Immunovaccine Inc. (IMV.V), a clinical stage vaccine and immunotherapy company, announced that DPX-Survivac, the firm's lead cancer vaccine candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration or FDA as maintenance therapy in subjects with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival. Ovarian cancer patients who have no measurable disease following their initial standard surgery and chemotherapy treatments have an unmet need that may be served by the DPX-Survivac therapy.
DPX-Survivac is designed to activate T cells of the immune system that are expected to recognize and eliminate cancer cells in an attempt to keep patients in remission longer.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs with the potential to treat serious or life-threatening conditions and address an unmet medical need.
Recently, the company received clearance from Health Canada to conduct a Phase II clinical study of DPX-Survivac in patients with diffuse large B cell lymphoma (DLBCL). The Company-sponsored study, expected to begin in early 2015, would assess DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. Immunovaccine expects initial data from this study in the second half of 2015. Positive trial results could provide rationale for the initiation of a pivotal trial in recurrent DLBCL which could lead to the approval of DPX-Survivac for the treatment of DLBCL.
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