Celsion Corporation (NASDAQ: CLSN) a clinical-stage company focused on DNA-based immunotherapy and next generation vaccines and Medidata, a Dassault Systèmes company, today announced that they will be presenting their findings on the use of a Synthetic Control Arm (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer (the OVATION 1 Study) at the Annual Meeting of the American Association for Cancer Research (AACR) being held on April 8-13 in New Orleans.
In a poster presentation entitled “Phase IB trial efficacy estimates via a clinical trial synthetic control arm”, taking place on Monday April 11 , Dr. Elizabeth Lamont will present the research team’s findings that demonstrate how comparing patients from a single-arm trial can help enhance understanding of treatment effects in advance of randomized trials, inform drug development and trial design, and increase the scientific value of early phase trials.
The Phase Ib OVATION I Study evaluated escalating doses of GEN-1 administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NACT) prior to interval debulking surgery, followed by three cycles of NACT in the treatment of newly diagnosed patients with Stage III/IV 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.
CLSN shares plummeted $1.32, or 21.2%, to $4.90.
