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Seth Lederman

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Seth Lederman
Seth Lederman
Born (1957-07-30) July 30, 1957 (age 67)
New York, New York, United States
Alma materPrinceton University, Columbia University
Known forBasic and translational research in immunology and therapeutics for autoimmunity, cancer and central nervous system disorders
Scientific career
FieldsImmunology, medicine, and pharmaceuticals
InstitutionsTonix Pharmaceuticals

Seth Lederman, MD is a physician,[1] scientist and specialty pharmaceuticals entrepreneur. He is a co-founder and the current President and Chairman[2][3] of Tonix Pharmaceuticals,[4] a specialty pharmaceutical product development and commercialization company.

Biography

Lederman earned his Bachelor's degree in Chemistry from Princeton University where he graduated cum laude in 1979.[5] He completed his M.D. from Columbia University in 1983[6] and continued his training at the Columbia Presbyterian Medical Center until 1986. Lederman became instructor at Columbia in 1985, Assistant Professor in 1988 and Associate Professor with tenure in 1996. In 2015 he took a leave from Columbia.

As Assistant Professor at Columbia, Dr. Lederman discovered the CD40-Ligand (CD154) and elucidated the molecular basis of T cell helper function. Dr. Lederman’s work on the CD40-Ligand (CD154) led to the development of therapeutic candidates for autoimmune diseases and organ transplant rejection in collaboration with Biogen and UCB/CellTech.[2] He also collaborated with Professor David Baltimore in identifying and functionally characterizing the CD40 signaling molecule, TRAF-3.[7] Dr. Lederman’s “early work on HIV contributed to the understanding of how the V3 loop of HIV gp120 was involved in fusion with CD4 cell membranes, an early and essential event in viral entry and infection”.[8]

Lederman founded Targent Pharmaceuticals, which sold levoleucovorin to Spectrum Pharmaceuticals, who market it as Fusilev. Fusilev is approved for the treatment of advanced colorectal cancer and for methotrexate rescue. Lederman co-founded and served as a managing partner of Konanda Pharma Partners and Konanda Pharma Fund I, LP, and its wholly owned operating companies, Validus and Fontus Pharmaceuticals Inc. Validus acquired Fontus and markets Equetro (carbamazepine – Extended Release), Marplan (isocarboxazid) and Rocaltrol (calcitriol).[2]

Tonix Pharmaceuticals

As of April 2016, Tonix had approximately twenty-five employees. Lederman is a co-founder and current CEO;.[4] Bradley Saenger, CPA and Bruce Daugherty, PhD hold positions of CFO and CSO, respectively.[3] Founded in 2007 and based in New York City,[3] the company specializes in developing next generation medicines for central nervous system disorders. Among the current projects of the company is the development of TNX-102 SL (cyclobenzaprine HCl, 2.8 mg tablets for sublingual administration) for the management of fibromyalgia and for the treatment of post-traumatic stress disorder. TNX-102 SL is currently being tested in a Phase 3 study (the AFFIRM Trial) for fibromyalgia and in a Phase 2 study (the AtEase Trial) for PTSD. In addition, TNX-301 (disulfiram 250 mg/selegiline 4 mg tablets), is in preclinical development. The company was listed on the NASDAQ exchange in 2013 under the symbol TNXP.[4][9] In addition to corporate headquarters in New York City, the company has facilities in La Jolla, CA; San Jose, CA; Montreal, Quebec, Canada and Dublin, Ireland.

Fellowships and grants

  1. 1985-1990 National Institutes of Health, Physician Scientist
  2. 1988-1993 Co-investigator (with Dr. Leonard Chess) "Biologic and Functional Consequences of CD4- gp120 Interactions": Project #1 of PO-1 AI26886, "Pathogenesis of AIDS: Molecular and Cellular Mechanisms", Dr. Leonard Chess, P.I.
  3. 1992-1994 Arthritis Investigator, Arthritis Foundation (National)
  4. 1992-1995 "Differentiation and Function of Human Helper T cells", RO-1 (rank 8.1 percentile), P.I., Seth Lederman.
  5. 1992-1995 "Differentiation and Function of Human Helper T cells", American Cancer Society (Declined).
  6. 1993 Columbia Presbyterian Medical Center, Clinical Research Development Grant, "Preclinical Studies of the mAb 5c8", P.I., Seth Lederman.
  7. 1993-1996 "Preclinical Studies of the mAb 5c8", P.I. with Dr. Leonard Chess, Biogen, Inc.
  8. 1993-1994 Howard Hughes Medical Student Fellowship and Continuing Scholar Award for Sarah M. Fortune.
  9. 1994-1995 Howard Hughes Medical Student Fellowship for Aarif Y. Khakoo
  10. 1996-1999 "Molecular Analysis of Helper T cells Function", American Cancer Society (rank, top 10%. (Declined).
  11. 1996-2001 "Differentiation and Function of Human Helper T cells", RO-1 (rank 7.3 percentile), P.I., Seth Lederman, Competitive renewal.

Selected Publications

  1. Lederman S, Gulick R, Chess L (August 1989). "Dextran sulfate and heparin interact with CD4 molecules to inhibit the binding of coat protein (gp120) of HIV". J. Immunol. 143 (4): 1149–54. PMID 2545782.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  2. Reddy MM, Goetz RR, Gorman JM, Grieco MH, Chess L, Lederman S (1991). "Human immunodeficiency virus type-1 infection of homosexual men is accompanied by a decrease in circulating B cells". J. Acquir. Immune Defic. Syndr. 4 (4): 428–34. PMID 1706770.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  3. Lederman S, DeMartino JA, Daugherty BL, et al. (November 1991). "A single amino acid substitution in a common African allele of the CD4 molecule ablates binding of the monoclonal antibody, OKT4". Mol. Immunol. 28 (11): 1171–81. doi:10.1016/0161-5890(91)90003-3. PMID 1961196.
  4. Yellin MJ, Lee JJ, Chess L, Lederman S (November 1991). "A human CD4- T cell leukemia subclone with contact-dependent helper function". J. Immunol. 147 (10): 3389–95. PMID 1834738.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  5. Lederman S, Yellin MJ, Krichevsky A, Belko J, Lee JJ, Chess L (April 1992). "Identification of a novel surface protein on activated CD4+ T cells that induces contact-dependent B cell differentiation (help)". J. Exp. Med. 175 (4): 1091–101. doi:10.1084/jem.175.4.1091. PMC 2119166. PMID 1348081.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  6. Lederman S, Bergmann JE, Cleary AM, Yellin MJ, Fusco PJ, Chess L (September 1992). "Sulfated polyester interactions with the CD4 molecule and with the third variable loop domain (v3) of gp120 are chemically distinct". AIDS Res. Hum. Retroviruses. 8 (9): 1599–610. doi:10.1089/aid.1992.8.1599. PMID 1457206.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  7. Lederman S, Yellin MJ, Inghirami G, Lee JJ, Knowles DM, Chess L (December 1992). "Molecular interactions mediating T-B lymphocyte collaboration in human lymphoid follicles. Roles of T cell-B-cell-activating molecule (5c8 antigen) and CD40 in contact-dependent help". J. Immunol. 149 (12): 3817–26. PMID 1281189.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  8. Stein CA, Cleary AM, Yakubov L, Lederman S (1993). "Phosphorothioate oligodeoxynucleotides bind to the third variable loop domain (v3) of human immunodeficiency virus type 1 gp120". Antisense Res. Dev. 3 (1): 19–31. PMID 8495104.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  9. Ramesh N, Fuleihan R, Ramesh V, et al. (July 1993). "Deletions in the ligand for CD40 in X-linked immunoglobulin deficiency with normal or elevated IgM (HIGMX-1)". Int. Immunol. 5 (7): 769–73. doi:10.1093/intimm/5.7.769. PMID 8103673.
  10. Yellin MJ, Sinning J, Covey LR, et al. (July 1994). "T lymphocyte T cell-B cell-activating molecule/CD40-L molecules induce normal B cells or chronic lymphocytic leukemia B cells to express CD80 (B7/BB-1) and enhance their costimulatory activity". J. Immunol. 153 (2): 666–74. PMID 7517421.
  11. Yellin MJ, Sippel K, Inghirami G, et al. (January 1994). "CD40 molecules induce down-modulation and endocytosis of T cell surface T cell-B cell activating molecule/CD40-L. Potential role in regulating helper effector function". J. Immunol. 152 (2): 598–608. PMID 7506727.
  12. Lederman S, Yellin MJ, Cleary AM, et al. (March 1994). "T-BAM/CD40-L on helper T lymphocytes augments lymphokine-induced B cell Ig isotype switch recombination and rescues B cells from programmed cell death". J. Immunol. 152 (5): 2163–71. PMID 7907632.
  13. Covey LR, Cleary AM, Yellin MJ, et al. (April 1994). "Isolation of cDNAs encoding T-BAM, a surface glycoprotein on CD4+ T cells mediating contact-dependent helper function for B cells: identity with the CD40-ligand". Mol. Immunol. 31 (6): 471–84. doi:10.1016/0161-5890(94)90066-3. PMID 7514269.
  14. Cheng G, Cleary AM, Ye ZS, Hong DI, Lederman S, Baltimore D (March 1995). "Involvement of CRAF1, a relative of TRAF, in CD40 signaling". Science. 267 (5203): 1494–8. doi:10.1126/science.7533327. PMID 7533327.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  15. Cleary AM, Fortune SM, Yellin MJ, Chess L, Lederman S (October 1995). "Opposing roles of CD95 (Fas/APO-1) and CD40 in the death and rescue of human low density tonsillar B cells". J. Immunol. 155 (7): 3329–37. PMID 7561026.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  16. Karpusas M, Hsu YM, Wang JH, et al. (October 1995). "2 A crystal structure of an extracellular fragment of human CD40 ligand". Structure. 3 (10): 1031–9. doi:10.1016/S0969-2126(01)00239-8. PMID 8589998.
  17. Lederman S, Sullivan G, Benimetskaya L, et al. (1996). "Polydeoxyguanine motifs in a 12-mer phosphorothioate oligodeoxynucleotide augment binding to the v3 loop of HIV-1 gp120 and potency of HIV-1 inhibition independency of G-tetrad formation". Antisense Nucleic Acid Drug Dev. 6 (4): 281–9. doi:10.1089/oli.1.1996.6.281. PMID 9012864.
  18. Sullivan GM, Canfield SM, Lederman S, Xiao E, Ferin M, Wardlaw SL (1997). "Intracerebroventricular injection of interleukin-1 suppresses peripheral lymphocyte function in the primate". Neuroimmunomodulation. 4 (1): 12–8. PMID 9326740.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  19. Liu QY, Rubin MA, Omene C, Lederman S, Stein CA (July 1998). "Fas ligand is constitutively secreted by prostate cancer cells in vitro". Clin. Cancer Res. 4 (7): 1803–11. PMID 9676859.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  20. van Eyndhoven WG, Frank D, Kalachikov S, et al. (December 1998). "A single gene for human TRAF-3 at chromosome 14q32.3 encodes a variety of mRNA species by alternative polyadenylation, mRNA splicing and transcription initiation". Mol. Immunol. 35 (18): 1189–206. doi:10.1016/S0161-5890(98)00099-6. PMID 10199393.
  21. van Eyndhoven WG, Gamper CJ, Cho E, Mackus WJ, Lederman S (July 1999). "TRAF-3 mRNA splice-deletion variants encode isoforms that induce NF-kappaB activation". Mol. Immunol. 36 (10): 647–58. doi:10.1016/S0161-5890(99)00079-6. PMID 10509816.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  22. Gamper C, van Eyndhoven WG, Schweiger E, Mossbacher M, Koo B, Lederman S (2000). "TRAF-3 interacts with p62 nucleoporin, a component of the nuclear pore central plug that binds classical NLS-containing import complexes". Mol. Immunol. 37 (1–2): 73–84. doi:10.1016/S0161-5890(00)00015-8. PMID 10781837.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  23. Gamper C, Omene CO, van Eyndhoven WG, Glassman GD, Lederman S (October 2001). "Expression and function of TRAF-3 splice-variant isoforms in human lymphoma cell lines". Hum. Immunol. 62 (10): 1167–77. doi:10.1016/S0198-8859(01)00284-1. PMID 11600226.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  24. van der Kolk, L E (2002). "CD20-induced B cell death can bypass mitochondria and caspase activation". Leukemia. 16 (9): 1735–1744. doi:10.1038/sj.leu.2402559. PMID 12200688.
  25. Moldofsky H, Harris HW, Archambault WT, Kwong T, Lederman S (December 2011). "Effects of bedtime very low dose cyclobenzaprine on symptoms and sleep physiology in patients with fibromyalgia syndrome: a double-blind randomized placebo-controlled study". J. Rheumatol. 38 (12): 2653–63. doi:10.3899/jrheum.110194. PMID 21885490.{{cite journal}}: CS1 maint: multiple names: authors list (link)

Review Articles

  1. Lederman S, Yellin MJ, Covey LR, Cleary AM, Callard R, Chess L (June 1993). "Non-antigen signals for B-cell growth and differentiation to antibody secretion". Curr. Opin. Immunol. 5 (3): 439–44. doi:10.1016/0952-7915(93)90066-2. PMID 7688518.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  2. Lederman S, Yellin MJ, Cleary AM, Fortune SM, Chess L (1994). "The understanding of contact-dependent T-cell helper function in molecular, cellular and physiological detail". Res. Immunol. 145 (3): 215–21, discussion 244–9. doi:10.1016/s0923-2494(94)80187-8. PMID 7527578.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  3. Lederman S, Cleary AM, Yellin MJ, et al. (January 1996). "The central role of the CD40-ligand and CD40 pathway in T-lymphocyte-mediated differentiation of B lymphocytes". Curr. Opin. Hematol. 3 (1): 77–86. doi:10.1097/00062752-199603010-00012. PMID 9372055.
  4. Lederman S, Suciu-Foca N (July 1999). "Antigen presenting cells integrate opposing signals from CD4+ and CD8+ regulatory T lymphocytes to arbitrate the outcomes of immune responses". Hum. Immunol. 60 (7): 533–61. doi:10.1016/s0198-8859(99)00045-2. PMID 10426271.
  5. Lederman S (2001). "The role of CD154 (CD40-ligand) in costimulation". Transplant. Proc. 33 (1–2): 202–6. doi:10.1016/s0041-1345(00)01975-8. PMID 11266780.

Patents

  1. U.S. Patent #5,474,771[10] (Issued December 12, 1995) “Murine monoclonal antibody (5c8) recognizes a human glycoprotein on the surface of T lymphocytes, Compositions containing same,” Lederman, S., L. Chess and M.J. Yellin.
  2. U.S. Patent #5,756,710[11] (Issued May 26, 1998) “Phosphorothioate oligonucleotides that bind to the V3-loop and uses thereof.” Stein, C.A., S. Lederman and G. Sullivan.
  3. U.S. Patent #5,933,816 (Issued November 30, 1999) “Methods to inhibit humoral immune responses, immunoglobulin production, and B cell activation with 5c8-specific antibodies”, Lederman, S., L. Chess and M.J. Yellin.
  4. U.S. Patent #6,331,433 B1 (Issued December 18, 2001) “Human T cell leukemia cell line designated D1.1”, Lederman, S., L. Chess and M.J. Yellin.[12]
  5. U.S. Patent #6,331,615 B1 (Issued December 18, 2001) “Nucleic acid molecule encoding heavy or light chain of an antibody which specifically recognizes a protein specifically recognized by monoclonal antibody 5c8 (anti-CD40 ligand),” Lederman, S., L. Chess and M.J. Yellin.[13]
  6. U.S. Patent #6,340,459 B1 (Issued January 22, 2002) “Therapeutic applications for the anti-T-BAM (CD40-L) monoclonal antibody 5c8 in the treatment of reperfusion injury in non-transplant recipients”, Yellin, M.J., Lederman, S., and L. Chess.[14]
  7. U.S. Patent #6,358,944 B1 (Issued March 19, 2002) “Methods and compositions for treating generalized anxiety disorder”, Lederman, S., I. W. Iglehart.[15]
  8. U.S. Patent #6,403,091 B1 (Issued June 11, 2002) “Methods for inhibiting the rejection of a transplant organ in a subject with 5c8-specific antibodies”, Lederman, S, M.J. Yellin, and L. Chess.[16]
  9. U.S. Patent #6,410,710 B1 (Issued June 25, 2002) “Nucleic acid encoding TRAF-3 deletion isoform”, Lederman, S., W. van Eyndhoven.[17]
  10. U.S. Patent #6,451,310 B1 (Issued September 17, 2002) “A method for inhibiting an allergic response with a 5c8-specific antibody”, Lederman, S, M.J. Yellin, and L. Chess.[18]
  11. U.S. Patent #6,455,044 B1 (Issued September 24, 2002) “5c8 Antigen”, Lederman, S., M.J. Yellin, and L. Chess.[19]
  12. U.S. Patent #6,592,868 B1 (Issued July 15, 2003) “Methods for treating autoimmune disease”, Lederman, S., M.J. Yellin, and L. Chess.
  13. U.S. Patent #6,610,294 B1 (Issued August 26, 2003) “Methods of inhibiting an autoimmune response in a human suffering from an autoimmune disease by administering an antibody that binds to a protein to which monoclonal antibody 5c8 binds”, Lederman, S., M.J. Yellin, and L. Chess.[20]
  14. U.S. Patent #6,793,924 (Issued September 21, 2004) “Protein recognized by an antibody that specifically binds an epitope that is specifically bound by monoclonal antibody 5c8”, Lederman, S., L. Chess and M.J. Yellin.[21]
  15. U.S. Patent #6,822,070 B2 (Issued November 23, 2004) “Truncated CRAF1 inhibits CD40 signaling.”, Baltimore, D, G. Cheng, Z-S Ye, S. Lederman, and A. Cleary.[22]
  16. U.S. Patent #6,849,415 B2 (Issued February 1, 2005) “TRAF -3 deletion isoforms and uses thereof”, Lederman, S., W. van Eyndhoven.[23]
  17. US Patent #7,070,777 (Issued July 4, 2006) “Method for inhibiting inflammation with an antibody that binds the 5C8 protein,” Lederman, S., L. Chess and M.J. Yellin[24]
  18. US Patent 12/145,792 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism” (notice of allowance) . Lederman, S.[25]
  19. Australia Patent AU 2002354017 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism”. Lederman, S.
  20. Canada Patent CA 2463987 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism”. Lederman, S.
  21. European Patent EP 1441708 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism”. Lederman, S.
  22. New Zealand Patent NZ 532583 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism” Lederman, S.

Honors and Awards

  1. 1993 Dr. Harold and Golden Lamport Award for Excellence in Clinical Science Research
  2. 1993 New York Arthritis Foundation Grant Reviewer
  3. 1993 Ad Hoc Reviewer; Immunochemical Sciences Study Section, N.I.H.
  4. 1993 Ad Hoc Reviewer; Aids and Related Research Study Section (1), N.I.H.
  5. 1994-1996 Medical and Scientific Committee, N.Y. Chapter of the Arthritis Foundation
  6. 1994-1995 Scientific Program Abstract Reviewer - Am. College of Rheumatology Nat'l Meeting
  7. 1996 Ad Hoc Reviewer, American Cancer Society, Immunology Study Section
  8. 1999 Scientific Program Abstract Reviewer - Am. College of Rheumatology Nat'l Meeting
  9. 1998-2001 Grant Review Committee – Nat’l Arthritis Foundation, Cellular Immunology
  10. 2000-2005 American Editor – Human Immunology

References

  1. ^ "Executive Profile". Bloomberg Business Week Executive Profiles. Bloomberg Business Week.
  2. ^ a b c "About Us - Board of Directors". Tonix Pharmaceuticals. Retrieved 15 December 2011.
  3. ^ a b c "Management Team". Tonix Pharmaceuticals. Archived from the original on 23 May 2013. Retrieved 10 March 2014. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  4. ^ a b c Dutton, Gail (15 January 2014). "Tonix Targets Reformulation to Create Value". BioBusiness. Vol. 34, no. 4. p. 10.
  5. ^ "Department of Medicine Faculty". Columbia University website. Retrieved 30 January 2012.
  6. ^ "Research Faculty - Seth Lederman, M.D." Columbia University Website. Retrieved 30 January 2012.
  7. ^ "Research Summary". Seth Lederman. Retrieved 30 January 2012.
  8. ^ Bloomberg Businessweek http://investing.businessweek.com/research/stocks/private/person.asp?personId=8182470&privcapId=34656951&previousCapId=8171005&previousTitle=Targent,%20Inc. Retrieved 15 December 2011. {{cite news}}: Missing or empty |title= (help)
  9. ^ Nasdaq: TNXP
  10. ^ "Patent 5,474,771" (PDF). UNITED STATES PATENT AND TRADEMARK OFFICE. U.S. Patent Office.
  11. ^ "US 5756710". Patent Lens. Patentlens.com.
  12. ^ "Therapeutic applications for the anti-T-BAM (CD40-L) monoclonal antibody 5C8 in the treatment of reperfusion injury in non-transplant recipients". Google Patents. Google. Retrieved 21 December 2011.
  13. ^ "Murine monoclonal antibody (5c8) recognizes a human glycoprotein on the surface of T-lymphocytes, compositions containing same". Google Patents. Google. Retrieved 21 December 2011.
  14. ^ "Therapeutic applications for the anti-T-BAM (CD40-L) monoclonal antibody". Google Patents. Google.
  15. ^ "U.S. Patent Number: 6,358,944". Patents. Justia Patents. Retrieved 21 December 2011.
  16. ^ "Methods for inhibiting the rejection of a transplant organ in a subject". Google documents. Google.
  17. ^ "Nucleic acid encoding a TRAF-3 deletion isoform". Google Patents. Google. Retrieved 21 December 2011.
  18. ^ "Method for inhibiting an allergic response with a 5c8-specific antibody". Google Patents. Google. Retrieved 21 December 2011.
  19. ^ "5c8 Antigen". Google Patents. Google. Retrieved 21 December 2011.
  20. ^ "Methods of inhibiting an autoimmune response in a human suffering from an autoimmune disease by administering an antibody that binds to a protein to which monoclonal antibody 5c8 binds". Google Patents. Google. Retrieved 21 December 2011.
  21. ^ "Protein recognized by an antibody that specifically binds an epitope that is specifically bound by monoclonal antibody 5c8". Google Patents. Google.
  22. ^ "Truncated CRAF1 inhibits CD40 signaling". Patent Abstracts. Columbia Technology Ventures. Retrieved 21 December 2011.
  23. ^ "TRAF -3 deletion isoforms and uses thereof". Patentscope. World intellectual property organization. Retrieved 21 December 2011.
  24. ^ "Method for inhibiting inflammation with an antibody that binds the 5C8 protein". Google Patents. Google. Retrieved 21 December 2011.
  25. ^ "Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism". Google Patents. Google. Retrieved 21 December 2011.

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