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Gradalis Moves Cancer Vaccine with RNAi Component into Phase III

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NEW YORK (GenomeWeb) – Gradalis announced this week that it has moved its personalized ovarian cancer vaccine Vigil, which combines an RNAi component with an immunostimulator, into Phase III testing.

Vigil, formerly known as FANG, involves engineering a patient's tumor cells to express the immunostimulator recombinant human granulocyte-macrophage colony-stimulating factor, which is designed to elicit a T-cell response against the patient's tumor antigens. The drug also includes bi-functional shRNAs against furin, an enzyme responsible for lysing the components of the protein TGF-beta that are involved in cellular proliferation and differentiation.

The Phase III study is enrolling women with stage III and IV high-grade ovarian cancer who have previously been treated with primary cytoreduction and five to six cycles of chemotherapy.

The trial follows the completion of a Phase II study in which 93 percent of patients experienced T-cell activation against their tumor antigen as early as one month after dosing, according to Gradalis. Vigil was also well tolerated with only mild, local injection-site adverse events.

The company is also testing Vigil in Phase II studies for Ewing's sarcoma, colorectal cancer with liver metastases, and non-small cell lung caner.

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