Celsion’s OVATION 1 Study with GEN-1 in Ovarian Cancer Shows Strong Progression-Free Survival Treatment Effect Utilizing Medidata Synthetic Control Arm
Celsion Corporation (CLSN)
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Source: GlobeNewswire
Hazard Ratio of 0.53 for PFS in the Phase I Intent-To-Treat Population Synthetic Randomization Provides Means to Evaluate Strategies to Accelerate GEN-1 Clinical Program for Newly Diagnosed Stage III/IV Ovarian Cancer LAWRENCEVILLE, N.J., March 26, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today jointly announced with Medidata, a Dassault Systèmes company, that examining matched patient data provided by Medidata in a synthetic control arm (SCA) with results from the Company’s completed Phase Ib dose-escalating OVATION I Study with GEN-1 in Stage III/IV ovarian cancer patients showed positive results in progression-free survival (PFS). The hazard ratio (HR) was 0.53 in the intent-to-treat (ITT) group, showing strong signals of efficacy. 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 ena
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