LAWRENCEVILLE, N.J.,
March 1, 2016 /PRNewswire/
-- 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, today announced
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. 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.
About TheraSilence™
TheraSilence™ is a technology platform for the delivery of
synthetically-generated messenger RNA, 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. Inhibitory RNA based therapies have potential for
targeting virtually any disease related gene with a high degree of
specificity and thus eliminating so called "non-drugable" target
classes. The technology addresses the primary obstacle to nucleic
acid-based therapeutics, which is the safe and efficient delivery
to target cells. These systems are chemically flexible and
amenable to attachment of tissue-targeted ligands, in vivo
stabilizing agents and other functional moieties which can tailor a
formulation for a particular application and delivery modality.
These features can provide high specificity for RNAi delivery to
select tissue, enhance stability and reduce in vivo toxicity.
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.
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
jchurch@celsion.com
Celsion Media Contacts
Harriet Shelare
Director, Communications
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation