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 cohorts of OVATION have shown a 100% disease control rate and a 66% objective response rate, with all nine patients showing at least stable disease following therapy (one complete response, five partial responses, and three stable disease).
“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, MD, 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),” he continued. “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.”
Celsion in now completing the enrollment of patients into OVATION’s fourth trial group.