LAWRENCEVILLE, N.J., May 22, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) announced today that its proprietary patent application, "Method of Storing Nanoparticle Formulations," has now been granted in the four largest markets for liver cancer globally: China, Japan, South Korea and most recently Taiwan. Celsion holds an exclusive license agreement with Duke University for its temperature sensitive liposome technology which covers the ThermoDox® formulation. Celsion's newly issued patents pertain specifically to methods of storing stabilized, temperature-sensitive liposomal formulations and will assist in the protection of global rights by extending the overall term of the ThermoDox® patent portfolio to August 2026. The patents in these four countries, in addition to the previously granted patent for Australia, are the first five territories in this family which includes pending applications in the US, Europe and additional
key commercial geographies.
Complementing ThermoDox's extended patent protection, Celsion is working with its partners to pursue the data needed to secure marketing approval in the China market. This may involve further prospective studies to confirm that optimization of radiofrequency ablation (RFA) is required for maximal ThermoDox® benefit. An extended patent runway to 2026 allows for the evaluation of future development activities for ThermoDox and Celsion's heat-sensitive liposome technology which are supported by the emerging post-hoc findings from the HEAT Study.
While the Phase III HEAT Study failed to meet its primary end point, progression free survival, Celsion has continued efforts to perform population subgroup analyses, and remains committed to evaluating ThermoDox® for the high-incidence liver cancer regions. The Company notes recent presentations at the 2013 World Conference on Interventional Oncology (WCIO) on May 16, 2013 which identified large, but not statistically significant, subgroups that appear to have clinical benefit when ThermoDox is combined with an optimized RFA procedure.
"Our program for expanding patent coverage adds long-term value to our drug pipeline. Extending the term of our ThermoDox® patent estate supports our multifaceted portfolio development and life-cycle management strategy for our unique temperature-sensitive liposomal formulations," said Michael H. Tardugno, Celsion's President and Chief Executive Officer.
About Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital,
the Beijing Cancer Hospital and the University of Oxford. For more information on Celsion, visit our website: http://www.celsion.com.
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 significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; termination of the Technology Development Contract or collaboration between Celsion and HISUN at any time; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; 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.
Jeffrey W. Church
Sr. Vice President — Corporate
Strategy and Investor Relations
SOURCE Celsion Corporation