LAWRENCEVILLE, N.J., March 05, 2018 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN) today announced that Premal H. Thaker, M.D., M.S., Associate Professor of Obstetrics and Gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis, Mo. and investigator in Celsion’s GEN-1 development program presented, “Ovarian Cancer: New Horizons and Treatments” at an investor event hosted by Oppenheimer & Co. in New York City on March 1, 2018. A nationally recognized expert in gynecologic oncology, Dr. Thaker provided an overview of the symptoms and diagnosis of ovarian cancer, current standard of care and novel new therapies, including Celsion’s GEN-1 DNA-based, IL-12 immunotherapy currently in Phase I development for the treatment of ovarian cancer.
“Ovarian cancer is the fourth deadliest cancer among women in developed countries and often goes undetected in its earlier stages, with more than 60% of patients first diagnosed at Stage III/IV,” said Dr. Thaker. “Adequate surgery is vital in treating ovarian cancer, with a complete resection (R0) being the primary objective. Neoadjuvant chemotherapy is currently used to reduce tumor burden and improve surgical outcomes, but new treatment approaches in development, including anti-angiogeneic inhibitors, PARP inhibitors and immunotherapies represent compelling new areas of innovation that have the potential to meaningfully improve outcomes. In this environment we have been evaluating GEN-1’s potential to improve patient outcomes.”
“Ovarian cancer is characterized by a strong immunosuppressive environment, and a spontaneous anti-tumor reactive T-cells and antibodies,” Dr. Thaker continued. “Celsion’s GEN-1 is a novel new approach that is designed to deploy the anti-cancer mechanism of the potent, broad spectrum immunotherapy, IL-12, without the toxicities associated with the recombinant IL-12 protein. In a Phase I study of GEN-1, 14 newly diagnosed patients with Stage III/IV ovarian cancer were intraperitoneally administered GEN-1 plus neoadjuvant chemotherapy. Results from the study demonstrated immunological changes consistent with the ability of GEN-1 to increase local (peritoneal) levels of IL-12 and its downstream anti-cancer cytokines and reduction in vascular endothelial growth factor (VEGF; potent angiogenic factor that contributes to tumor angiogenesis) levels with little changes in systemic circulation. Furthermore, the study showed no serious systemic toxicities. These clinical findings, including a partial or complete response in 86% of patients, R0 resections in 100% of patients treated at the highest dose cohort and recently reported progression-free survival (PFS) of 21 months compared to historical controls for PFS of approximately 12 months, support further evaluation of GEN-1’s safety and efficacy in patients with Stage III/IV ovarian cancer.”
Celsion expects to initiate enrollment in the Phase I portion of the OVATION II Study of GEN-1 during the first half of 2018 in up to 90 patients with Stage III/IV ovarian cancer at up to fifteen U.S. centers. The Phase I/II study will be powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with neoadjuvant chemotherapy to neoadjuvant chemotherapy alone.
Slide Presentation Available on Celsion’s Website
To view Dr. Thaker’s full slide presentation from the event, please visit Celsion’s corporate website at http://investor.celsion.com/scientific-presentations .
About GEN-1 Immunotherapy
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.
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company’s lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-G1 CLSN-OV)
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion’s periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
CONTACT: Celsion Investor Contact Jeffrey W. Church Sr. Vice President and CFO 609-482-2455 firstname.lastname@example.org