Pathotropic nanoparticles for cancer gene therapy Rexin-G™ IV: Three-year clinical experience

  • Authors:
    • Erlinda M. Gordon
    • Francisco F. Lopez
    • Gerardo H. Cornelio
    • Conrado C. Lorenzo
    • John P. Levy
    • Rebecca A. Reed
    • Liqiong Liu
    • Howard W. Bruckner
    • Frederick L. Hall
  • View Affiliations

  • Published online on: November 1, 2006     https://doi.org/10.3892/ijo.29.5.1053
  • Pages: 1053-1064
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Abstract

Metastatic cancer is a life-threatening illness with a predictably fatal outcome, thereby representing a major unmet medical need. In 2003, Rexin-G™ became the world's first targeted injectable vector approved for clinical trials in the treatment of intractable metastatic disease. Uniquely suited, by design, to function within the context of the human circulatory system, Rexin-G is a pathotropic (disease-seeking) gene delivery system bearing a designer killer gene; in essence, a targeted nanoparticle that seeks out and selectively accumulates in metastatic sites upon intravenous infusion. The targeted delivery of the cytocidal gene to primary tumors and metastatic foci, in effective local concentrations, compels both cancer cells and tumor-associated neovasculature to self-destruct, without causing untoward collateral damage to non-target organs. In this study: i) we report the results of three distinctive clinical studies which demonstrate the initial proofs of concept, safety, and efficacy of Rexin-G when used as a single agent for advanced or metastatic cancer, ii) we introduce the quantitative foundations of an innovative personalized treatment regimen, designated the ‘Calculus of Parity’, based on a patient's calculated tumor burden, iii) we propose a refinement of surrogate end-points commonly used for defining success in cancer therapy, and iv) we map out a strategic plan for the accelerated approval of Rexin-G based on the oncologic Threshold of Credibility paradigm being developed by the Food and Drug Administration.

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November 2006
Volume 29 Issue 5

Print ISSN: 1019-6439
Online ISSN:1791-2423

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Spandidos Publications style
Gordon EM, Lopez FF, Cornelio GH, Lorenzo CC, Levy JP, Reed RA, Liu L, Bruckner HW and Hall FL: Pathotropic nanoparticles for cancer gene therapy Rexin-G™ IV: Three-year clinical experience. Int J Oncol 29: 1053-1064, 2006.
APA
Gordon, E.M., Lopez, F.F., Cornelio, G.H., Lorenzo, C.C., Levy, J.P., Reed, R.A. ... Hall, F.L. (2006). Pathotropic nanoparticles for cancer gene therapy Rexin-G™ IV: Three-year clinical experience. International Journal of Oncology, 29, 1053-1064. https://doi.org/10.3892/ijo.29.5.1053
MLA
Gordon, E. M., Lopez, F. F., Cornelio, G. H., Lorenzo, C. C., Levy, J. P., Reed, R. A., Liu, L., Bruckner, H. W., Hall, F. L."Pathotropic nanoparticles for cancer gene therapy Rexin-G™ IV: Three-year clinical experience". International Journal of Oncology 29.5 (2006): 1053-1064.
Chicago
Gordon, E. M., Lopez, F. F., Cornelio, G. H., Lorenzo, C. C., Levy, J. P., Reed, R. A., Liu, L., Bruckner, H. W., Hall, F. L."Pathotropic nanoparticles for cancer gene therapy Rexin-G™ IV: Three-year clinical experience". International Journal of Oncology 29, no. 5 (2006): 1053-1064. https://doi.org/10.3892/ijo.29.5.1053