Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from EMA

Celsion 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 combines GEN-1 with the standard of care for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer who will undergo standard neoadjuvant chemotherapy followed by interval debulking surgery. The OVATION 2 Study is a randomized Phase I/II study designed to evaluate the safety of 100 mg/m² of GEN-1 in the Phase I portion, followed by a continuation at the safe dose in the Phase II portion in an open-label, 1:1 randomized design.

"EMA's orphan drug designation for GEN-1 recognizes the urgent need for new therapies to treat ovarian cancer, an aggressive, rapidly progressing disease with few effective treatment options," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "We are pleased to receive a positive opinion from EMA COMP as this Designation carries multiple benefits and represents another important milestone for our clinical program to treat late-stage ovarian cancer."

As established by the EMA, Orphan Medicinal Product Designation (the "Designation") by the European Commission provides for scientific advice and certain regulatory assistance during the product development phase, direct access to centralized marketing authorization and certain financial incentives for companies developing new therapies intended for the treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 people in the European Union (EU).

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