Production of a cellular product consisting of monocytes stimulated with Sylatron (Peginterferon alfa-2b) and Actimmune (Interferon gamma-1b) for human use.

Background: Monocytes are myeloid cells that reside in the blood and bone marrow and respond to inflammation. At the site of inflammation, monocytes express cytokines and chemokines. Monocytes have been shown to be cytotoxic to tumor cells in the presence of pro-inflammatory cytokines such as Interferon Alpha, Interferon Gamma, and IL-6.

A Phase 1 trial of autologous monocytes stimulated ex vivo with Sylatron (Peginterferon alfa-2b) and Actimmune (Interferon gamma-1b) for intra-peritoneal administration in recurrent ovarian cancer.

Background: Ovarian cancer has no definitive second line therapeutic options, and largely recurs in the peritoneal cavity. Locoregional immune therapy using both interferons and monocytes can be used as a novel approach. Interferons have both cytostatic and cytotoxic properties, while monocytes stimulated with interferons have potent cytotoxic properties.