Celsion’s GEN-1 Combined with Chemotherapy May Help Treat Advanced Ovarian Cancer

Celsion’s GEN-1 Combined with Chemotherapy May Help Treat Advanced Ovarian Cancer
Interim results of a clinical trial evaluating Celsion’s GEN-1 combined with preoperative chemotherapy to treat patients with advanced ovarian cancer were recently presented at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting. The Phase 1b OVATION study (NCT02480374) is a dose-escalating trial that is currently evaluating the safety and effectiveness of GEN-1 (injected into the peritoneum) combined with chemotherapy in patients with newly diagnosed advanced ovarian cancer who will undergo surgery after chemo. The study includes four dose groups designed to include three to six patients per group to identify a maximum-tolerated dose. GEN-1 is a lipid vesicle containing the DNA of the IL-12 gene. IL-12 is an immune-stimulatory molecule that activates the immune system. By delivering IL-12 directly into cancer cells, GEN-1 reduces the adverse effects caused by increased inflammatory activity in other regions of the body. According to Celsion, the last patient in this trial has been dosed. Now there will be a safety evaluation by the company’s Data Safety Monitoring Board. Results showed that, of the 14 treated patients, two achieved a complete response, 10 achieved partial response, and two patients maintained stable disease. Researchers observed a disease control rate (DCR) and an objective response rate (ORR) of 100% and 86%, respectively. Also, of the five patients in the group treated with the highest dose, four achieved partial response and one was completely treated. “We have seen promising clinical findings including objective responses [complete and partial] in all patients at the highest dose cohort, along with an 87.5% rate of R0 (margin-negative) resections in the two highest dose cohorts and a 100% rate of R0 res
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