Issues in pharmaceutical development of thymosin α1 from preclinical studies through marketing

Annals of the New York Academy of Sciences

Volumn 1112, Issue , 2007, Pages 351-356

  Tuthill, Cynthia ^a  

^a SciClone Pharmaceuticals Inc   (United States)

Author keywords

Commercial approval; Registration; Thymosin; Zadaxin

Indexed keywords

ALPHA INTERFERON; INFLUENZA VACCINE; THYMOSIN ALPHA1;

ANTINEOPLASTIC ACTIVITY; ANTIVIRAL ACTIVITY; CHRONIC HEPATITIS; CONFERENCE PAPER; DRUG APPROVAL; DRUG DESIGN; DRUG INDUSTRY; DRUG MARKETING; DRUG MECHANISM; DRUG RESEARCH; HEPATITIS B; HEPATITIS C; HUMAN; IMMUNOMODULATION; INFLUENZA; MELANOMA; MONOTHERAPY; THERAPY EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE;

EID: 35348968283     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1196/annals.1415.007     Document Type: Conference Paper

References (20)

1. GIULIANI, C. et al. 2000. Thymosin alpha 1 regulates MHC class I expression in FRTL-5 cells at transcriptional level. Eur. J. Immunol. 30: 778-786.
2. ROMANI, L. et al. 2004. Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through Toll-like receptor signaling. Blood 103: 4232-4239.
3. ZHANG, P. et al. 2005. Activation of IKK by thymosin alpha 1 requires the TRAF6 signalling pathway. EMBO Rep. 6: 531-537.
4. ROMANI, L. et al. 2006. Thymosin alpha 1 activates dendritic cell tryptophan catabolism and establishes a regulatory environment for balance of inflammation and tolerance. Blood 108: 2265-2273.
5. KAGESHITA, T., S. HIRAI, T. ONO, et al. 1999. Down-regulation of HLA class I antigen-processing molecules in malignant melanoma: association with disease progression. Am. J. Pathol. 154: 745-754.
6. CHANG, C.C., T. OGINO, D.W. MULLINS, et al. 2006. Defective human leukocyte antigen class I-associated antigen presentation caused by a novel beta2-microglobulin loss-of-function in melanoma cells. J. Biol. Chem. 281: 18763-18773.
7. LIU, C., A. PATEL, H. ZHU, et al. 2002. In vitro studies to identify host genes or pathways involved in immune-mediated response to thymosin alpha 1 and peginterferon. Hepatol. Gastroenterol.
8. CLEMENTE, C.G., M.C. MIHM, Jr., R. BUFALINO, et al. 1996. Prognostic value of tumor infiltrating lymphocytes in the vertical growth phase of primary cutaneous melanoma. Cancer 77: 1303-1310.
9. HAANEN, J.B., A. BAARS, R. GOMEZ, et al. 2006. Melanoma-specific tumor-infiltrating lymphocytes but not circulating melanoma-specific T cells may predict survival in resected advanced-stage melanoma patients. Cancer Immunol. Immunother. 55: 451-458.
10. KIRKWOOD, J.M., J.G. IBRAHIM, J.A. SOSMAN, et al. 2001. High-dose interferon alfa-2b significantly prolongs relapse-free and overall survival compared with the GM2-KLH/QS-21 vaccine in patients with resected stage IIB-III melanoma: results of Intergroup Trial E1694/S9512/CSO9801. J. Clin. Oncol. 19: 2370-2380.
11. KIRKWOOD, J. 2002. Cancer immunotherapy: the interferon-alpha experience. Semin. Oncol. 29: 18-26.
12. WENZEL, J., B. BEKISCH, M. UERLICH, et al. 2005. Type I interferon-associated recruitment of cytotoxic lymphocytes. Am. J. Clin. Pathol. 124: 37-48.
13. KNUTSEN, A.P., J.J. FREEMAN, K.R. MUELLER, et al. 1999. Thymosin-alpha1 stimulates maturation of CD34+ stem cells into CD3 + 4+ cells in an in vitro thymic epithelia organ coculture model. Int. J. Immunopharmacol. 21: 15-26.
14. KULLAVANIJAYA, P. et al. 2001. The combined treatment of interferon alpha-2 and thymosin alpha 1 for chronic hepatitis C: the 48 weeks end of treatment results. J. Med. Assoc. Thailand 84: S462-S467.
15. SUGAHARA, S. et al. 2002. Thymosin alpha 1 increases intrahepatic natural killer T cells and cytotoxic T lymphocytes in the patients with chronic hepatitis B. J. Gastroenterol. Hepatol. 17: A100.
16. AMARAPURKAR, D. & H.S. DAS. 2002. Thymosin alpha in the treatment of chronic hepatitis B: an uncontrolled open-label trial. Indian Soc. Gastroenterol. 21: 59-61.
17. TSAI, S.-L. et al. 2003. Activation of Th1 immunity is a common immune mechanism for the successful treatment of hepatitis B and C: tetramer assay and therapeutic implications. J. Biomed. Sci. 10: 120-135.
18. TANG, J.-H. et al. 1998. Emergence of an S gene mutant during thymosin alpha 1 therapy in a patient with chronic hepatitis B. J. Infect. Dis. 178: 866-869.
19. CHIEN, R. et al. 1998. Efficacy of thymosin α1 in patients with chronic hepatitis B: a randomized, controlled trial. Hepatology 27: 1383-1387.
20. LIAW, Y.-F. 2004. Thymalfasin (thymosin alpha 1) therapy in patients with chronic hepatitis B. J. Gastroenterol. Hepatol. 19: S73-S75.