from said subject and agents useful for same. More particularly, the present invention relates to a method of deleting an aberrant mammary epithelial cell. The presence of the aberrant cell or group of aberrant cells provides an indication of a particular disease or condition or a propensity for development of a disease or condition. |
| Inventors: | Visvader, Jane Ellen (Kew, AU); Lindeman, Geoffrey John (Kew, AU); Sum, Eleanor Y. M. (Preston, AU); O'Reilly, Lorraine Ann (Cheltenham, AU) |
| Assignees: | The Walter and Eliza Hall Institute of Medical Research (Victoria, AU) |
| Claim: | 1. A method for detecting an aberrant mammary epithelial cell in a subject or in a biological sample from said subject, said method comprising contacting cells or cell extracts from said subject or said biological sample with an antibody specific for LIM domain only 4 (LMO4), screening for the level of antibody-LMO4 complex formation, comparing the level of the LMO4-antibody complex in the cells from said subject or said sample with the level of the LMO4-antibody complex in normal cells, and determining the presence of an aberrant mammary epithelial cell based on an elevated level of the LMO4-antibody complex in the cells from said subject or said sample relative to normal mammary epithelial cells. |
| Claim: | 2. A method for diagnosing the presence of breast cancer in a subject, said method comprising contacting cells or cell extracts from said subject or a biological sample from said subject with a LMO4-binding effective amount of an antibody having specificity for said LMO4, quantitatively or qualitatively determining the level of a LMO4-antibody complex, comparing the level of the LMO4-antibody complex in the cells from said subject or said sample with the level of the LMO4-antibody complex in normal cells, and determining the presence of breast cancer based on an elevated level of the LMO4-antibody complex in the cells from said subject or said sample relative to normal cells. |
| Claim: | 3. The method according to claim 1 wherein said antibody is selected from: (i) a deimmunized antibody molecule having specificity for an epitope recognized by a monoclonal antibody specific for LMO4 wherein said antibody is deimmunized with respect to the host into which it will be introduced; (ii) an isolated monoclonal antibody wherein said antibody interacts with LMO4; (iii) the monoclonal antibody secreted by hybridoma 16H2 (ECACC Accession No. 03052001); (iv) the monoclonal antibody secreted by hybridoma 20F8 (ECACC Accession No. 03052002). |
| Claim: | 4. A method of detecting, LMO4 in a sample, comprising contacting the sample with an antibody or a fragment thereof specific for LMO4, detecting the level of a complex comprising said antibody or said fragment and LMO4, and comparing the level of said complex in said sample with the level of complex in normal controls and determining an indication of breast cancer growth based on an elevated level of the complex in said sample relative to said normal controls. |
| Claim: | 5. The method according to claim 4 wherein said antibody is selected from: (i) a deimmunized antibody molecule having specificity for an epitope recognized by a mono clonal antibody specific for LMO4 wherein said antibody is deimmunized with respect to the host into which said antibody will be introduced; (ii) an isolated monoclonal antibody wherein said antibody interacts with LMO4; (iii) the monoclonal antibody secreted by hybridoma 16H2 (ECACC Accession No. 03052001); (iv) the monoclonal antibody secreted by hybridoma 20F8 (ECACC Accession No. 03052002). |
| Claim: | 6. A method for detecting an aberrant mammary epithelial cell in a subject or in a biological sample from said subject, said method comprising contacting cells or cell extracts from said subject or said biological sample with an antibody or fragment thereof specific for LMO4, and detecting an elevated level of LMO4 relative to a normal cell as indicative of an aberrant mammary epithelial cell. |
| Current U.S. Class: | 435/4 |
| Patent References Cited: | 2003/0092009 May 2003 Palm 2006/0148008 July 2006 Hart et al. WO 00/29852 May 2000 WO 01/38878 May 2001 WO 02/40716 May 2002 WO 2004/073739 September 2004 |
| Other References: | W. Paul, Fundamental Immunology, 3rd Edition, 1993. cited by examiner Rudikoff et al., Proc. Natl. Acad. Sci. USA 1982 vol. 79: p. 1979. cited by examiner Visvader et al., PNAS, vol. 98, p. 14452-14457, Dec. 2001. cited by examiner Burgess et al, Journal of Cell biology, vol. 111, p. 2129-2138, 1990. cited by examiner Kenny et al., PNAS, vol. 95, p. 11257-11262, 1998 (IDS, Feb. 4, 2005). cited by examiner Grutz et al., Oncogene vol. 17, p. 2799-2803, 1998 (IDS, Feb. 4, 2005). cited by examiner Tse et al, Mammalian genome vol. 10, p. 1089-94, 1999. cited by examiner Yu et al, molecular Cancer, vol. 7, p. 93, Dec. 2008. cited by examiner Visvader et al PNAS, vol. 98, p. 14452-14457, Dec. 2001, (IDS filed Feb. 4, 2005, p. 6, item 1). cited by examiner Visvader, Jane E., et al., “The LIM domain gene LMO4 inhibits differentiation mammary epithelial cells in vitro and is overexpressed in breast cancer”, Proceedings of the National Academy of Sciences (2001), vol. 98, No. 25, pp. 14452-14457. cited by other Kenny, Daryn A., et al., “Identification and characterization of LM04, an LMO gene with a novel pattern of expression during embryogenesis”, Proceedings of the National Academy of Sciences (1998), vol. 95, pp. 11257-11262. cited by other Sugihara, Tod M., et al., “Mouse Deformed epidermal autoregulatory factor 1 recruits a LIM domain factor, LMO-4, and CLIM coregulators”, Proceedings of the National Academy of Sciences (1998), vol. 95, pp. 15418-15423. cited by other Grutz, G., et al., “Identification of the LMO4 gene encoding an interaction partner of the LIM-binding protein LDB1/NL11: a candidate for displacement by LMO proteins in T cell acute leukemia”, Oncogene (1998), vol. 17, pp. 2799-2803. cited by other Tse, Eric, et al., “Characterization of the Lmo4 gene encoding a LIM-only protein: genomic organization and comparative chromosomal mapping”, Mammalian Genome (1999), vol. 10, pp. 1089-1094. cited by other Racevskis, J. et al., “Molecular cloning of LM04, a new human LIM domain gene”, Biochimica et Biophysica Acta 1445: 148-153 (1999). cited by other Communication stating Notice of Reasons for Rejection dated Sep. 10, 2008 Re: Japanese Patent Application No, 2003-527424. cited by other Communication Pursuant to Article 94(3) EPC dated Oct. 13, 2008 from the European Patent Office Re: European Patent Application No. 02753953.5. cited by other Visvader et al,, “The LIM-domain binding protein Ldb1 and its partner LM02 act as negative regulators of erythroid differentiation”, Proc. Nad. Acad. Sci. USA 94: 13707-13712 (1997). cited by other |
| Assistant Examiner: | Yao, Lei |
| Primary Examiner: | Helms, Larry R. |
| Attorney, Agent or Firm: | Scully, Scott, Murphy & Presser, P.C. |
| Accession Number: | edspgr.07700271 |
| Database: | USPTO Patent Grants |
| Language: | English |
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