Celsion Corporation Announces Issuance of Two New U.S. Patents for its GEN-1 Immuno-Oncology Product

LAWRENCEVILLE, N.J., Nov. 04, 2016 -- Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, today announced that the United States Patent and Trademark Office (USPTO) has granted two patents: Patent No. 9,468,687 B2 – Immuno Gene Therapy for Treatment of Cancer and Hyperproliferative Diseases, which expands the use of GEN-1 into additional cancer treatment modalities in combination with other chemotherapeutics and Patent No. 9,144,546 – Nucleic Acid-Lipopolymer Compositions, which expands and extends previous patent claims on the making of and composition of formulations consisting of our PPC delivery polymer and nucleic acids.

These new patents further strengthen coverage of GEN-1, the Company’s DNA-based immunotherapy in development for the localized treatment of ovarian cancer and glioblastoma multiforme (GBM), which is already covered by a composition of matter patent in the United States.

“Issuance of these patents further strengthens Celsion’s growing position as a leader in the development of gene-based immunotherapies addressing some of the most difficult-to-treat cancers, such as ovarian cancer and GBM by covering the use of GEN-1 for treating solid tumors as a monotherapy and in combination with chemotherapy,” said Michael H. Tardugno, chairman, president and CEO.  “GEN-1 leverages our proprietary TheraPlas™ technology platform, harnessing the power of IL-12 immunotherapy with a targeted delivery system engineered to overcome the limitations associated with the development of other dosage forms of IL-12 therapies.”

About GEN-1

GEN-1 is being evaluated in an ongoing Phase 1b dose-escalating clinical trial (the “OVATION Study”) combining GEN-1 with the standard of care for the treatment of newly diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debunking surgery.  The OVATION Study is designed to enroll three to six patients per dose cohort at escalating doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an antitumor immune response. 

As previously reported, all six patients in the first two cohorts of the OVATION Study experienced a clinically meaningful response, ranging from stable disease to one pathologically confirmed complete response.  In addition, all patients sustained decreases of 90% or greater of the prospective indicator of the presence of ovarian cancer cells, CA-125 protein as well as highly impressive pathologically responses, which is associated with prolonged survival. The first three cohorts each enrolled three patients.  Enrollment in the fourth and final cohort is underway, and Celsion expects to report full data from the OVATION Study by the first quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil® for the treatment of recurrent 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, including TheraPlas™ and TheraSilence™.  For more information on Celsion, visit our website: http://www.celsion.com (CLSN-FIN).

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.

Celsion Investor Contact

Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
[email protected]