Celsion's (CLSN) Phase 1b OVATION Study Receives Positive IDSMB Safety Review

December 1, 2016 8:05 AM EST

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Celsion Corporation (Nasdaq: CLSN) announced that the independent Data Safety Monitoring Board (DSMB) has completed its safety review of data from the first four patient cohorts in the ongoing Phase 1b OVATION Study. Based on the DSMB’s recommendation, the study will continue as planned and the Company will proceed with completing dosing in the fourth and final patient cohort, which is currently enrolling patients. The OVATION Study is a dose-escalating clinical trial combining GEN-1, the Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.

“We are very encouraged by the data reported to date. In the first three cohorts, we saw remarkable and consistent responses across a number of clinically meaningful measures, underscoring the potential promise of our immunotherapy approach in this difficult-to-treat patient population,” said Michael H. Tardugno, Celsion's chairman, CEO and president. “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.”

“Our OVATION Study is achieving its objective of demonstrating that GEN-1 can be safely administered directly into the peritoneum and is well tolerated by patients when combined with standard neoadjuvant chemotherapy,” said Nicholas Borys, M.D., senior vice president and chief medical officer of Celsion. “As we have previously reported, all nine patients in the first three cohorts experienced a clinically meaningful response, ranging from stable disease to one pathologically confirmed complete response. Two-thirds of patients treated in the trial experienced at objective tumor response. We also observed three cases of no visible residual disease at time of surgery (R0 resection). In addition, we saw sustained decreases of 90% or greater of the prospective indicator of the presence of ovarian cancer cells, CA-125 protein, in all patients, as well as highly impressive pathologically responses, which is associated with prolonged survival. We hope to build on these impressive results with our translational data, which will provide further insights on the impact of localized IL-12 production with GEN-1.”

The OVATION Study is designed to enroll three to six patients per dose cohort at escalating doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first three cohorts each enrolled three patients. Enrollment in the fourth and final cohort is underway, and Celsion expects to report full data from the OVATION Study by the first quarter of 2017.



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