DPX-Survivac: Phase I/II data

Data from 18 ovarian cancer patients previously treated by surgery and chemotherapy in the open-label, dose-ranging Phase I portion of a North American Phase I/II trial showed that all 12 patients receiving subcutaneous DPX-Survivac in combination with low-dose oral cyclophosphamide every 3 weeks for 6 weeks demonstrated antigen-specific immune responses as measured by >=1 of the study's 3 immune monitoring assays (enzyme-linked immunospot (ELISPOT) assay, tetramer analysis and multiparametric intracellular cell staining). Additionally, all 10 patients receiving DPX-Survivac plus cyclophosphamide who were evaluable by tetramer staining produced survivin-specific CD8 T cells following 1 or 2 vaccinations. Furthermore, 0.5 mL DPX-Survivac plus cyclophosphamide produced an average stimulation factor of 600 times over baseline responses following the third vaccination. One patient had an average stimulation factor of 1,200 times over baseline responses. Stimulation factor is the number of interferon (IFN)-positive cells following a short pulse with peptides contained in the vaccine as measured by an ELISPOT assay according to the company. DPX-Survivac was well tolerated with no significant systemic adverse events or dose-limiting toxicities (DLTs) reported. ...