Celsion Corporation Announces Issuance of Two New Patents for ThermoDox®
January 18 2017 - 8:00AM
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.
About ThermoDox®
Celsion's most advanced program is a
heat-mediated drug delivery technology that employs a novel
heat-sensitive liposome engineered to address a range of
difficult-to-treat cancers. The first application of this platform
is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD),
whose novel mechanism of action delivers high concentrations of
doxorubicin to a region targeted with the application of localized
heat at 40°C, just above body temperature. ThermoDox® has the
potential to address a broad range of cancers.
Celsion's LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. In the first mechanism, rapidly
growing tumors have leaky vasculature, which is permeable to
liposomes and enables their accumulation within tumors. Leaky
vasculature influences a number of factors within the tumor,
including the access of therapeutic agents to tumor cells.
Administered intravenously, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the
tumor site as these liposomes recirculate in the blood stream.
In the second mechanism, when an external heating device
heats tumor tissue to a temperature of 40°C or greater, the
heat-sensitive liposome rapidly changes structure and the liposomal
membrane selectively dissolves, creating openings that can release
a chemotherapeutic agent directly into the tumor and into the
surrounding vasculature. Drug concentration increases as a function
of the accumulation of liposomes at the tumor site, but only where
the heat is present. This method damages only the tumor and the
area related to tumor invasion, supporting more precise drug
targeting.
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
(LTSL/ThermoDox®, HEAT Study/HCC, OPTIMA Study/HCC).
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
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