LAWRENCEVILLE, NJ, January 18, 2017 – Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, today announced that the United States Patent and Trademark Office has granted U.S Utility Patent No. 9,492,385 B2 - Temperature-Sensitive Liposomal Formulation, which is directly applicable to the method of treating cancer using the Company's current ThermoDox® formulation. The claims cover intravenous or direct (to the tumor) administration of the formulation followed by heating and extends coverage time over ThermoDox's current parent patents. The Company also announced the issuance of Korean Patent No. 1652126 - Novel Thermosensitive Liposomes Containing Therapeutic Agents, which relates to composition claims directed to a thermally sensitive liposome that contains all of the components in the Company's ThermoDox® liposome as well as one additional lipid (DSPG).

These two new patents strengthen the global coverage of ThermoDox®, Celsion's proprietary dose form of doxorubicin based on a heat-activated liposomal platform technology, currently in Phase III development for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC). The Company's Phase III OPTIMA Study is expected to enroll up to 550 patients at up to 75 clinical sites in the North America, Europe, China, S. Korea, Taiwan, and Southeast Asia, and will evaluate ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating HCC lesions three to seven centimeters, versus standardized RFA alone.

"The issuance of these patents further strengthens Celsion's growing position as a leader in the development of directed chemotherapeutics designed to address some of the most difficult-to-treat cancers. In conjunction with its composition of matter patents, these new issuances broaden our intellectual property portfolio and provides for life cycle management of ThermoDox® well into the next decade. Additionally by covering the use of ThermoDox®, Celsion reinforces its exclusivity in many of the major markets around the world where HCC approaches epidemic proportions," said Michael H. Tardugno, chairman, president and CEO. "HCC has the fastest rate of growth of all cancers with annual incidence of over 800,000 new cases and is projected to be the most prevalent form of cancer by 2020."
ThermoDox® is currently in late stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and non-muscle invading bladder cancers.

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