Celsion Corporation Announces Clinical Progress for Two of its Development Programs
January 18, 2018 at 06:30 pm IST
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Celsion Corporation provided a year-end 2017 corporate review and announced clinical progress for two of its development programs: ThermoDox®, a proprietary, heat-activated liposomal encapsulation of doxorubicin, which is in Phase III development for treatment of primary liver cancer; and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein, and which is in Phase I development for the localized treatment of ovarian cancer. Clinical Developments; The final overall survival (OS) analysis from the HEAT study demonstrated that in a large, well-bounded subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox® and standardized RFA provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) was 0.63 (95% CI 0.43 - 0.93) with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox® plus standardized RFA group translated into a 25.4-month (more than 2.1 years) survival benefit over the standardized RFA-only group, totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox® plus standardized RFA group, versus 53 months for the standardized RFA-only group. OVATION Study Update. In October 2017, the Company announced completion of enrollment and final clinical and translational research data from its OVATION Study, a Phase Ib 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 Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site. The company further reported encouraging clinical data from the first fourteen patients who completed treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced positive clinical results, with no dose-limiting toxicities and promising dose-dependent efficacy signals, which correlate well with successful surgical outcomes as summarized below: Of the fourteen patients treated in the entire study, two patients demonstrated a complete response, ten patients demonstrated a partial response and two patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate ("DCR") and an 86% objective response rate ("ORR"). Of the five patients treated in the highest dose cohort, there was a 100% objective response rate with one complete response and four partial responses. Fourteen patients had resections of their tumors, with nine patients (64%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical resection. All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.
Imunon, Inc. is a clinical-stage biotechnology company. The Company is focused on advancing a portfolio of treatments that harness the bodyâs natural mechanisms across an array of human diseases. The Company is developing non-viral Deoxyribonucleic acid (DNA) technology across four modalities. The first modality, TheraPlas, is developed for the coding of proteins and cytokines in the treatment of solid tumors. The second modality, PlaCCine, is developed for the coding of viral antigens that can elicit a strong immunological response. The third modality, FixPlas, concerns the application of Imunonâs DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas, is in the discovery phase and is focused on the development of personalized cancer vaccines, or neoepitope cancer vaccines. Its lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer.