Celsion Corporation
Oct 29, 2014

Celsion Presents Preclinical Data for its TheraSilence™ Platform at the miRNA World Conference Workshop on miRNA Delivery

Data Supportive of GEN-2, an RNAi Carrier for Therapeutic Treatment of Lung Cancer

LAWRENCEVILLE, N.J., Oct. 29, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced the presentation of data related to TheraSilence™, the Company's lung-specific RNA delivery technology, at the miRNA World Conference Workshop on miRNA Delivery in Boston, MA.  The data was presented by Dr. Khursheed Anwer, Celsion's Executive Vice President and Chief Scientific Officer, during a panel presentation, and highlighted formulation characteristics of the TheraSilence delivery platform, preclinical proof-of concept data and data supportive of GEN-2 (formerly referred to as EGEN-002), Celsion's RNA interference (RNAi) therapeutic for the treatment of lung cancer. Celsion acquired the TheraSilence platform and GEN-2 through its acquisition of EGEN, Inc. in June 2014.

"Our TheraSilence delivery platform is designed to overcome the challenges associated with delivery of RNA for the treatment of lung diseases, with a chemically flexible system that allows us to improve the safety, stability, and efficiency of RNA delivery to the lung," stated Dr. Anwer. "The data presented was developed under a research collaboration and shows that intravenous administration of small RNAs formulated with our delivery system produced significant and durable RNA activity specifically in the lung following a single injection, and demonstrate how siRNAs delivered via our TheraSilence platform can specifically target VEGFR-2 to inhibit tumor growth in the lung." 

The data from the research collaboration was jointly published in Molecular Therapy (January 2012, Volume 20).  The publication can be found on the Company's website, http://celsion.com/files/polach-lung-paper.pdf  under Journal Articles and Publications

GEN-2 leverages the TheraSilence delivery system and combines two unique molecular targets involved in tumor regulation to inhibit tumor growth and promote direct killing of tumor cells. Among its capabilities as a platform for therapeutic application, GEN-2 also has demonstrated an ability to incorporate short interfering RNA (siRNA) targeting VEGFR-2, a tumor angiogenesis factor, and a microRNA that is involved in tumor inhibition. 

The highlights of the presentation are included below:

  • In a mouse lung tumor model, intravenous (IV) delivery of RNA inhibiting VEGFR-2, a tumor angiogenesis factor, with the TheraSilence delivery system resulted in significant knockdown of VEGFR-2 transcript in lungs, reduction in tumor blood vessel density and inhibition of tumor growth. 
  • Studies also demonstrated the ability of anti-miRNA delivered via the TheraSilence system to inhibit miRNA-145, which is associated with the pathogenesis of pulmonary arterial hypertension (PAH). In a rat model of severe PAH, IV administration of antimir-145 formulated with TheraSilence resulted in preferential accumulation of the anti-miRNA in lungs, reduction in miRNA-145 transcript in lungs, and reversal of cardiopulmonary parameters associated with the disease.
  • Systemically administered RNA complexes using the TheraSilence delivery system demonstrated a good tolerability profile.
  • The presentation also describes ligand modification with the TheraSilence platform to improve cell specificity of RNA delivery in vitro. 

"The results presented today highlight the potential of our TheraSilence platform to provide unique treatment options for lung diseases that are not addressable by conventional drugs," Michael H. Tardugno, Celsion's Chairman and Chief Executive Officer.  "While we remain focused on advancing our clinical stage programs, ThermoDox® and EGEN-001, we see significant value in this delivery platform and in GEN-2 in particular.  Our internal research and collaboration with the University of S. Alabama provide a robust basis to further explore GEN-2's utility and great potential for novel treatments of various lung diseases."  

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 EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers.  Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™, TheraSilence™ and RAST ™.  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 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 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 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
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