Data to be Highlighted During Oral Session on March 2, 2019
LAWRENCEVILLE, N.J., Jan. 15, 2019 (GLOBE NEWSWIRE) -- Celsion Corporation (CLSN), an oncology drug development company, today announced that data from a Phase I study of GEN-1, its DNA-based immunotherapy for the localized treatment of ovarian cancer as an adjuvant to chemotherapy current standard of care, has been selected for oral presentation at the upcoming ASCO-SITC Clinical Immuno-Oncology Symposium held in San Francisco on Feb. 28 through March 2, 2019. The abstract titled, “Phase I study of the safety and activity of formulated IL-12 plasmid administered intraperitoneally in combination with neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer,” was featured as a “Highlights” Abstract by ASCO-SITC and will be presented by Premal H. Thaker, M.D., M.S., 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.
The abstract (Abstract 2) will be presented as part of Oral Abstract Session C held on Saturday, March 2, 2019 from 10:15 – 11:30 a.m. PST (1:15 – 2:30 p.m. EST) at the San Francisco Marriott Marquis.
GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a synthetic, non-viral, 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 recurrent advanced ovarian cancer. The Phase IB OVATION I Study, which evaluated escalating doses of GEN-1 in combination with three cycles of neoadjuvant chemotherapy prior to interval surgery followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer, demonstrated median progression-free survival (PFS) of 24.3 months in patients treated per protocol (n=13) and 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full neoadjuvant chemotherapy (NAC) and GEN-1 cycles.
The OVATION 2 Phase I/II study in patients newly diagnosed with Stage III/IV ovarian cancer, was initiated in September 2018 and is designed with a single dose-escalation phase to 100 mg/m² of GEN-1 administered intraperitoneally in the Phase I portion, followed by a continuation at the selected dose in Phase II, in an open-label, 1:1 randomized design. The OVATION 2 Study will evaluate the effect of initial and maintenance dosing of GEN-1 on PFS in up to 130 patients.
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.
ThermoDox® is a registered trademark of Celsion Corporation.