| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
110 Patients Enrolled in Study Comparing Novel Gene-Mediated Immunotherapy plus Neoadjuvant Chemotherapy versus Neoadjuvant Chemotherapy Alone
LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. GEN-1 is the Company's IL-12 gene-mediated immunotherapy. Topline results are expected in the second half of 2023.
The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. The study is designed with an 80% confidence interval to show an approximate 33% improvement in progression-free survival when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only).
IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.
"We are delighted to reach this important milestone of completing enrollment in our Phase I/II OVATION 2 Study with GEN-1 and are optimistic the study will show our technology's ability to deliver the powerful immune-modulating agent IL-12," said Corinne Le Goff, Ph.D., president and chief executive officer of Celsion Corporation. "Preliminary interim data in this study are very promising, showing both safety and activity. We look forward to completing the study and reporting top line results, in the second half of 2023."
The Company announced in June 2022 that following a pre-planned interim safety review of 87 patients (46 in the experimental arm and 41 in the control arm), the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit. No dose-limiting toxicities were reported.
In June, the Company also announced that interim clinical data from 70 patients who underwent interval debulking surgery showed that those in the GEN-1 treatment arm had improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores versus the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.
In February 2021, the FDA awarded fast track designation to GEN-1 in advanced ovarian cancer. Celsion plans to request FDA breakthrough therapy designation for GEN-1 based on the encouraging clinical data.
About GEN-1 Immunotherapy
Designed using Celsion's proprietary TheraPlas platform technology, GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The Company previously reported positive safety and encouraging Phase I results with GEN-1 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase Ib dose-escalation trial (the OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.
Posted In: CLSN
