Celsion Corporation Announces Issuance of Two New U.S. Patents for its GEN-1 Immuno-Oncology Product
November 04 2016 - 8:00AM
Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug
development company, today announced that the United States Patent
and Trademark Office (USPTO) has granted two patents: Patent No.
9,468,687 B2 – Immuno Gene Therapy for Treatment of Cancer and
Hyperproliferative Diseases, which expands the use of GEN-1 into
additional cancer treatment modalities in combination with other
chemotherapeutics and Patent No. 9,144,546 – Nucleic
Acid-Lipopolymer Compositions, which expands and extends previous
patent claims on the making of and composition of formulations
consisting of our PPC delivery polymer and nucleic acids.
These new patents further strengthen coverage of
GEN-1, the Company’s DNA-based immunotherapy in development for the
localized treatment of ovarian cancer and glioblastoma multiforme
(GBM), which is already covered by a composition of matter patent
in the United States.
“Issuance of these patents further strengthens
Celsion’s growing position as a leader in the development of
gene-based immunotherapies addressing some of the most
difficult-to-treat cancers, such as ovarian cancer and GBM by
covering the use of GEN-1 for treating solid tumors as a
monotherapy and in combination with chemotherapy,” said Michael H.
Tardugno, chairman, president and CEO. “GEN-1 leverages our
proprietary TheraPlas™ technology platform, harnessing the power of
IL-12 immunotherapy with a targeted delivery system engineered to
overcome the limitations associated with the development of other
dosage forms of IL-12 therapies.”
About GEN-1
GEN-1 is being evaluated in an ongoing Phase 1b
dose-escalating clinical trial (the “OVATION Study”) combining
GEN-1 with the standard of care for the treatment of newly
diagnosed patients with advanced ovarian cancer who will undergo
neoadjuvant chemotherapy followed by interval debunking
surgery. The OVATION Study is designed to enroll three to six
patients per dose cohort at escalating doses of GEN-1 with the goal
to identify a safe, tolerable and therapeutically active dose of
GEN-1 by recruiting and maximizing an antitumor immune
response.
As previously reported, all six patients in the
first two cohorts of the OVATION Study experienced a clinically
meaningful response, ranging from stable disease to one
pathologically confirmed complete response. In addition, all
patients sustained decreases of 90% or greater of the prospective
indicator of the presence of ovarian cancer cells, CA-125 protein
as well as highly impressive pathologically responses, which is
associated with prolonged survival. The first three cohorts each
enrolled three patients. Enrollment in the fourth and final
cohort is underway, and Celsion expects to report full data from
the OVATION Study by the first quarter of 2017. Future studies of
GEN-1 will include a Phase I/II study combining GEN-1 with Avastin®
and Doxil® for the treatment of recurrent ovarian cancer.
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
(CLSN-FIN).
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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