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Review

Zadaxin (thymosin α1) for the treatment of viral hepatitis

Pages 281-287 | Published online: 23 Feb 2005

Bibliography

  • BERENGUER M, WRIGHT TL: Hepatitis B and C viruses:molecular identification and targeted antiviral thera-pies. Proc. Am. Physicians (1998) 110:98–112.
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  • NIH: Management of hepatitis C [consensus state-ment]. (March 24–26, 1997) 15: 1–41.
  • NICOLL A, LOCARNINI S: Present and future directions in the treatment of chronic hepatitis B infection. J. Gas-troenterol. Hepatol. (1997) 12:843–854.
  • MURAKAMI T, KIM T, NAKAMURA H: Hepatitis, cirrhosis and hepatoma. J. Magn. Reson. Imaging (1998) 8:346–358.
  • BELLE SH, BERRINGER KC, DETRE KM: An update on liver transplantation in the United States. Recent char-acteristics and outcome. Clin. Transplant (1995)1575–1578.
  • MUTCHNICK MG, EHRINPREIS MN, KINZIE JL, PELEMAN RP: Perspectives on the treatment of chronic hepatitis B and chronic hepatitis with thymic peptides and an-tiviral agents. Antiviral Res. (1994) 24:245–257.
  • NAYLOR PH, MUTCHNICK MG: Thymus-derived pep-tides in the treatment of viral chronic hepatitis. Dig. Dis. (1996) 14(6):362–370.
  • •This reviews thymosin in the context of other thymic pep-tides and has a good discussion of the potential mechanism of action.
  • TSAI SL, HUANG SN: T cell mechanisms in the immuno-pathogenesis of viral hepatitis B and C. J. Gastroenterol. Hepatol (1997) 12:S227–S235.
  • CHISARI FV, FERRARI C: Hepatitis B virus immunopho-genesis. Ann. Rev. Immunol (1995) 13:29–60.
  • SCHOUVAL D: Vaccines for prevention of viral hepati-tis. Haemophilia (1998) 4:587–595.
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  • LIVINGSTON DB, CRIMI C, GREY H et al: The hepatitis B virus-specific CTL response induced in humans by lipopeptide vaccination are comparable to those elic-ited by acute viral infection. J. Immunol. (1997) 159:1383–1392.
  • NAYLOR PH, GOLDSTEIN AL: Thymosin modulates im-mune and endocrine events. Prog. Clin. Biol. Res. (1988) 256:489–502.
  • GOLDSTEIN AL, GUPTA A, ZATZ MM, HARDY M, WHITEA: Purification and biological activity of thymosin, a hormone of the thymus gland. Proc. Natl. Acad. USA (1972) 69:1800–1812.
  • SCHULOF RS, NAYLOR PH, SZTEIN MB, GOLDSTEIN AL:Thymic Physiology and Biochemistry. Adv. Clinical Chemistry (1987) 26:203–292.
  • SERRATE SA, SCHULOFF RS, LEONDARIDAS L, GOLD-STEIN AL, SZTEIN MB: Modulation of human natural kil-ler cell cytotoxic activity, lymphokine production, and interleukin 2 receptor expression by thymic hor-mones. J. Immunol. (1987) 139:2338–2343.
  • SVEDERSKY LF, HUI A, MAY L, MCKAY P, SIEBBING N: In-duction and augmentation of mitogen induced inter-feron production in human peripheral blood lymphocytes by desacetyl thymosin al. Eur. J. Immunol (1982) 12:244–247.
  • SZTEIN MB, SERRATE SA, GOLDSTEIN AL: Modulation of interleukin 2 receptor expression on normal human lymphocytes by thymic hormones. Proc. Natl. Acad. Sci. USA (1986) 83:6107–6111.
  • •Central paper demonstrating that Ta 1 has the potential to act on pest thymic cells and that the mechanism of action may be through up-regualtion of the IL-2 receptor.
  • MUTCHNICK MG, MISSIRIAN A, JOHNSON AG: Lympho-cyte cytotoxicity in human liver disease using rat he-patocyte monolayer cultures. Clin. Immunol. Immunopathol (1980) 16:423–437.
  • MUTCHNICK MG, PRIETO JA, SCHAFFNER JA, WELLER FE: Thymosin modulation of regulatory T cell function. Clin. Immuno. Immunopathol (1982) 23:626–633.
  • MUTCHNICK MG, SCHAFFNER JA, PRIETO JA, WELLER FE, GOLDSTEIN AL: Increased thymic hormone responsive suppresser T lymphocyte function in chronic active hepatitis. Dig. Dis. Sci. (1983) 28:328–334.
  • GARACI E, PICA F, RASI G, PALAMARA AT, FAVALLI C: Combination therapy with BRM's in cancer and infec-tious diseases. Mech. Ageing Dev. (1997) 96:103–116.
  • WANG SS, MAKOFSKE R, BACH A, MERRIFIELD RB: Syn-thesis of thymosin alpha one. Int. J. Pept. Protein Res. (1980) 15:1–4.
  • SCHULOF R, LLOYD JJ, COX J et al: An evaluation of twodifferent schedules of synthetic thymosin alpha 1 ad-ministration in patients with lung cancer. In: Thymic Hormones and Lymphokines Goldstein AL (Ed.), Plenum Press, New York (1984):601–613.
  • NAYLOR PH, NAYLOR CW, SASAKI D, MUTCHNICK MG: Utilization of HPLC-ELISA to assess serum levels of thy-mosin al following subcutaneous administration to human subjects. J. Liquid Chromatography (1994) 17:3541–3551.
  • PETERS M, VEIRLINE J, GERSHWIN E, MILICH D, CHISARI FV, HOOFNAGLE JH: Immunology and the liver. Hepa-tology (1991) 13:977–994.
  • MUTCHNICK MG, CUMMINGS GD, HOOFNAGLE JH, SHAFRITZ DA: Thymosin: an innovative approach to the treatment of chronic hepatitis B. In: Combination Therapies. Goldstein AL, Garaci E (Eds.), Plenum Press, New York (1992):149–157.
  • ZAVYALOV VP, DENESYUK Al, ZAVYALOVA GA: Theo-retical analysis of conformation and active sites of in-terferons. Immunol. Lett. (1989) 22:173–181.
  • YARED, G, HUSSAIN, KB, NATHANI MG et al.: Cytokine mediated apoptosis and inhibition of virus production and anchorage independent growth of viral trans-fected hepatoblastoma cells. Cytokine (1998) 10:586–95.
  • MOSHIER JA, MUTCHNICK MG, DOSESCU J et al.: Thymosin-alpha 1, but not interferon-alpha, specifi-cally inhibits anchorage-independent growth of hepa-titis B viral transfected HepG2 cells. J. Hepatol. (1996) 25 (6):814–820.
  • GERIN JL, KORBA BE, COTE PJ, TENNANT BC: A prelimi-nary report of a controlled study of thymosin alpha 1 in the woodchuck model of hepadnavirus infection. In: Innovations in Antiviral Development and the Detection of Virus Infection. Black T et al. (Eds.), Plenum Press, New York (1992):121–123.
  • ••Only relevant preclinical study demonstrating that Tal hasthe potential to be active in viral hepatitis. It also provides clues as to the potential mechanism of action and for opti-mal therapeutic utilisation.
  • MUTCHNICK MG, APPELMAN, HD, HUNG HT et al.: Thy-mosin treatment of chronic hepatitis B: A placebo-controlled pilot trial. Hepatology (1991) 14:409–415.
  • MUTCHNICK MG, JAUREQUI JI, SHAFRITZ DA: Sustained response to thymosin therapy in patients with chronic hepatitis B. In: Combination Therapies. Goldstein AL, Garaci E (Eds.), Plenum Press, New York (1992):217–223.
  • •First clinical study to demonstrate the potential of Tal in hepatitis C and provides useful information regarding the mechanism of action.
  • REZAKOVIC I, MONDAZZI L, ASTI L, IDEO G: Thymosinalpha 1 versus alpha- interferon treatment of HBsAg, HBeAb, HBV DNA positive chronic active hepatitis. He-patology (1992) 16:67A.
  • ANDREONE P, CURSARO C, GRAMENZI A et al.: Prelimi-nary results of thymosin al vs. IFN-a treatment in pa-tients with HBsAg negative and HBVDNA positive chronic active hepatitis. Int. J. Immunotherapy (1993) 124:201–205.
  • ANDREONE P, CURSARO C, GRAMENZI A et al.: A ran- domized controlled trial of thymosin-alphal versus interferon alpha treatment in patients with hepatitis B antigen antibody and hepatitis B virus DNA positive chronic hepatitis B. Hepatology (1996) 24(4)774–777.
  • •Addresses the Italian experience with Tal in hepatits B patients.
  • MUTCHNICK MG, LINDSAY KL, SCHIFF ER, CUMMINGS GD, APPELMAN HD: Thymosin al treatment of chronic hepatitis B: a multicenter randomized, placebo-controlled double bind study. Gastroenterology (1995) 108:1127A.
  • CHIEN RN, HAW YF, CHEN TC, YEH CT, SHEEN IS: Effi- cacy of thymosin alphal in patients with chronic hepatitis B: a randomized, controlled trial. Hepatology (1998) 27(5):1383–1387.
  • •Addresses the Asian experience with Tal in hepatitis B patients.
  • RASI G, MUTCHNICK MG, DIVIRGILIO D et al.: Combina- tion low dose lymphoblastoid interferon (L-IFNa) and thymosin alpha 1 (Tal) therapy in the treatment of chronic hepatitis B. Hepatology (1994) 20:811A.
  • ••Only paper demonstrating that Tal has the potential to en-hance the response to interferon in patients with hepatitis B.
  • ANDREONE P, CURSARO C, GRAMENZI A et al: A double-blind, placebo-controlled, pilot trial of thymosin al-pha 1 for the treatment of chronic hepatitis C. Liver (1996) 16(3):207–210.
  • SHERMAN KE, SJOGREN M, CREAGER RL et al: Combina-tion therapy with thymosin alphal and interferon for the treatment of chronic hepatitis C infection: a ran-domized, placebo-controlled double-blind trial. Hepa-tology (1998) 27(4):1128–1135.
  • ••Only paper to evaluate Tal in combination with IFN-a inhepatitis C patients. Paul H Naylor Department of Internal Medicine, Division of Gastroenterology Wayne State University School of Medicine, Detroit, MI 482001, USA Tel.: +1 313 576 4467; Fax: +1 313 576 1112; Email: [email protected]

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