Vigil (Gradalis) is an autologous tumor-based vaccine incorporating a plasmid encoding granulocyte-macrophage colony-stimulating factor (GM-CSF) and a novel, bifunctional short hairpin RNAi that targets furin convertase. Inhibiting the furin pathway blocks the activation of transforming growth factors β1 and β2 (TGF-β1, -β2), which are overexpressed in malignant tissues. The TGF-β family of proteins are known to inhibit T-cell activation and GM-CSF-induced dendritic cell maturation, as well as having antagonistic effects on induction and proliferation of natural killer cells and lymphokine-activated killer cells.
Early results show Vigil (Gradalis) may delay disease recurrence in Stage III/IV ovarian cancer patients with high-grade disease who have received surgery and adjuvant chemotherapy, thereby improving patients’ quality of life. If it gains approval, Vigil will be the only therapeutic vaccine on the ovarian cancer market. However, high manufacturing costs and limited geographic reach will limit Vigil’s overall commercial potential.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Vigil : Ovarian cancer
LIST OF FIGURES
7 Figure 1: Vigil for ovarian cancer – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment of Vigil for ovarian cancer
9 Figure 3: Datamonitor Healthcare’s drug assessment of Vigil for ovarian cancer
LIST OF TABLES
4 Table 1: Vigil drug profile
5 Table 2: Vigil Phase III data in ovarian cancer
6 Table 3: Overview of interim Phase II data for Vigil in ovarian cancer
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