Celsion Enrolling Patients to Complete Phase 1 OVATION Clinical Trial

Celsion Enrolling Patients to Complete Phase 1 OVATION Clinical Trial
The independent Data Safety Monitoring Board has completed its safety review of data from the first four groups of the ongoing Phase 1 OVATION Study. As a result, Celsion Corporation can continue the study as planned and complete dosing the final group of patients. “The OVATION Study continues to progress on schedule and we look forward to reporting additional clinical findings from the fourth patient cohort, as well as translational data, later this month.  Furthermore, we expect to report final data from this study in the first quarter of 2017,” Michael H. Tardugno, Celsion's chairman, CEO and president, said in a press release. The Phase 1 OVATION Study is an open-label, dose-escalating clinical trial designed to assess the safety and usefulness of combining the DNA-based immunotherapy GEN-1 (injected into the peritoneum) with neoadjuvant standard-of-care chemotherapy, in patients with newly-diagnosed, advanced ovarian cancer, who will undergo interval debulking surgery. The study includes four dose groups, designed to include three to six patients per group, to identify a maximum-tolerated dose. Celsion's GEN-1 is a lipid vesicle, designed to target specifically tumor cells, which contains a DNA molecule with the IL-12 gene. IL-12 is an immune-stimulatory molecule that activates the immune system. By delivering IL-12 directly into the tumor site, GEN-1 reduces the serious toxicities caused by an exacerbated activity of the immune system in other regions of the body. Recent results from the first three
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