Celsion Corporation Announces FDA Clearance of the OVATION II Study for the Evaluation of Gen-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer
January 04, 2018 at 08:00 am EST
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Celsion Corporation announced that the U.S. Food and Drug Administration (FDA), following the customary 30 day review period, has accepted its submission without comment, providing clearance for the OVATION II Study, the company’s planned Phase I/II clinical trial of GEN-1, its DNA-based immunotherapy for the localized treatment of ovarian cancer. The Phase I/II trial was developed with extensive input from the Company’s Medical Advisory Board. The OVATION II Study builds on the highly promising clinical and translational research data from the Phase IB dose-escalating OVATION Study where enrolled patients received escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, in combination with neoadjuvant chemotherapy, followed by interval debulking surgery. This next Phase I/II study is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune response, followed by a continuation at the selected dose in Phase II in an open label, 1:1 randomized design up to 90 patients with Stage III/IV ovarian cancer at up to fifteen U.S. centers. The study is powered to show a 33% improvement in the primary endpoint, progression-free survival (PFS), when comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone. Progression-free survival for patients treated per protocol in the Phase IB OVATION Study continues to be followed. Of the thirteen patients who received GEN-1 treatment in all four dose escalating cohorts, only four patients’ cancer has progressed to-date. This compares favorably to the historical median progression-free survival of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Summarized below are the latest PFS results for all patients treated per protocol in the Phase IB OVATION Study: Cohort 1 (36 mg/m²) All patients have progressed; Average PFS was 19.25 months; Longest progression-free patient in 1st cohort was 24.8 months. Cohort 2 (47 mg/m²) No patients have progressed after 21 months. Cohort 3 (61 mg/m²) One patient has progressed after 14 months; Two other patients in 3rd cohort are progression free over 17 months. Cohort 4 (79 mg/m²) No patients have progressed; Average PFS for these five patients in 4th cohort is 14 months. GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is 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. 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 (NK) cell proliferation. The company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.
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.
Celsion Corporation Announces FDA Clearance of the OVATION II Study for the Evaluation of Gen-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer