Celsion Corporation
Oct 3, 2017

Celsion Announces Final Clinical and Translational Research Data from its OVATION Study at the AACR Special Conference on Ovarian Cancer

100% Disease Control; 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated in Four Dose-Escalating Cohorts

Clear Evidence of Biological Activity Including Dose Dependent Increases in Inflammatory Cytokines (IL-12 and IFN-g), Decreases in VEGF Levels and No Dose Limiting Toxicities

Expert Advisory Board Endorses Randomized Phase II in Newly Diagnosed Stage III and IV Ovarian Cancer

LAWRENCEVILLE, N.J., Oct. 03, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, today announced 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 updated the translational data from the OVATION Study in a poster presentation at the American Association of Cancer Research (AACR) Special Conference entitled "Addressing Critical Questions in Ovarian Cancer Research and Treatment" at the Wyndham Grand Pittsburgh Downtown in Pittsburgh, PA.  The poster entitled "Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer patients," was presented by Dr. Khursheed Anwer, Celsion's executive vice president and chief scientific officer in a poster session on Monday, October 2, 2017 from 6:00 PM to 8:30 PM

The Company also held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical, translational research and safety data from the OVATION Study in order to determine the next steps forward for this exciting new immunotherapy.  With the endorsement and recommendations from the Advisory Board, the Company expects to file a next phase protocol with FDA later this year.

Translational Research Data

Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized below:

These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates a shift in the primary tumor and in the surrounding tumor environment in the peritoneal cavity that promotes a pro-immune T-cell population dynamic and conversion of tumor naïve T-cell into cytotoxic effector T-cells in the tumor microenvironment.

"These distinct immunological changes in the local disease environment are likely to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line ovarian cancer," said Dr. Kunle Odunsi, Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park Cancer Institute. "Furthermore, pro-immune changes in the tumor microenvironment appear to support research combining GEN-1 with other exciting immuno-oncology therapies including adaptive T-cell and check point inhibitors."

Clinical Data

Celsion also reported highly encouraging clinical data from the first fourteen patients who have 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:

"We have completed enrollment of our Phase Ib OVATION Study in newly diagnosed ovarian cancer patients to determine GEN-1's clinical and biological activity in combination with standard chemotherapy.  The remarkable surgical outcomes for all patients completing the prescribed eight weekly treatments of GEN-1 reinforce our belief in the promise of GEN-1's ability to work safely and effectively in advanced ovarian cancer," said Dr. Nicholas Borys, Celsion's senior vice president and chief medical officer. "The Advisory Board Meetings held in late September 2017 with our clinical investigators and scientific experts in immuno-oncology provided an important endorsement of our development program for this innovative immunotherapy for first line ovarian cancer."

The poster presentation will be available on Celsion's website under "News & Investors - Scientific Presentations."

OVATION Study Design

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive 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, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.

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 recently completed 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.  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 Celsion's periodic reports and prospectuses filed with the Securities and Exchange CommissionCelsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Celsion Investor Contact

Jeffrey W. Church
Sr. Vice President and CFO

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