Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency
Celsion Corporation (CLSN)
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Source: GlobeNewswire
Approval Adds 10 Years of Market Exclusivity Following Marketing Authorization in Europe LAWRENCEVILLE, N.J., March 23, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer. GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is an interleukin-12 (IL-12) DNA plasmid vector encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1 previously received orphan designation from the U.S. Food and Drug Administration and is currently being evaluated in a Phase I/II clinical trial (the OVATION 2 Study) for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer. The OVATION 2 Study combi
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