LAWRENCEVILLE, N.J.,
Sept. 9, 2015 /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, announced today
that the Company has completed the integration of its June 2014 acquisition of EGEN, Inc. and has
provided an update on its clinical development plans for GEN-1, the
Company's DNA-based immunotherapy for the localized treatment of
ovarian and brain cancer.
Following the acquisition of EGEN, Celsion has consolidated all
early stage and preclinical assets at its Huntsville, AL facility. All clinical
development, commercialization (including its Early Access Programs
for ThermoDox), business development and administrative functions
are now located in Lawrenceville,
NJ. From this reorganization, Celsion expects to realize a 15
to 20 percent reduction in personnel and related annual operational
costs.
Additionally, the Company has evaluated opportunities to
maximize efficiency in its GEN-1 IL-12-based immunotherapy and has
structured its clinical development program to capitalize on
previously established proof-of-concept clinical data. GEN-1
has demonstrated promising clinical activity and tolerability in
platinum-resistant and recurrent ovarian cancer patients, as well
as synergistic anti-cancer effects in combination with bevacizumab
(Avastin®) in preclinical models.
- The Company's OVATION Study, a Phase 1b dose escalating trial
combining GEN-1 with neo-adjuvant therapies in newly diagnosed
ovarian cancer patients, is expected to commence enrollment in the
second half of 2015. The first OVATION site at the University of Alabama at Birmingham has been
initiated, with three additional sites expected to follow shortly.
Data from this open label study is expected in the fourth quarter
of 2015, and will continue into the first half of next year at
higher doses of GEN-1. This trial will provide a starting dose for
a follow-on Phase I/II study combining GEN-1 with Avastin and
Doxil.
- The Company also expects to commence a second ovarian cancer
development program with initiation of a Phase I/II dose escalating
trial evaluating GEN-1 in combination with Avastin® and Doxil® in
platinum-resistant ovarian cancer patients later this year. This
new combination study in platinum-resistant ovarian cancer is
supported by two preclinical studies demonstrating that the
combination of GEN-1 with Avastin® may result in significant
clinical benefit with a favorable safety profile, as well as a
prior Phase 1b trial of GEN-1 plus Doxil® in platinum resistant
breast cancer patients.
- The Company is now completing a comprehensive series of
pre-clinical safety and efficacy studies, and plans to initiate a
third Phase I trial combining GEN-1 with current standard of care
to treat newly resected glioblastoma multiforme (GBM) brain cancer
patients in 2016.
"Over the past 12 months, since our acquisition of EGEN, Inc.,
we have carefully evaluated our current organizational structure
and collective management competencies to determine the most
efficient path forward for our broad, diversified product
pipeline. Our new organization will be both lean and focused
on generating clinical data from our GEN-1 platform,"
said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. "As an IL-12
immunotherapy, GEN-1 has broad potential in multiple tumor types,
and our clinical strategy is designed to accelerate its
development, establish its clinical utility in various indications
and drive it toward the market."
About GEN-1 Immunotherapy
GEN-1, designed using Celsion's proprietary TheraPlas™
platform technology, is an IL-12 DNA plasmid vector encased in a
nanoparticle delivery system, which enables cell transfection
followed by persistent, local secretion of the IL-12 protein. IL-12
is one of the most active cytokines for the induction of potent
anti-cancer immunity acting through the induction of T-lymphocyte
and natural killer (NK) cell proliferation. The Company has
previously reported positive safety and encouraging Phase I results
with GEN-1 given as monotherapy in patients with peritoneally
metastasized ovarian cancer, and recently completed a Phase Ib
trial of GEN-1 in combination with PEGylated doxorubicin in
patients with platinum-resistant ovarian cancer. GEN-1 has also
demonstrated preclinical activity in glioblastoma multiforme (brain
cancer) and the Company plans to initiate a Phase I study in this
indication in the second half of 2015.
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
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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