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ITOR Clinical Research Unit First in Man Trials

A "First-In-Man" Study is a clinical trial where experience with animal testing is extended to human subjects for the first time. These studies are designed to hasten the development of promising drugs by establishing whether the drug or agent behaves in human subjects as predicted from preclinical studies and is safe to undergo further development.

The ITOR Clinical Research Unit (CRU) has conducted a number of first in human trials, some of which established the first worldwide exposure to these new agents.

First in Man trials are listed below:

Open to Enrollment

  • Tokai-001 in Castration Resistant Prostate Cancer:
    Inhibits CYP17, an enzyme that controls androgen production in the adrenals, testes and prostate. Binds to the AR receptor. Decreases the amount of AR protein within the cancer cell and diminishes the ability of the cell to be sustained by low levels of androgens.
  • E7106 in Solid Tumors:
    E7016 is PARP inhibitor. Poly(ADP-ribose) polymerase (PARP) is an abundant nuclear enzyme that mediates repair of DNA single-strand breaks via the activation and recruitment of DNA repair enzymes through synthesizing poly(ADP-ribose) from nicotinamide adenine dinucleotide (NAD).
  • RX-5902 in Solid Tumors:
    A dose finding, open label, phase 1 study of RX-5902 in subjects with advanced or metastatic solid tumors.

Closed to Enrollment

  • Intravesical CG0070 with DDM washing for Transitional Cell Carcinoma of the Bladder:
    CG0070 is a conditionally replicating oncolytic adenovirus regulated by a promoter upregulated in Rb pathway defective tumor cells. It selectively expresses GM-CSF.
  • Seneca Valley Virus (SVV-001) for Neuroendocrine Solid Tumors:
    SVV-001 is a replication competent picornavirus.
  • AZD4877 for Advanced Solid Tumors:
    AZD4877 is an Eg5 inhibitor. Inhibition of Eg5 leads to cell death through the formation of a monopolar spindle (monoaster), arresting cells in mitosis.
  • CG53135 for Chemotherapy Induced Mucositis/Stomatitis:
    CG53135 is a fibroblast growth factor that induces proliferation of epithelial and mesenchymal cells.
  • Dendrivax for Renal Cell Carcinoma:
    Vaccine created by fusing autologous dendritic cells with irradiated tumor cells and given in conjunction with IL-2.
  • Melanix® Vaccine for Melanoma:
    Dendritic cells fused with irradiated tumor cells as a cancer vaccine in conjunction with BCG.
  • JX594 for Advanced Solid Tumors:
    JX594 is a replication-competent, GM-CSF transgene-expressing therapeutic vaccinia virus.