On March 1, 2016 Celsion Corporation (NASDAQ: CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies for the treatment of cancer and other difficult-to-treat diseases, reported that the U.S. Patent and Trademark Office (USPTO) issued a key patent (U.S. Patent No. 9,254,334 B2) which provides broad intellectual property protection covering the therapeutic use of the Company’s proprietary TheraSilence lung-specific delivery system in a broad range of therapeutic entities, including the delivery of synthetically-generated inhibitory RNA (RNAi) such as small inhibitory RNAs (siRNAs), microRNAs, microRNA mimics, anti-microRNAs and related molecules that can regulate protein expression at the transcript level by exploiting endogenous cell mechanisms (Press release, Celsion, MAR 1, 2016, View Source [SID:1234509317]).

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This new patent further strengthens previously issued patents directed at the composition of the Company’s proprietary TheraSilence family of delivery systems.

"This newly granted patent enhances our strong IP protection surrounding the novel composition of matter claims for our TheraSilence lung-specific delivery system and expands our use claims covering a broad range of therapeutic RNA entities to provide unique treatment options for lung diseases that are not addressable by conventional drugs," said Michael H. Tardugno, chairman, president and chief executive officer of Celsion Corporation. "Our strategy is to seek to maximize the value of this platform in the near-term by pursuing collaborations and development agreements, while focusing internal development efforts on our two clinical stage candidates, ThermoDox and GEN-1, our DNA-based immunotherapy for the localized treatment of ovarian cancer."

Celsion previously announced compelling preclinical findings confirming that the Company’s TheraSilence technology platform can safely and effectively deliver RNA to the lungs in non-human primates. In the study, TheraSilence-formulated signaling RNA resulted in preferential expression in the lungs, with expression in the liver at less than 15% of expression levels observed in the lungs. Expression levels in tissues other than the lung, spleen and liver were very low or at background levels. These data build on previous preclinical studies indicating the preferential delivery of RNA to the lung using the TheraSilence RNA delivery system.

A murine study demonstrated that the delivery of TheraSilence-formulated siRNA molecules designed to target vascular endothelial receptor 2 (VEGFR2), a protein that is critical for the growth of new blood vessels in tumors, significantly inhibited VEGFR2 expression and lung tumor growth.
Delivery of a TheraSilence-formulated anti-micro RNA molecule into rats with experimentally induced pulmonary arterial hypertension appeared to normalize vascular remodeling that occurs in the lung and help restore cardiac function that is compromised as a result of the disease.