LAWRENCEVILLE, N.J.,
April 19, 2016 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced that preclinical data for
GEN-1 in combination with Avastin® and Doxil® was presented at the
American Association for Cancer Research (AACR) Annual Meeting 2016
in New Orleans. GEN-1 is an IL-12 DNA plasmid vector
formulated into a nanoparticle with a non-viral delivery system to
cause the sustained local production and secretion of the
Interleukin-12 (IL-12) protein loco-regionally to the tumor
site. The full poster presentation can be found
on Celsion's website at www.celsion.com.
The poster, entitled "Interleukin-12 Gene Therapy in Combination
with Bevacizumab and PEGylated Liposomal Doxorubicin for Treatment
of Disseminated Ovarian Cancer", highlighted results from a
preclinical study evaluating GEN-1 combined with Avastin® and
Doxil® in a SKOV3 human cell line implanted into immunocompromised
(nude) mice compared to control. The results showed that the
combination resulted in a statistically significant reduction of
tumor burden of greater than 98% compared to control, and a
statistically significant 92% reduction in tumor burden compared to
Avastin® plus Doxil® alone. In contrast, Avastin® and GEN-1
produced a 39% and 50% reduction in tumor burden,
respectively. The combination of GEN-1 with Avastin® and
Doxil® was well-tolerated with no systemic toxicities.
These preclinical data are consistent with the mechanism of
action for GEN-1, which exhibits certain anti-angiogenic properties
in addition to its well-characterized immunomodulatory
activities.
"These remarkable preclinical results underscore the synergistic
activity of GEN-1 and Avastin® plus Doxil®, with dramatic
reductions in tumor volume compared to either therapy alone.
The data from this trial, together with the scientific rationale
for our approach, reinforce our confidence in the potential of this
combination to improve outcomes for patients with
platinum-resistant ovarian cancer," said Khursheed Anwer, PhD,
executive vice president and chief science officer
of Celsion.
The poster also reviews clinical data from a dose-escalation
study evaluating GEN-1 plus Doxil® in platinum resistant ovarian
cancer (the GOG study). In the GOG study, at the highest dose
level, GEN-1 plus Doxil® produced an objective response rate (ORR)
of 29%. This compares favorably to the data from the Phase 3
AURELIA trial in platinum-resistant ovarian cancer, which
demonstrated that Avastin® plus chemotherapy produced an ORR of
27%. Historical data for trials evaluating Doxil® monotherapy
in platinum resistant ovarian cancer suggest ORR of only 8% to
12%.
"Our product development strategy for GEN-1 has been reinforced
by the recent FDA approval of Avastin® as a treatment for
platinum-resistant ovarian cancer coupled with our recent clinical
results using GEN-1 plus Doxil® and three strongly supportive
preclinical studies that have consistently shown improved outcomes
when GEN-1 is combined with standard of care chemotherapy and
Avastin®," said Michael H. Tardugno,
Celsion's chairman, president and CEO. "We are now completely
focused on evaluating this combination in the clinical setting, and
look forward to initiating a Phase I/II trial with the goal of
evaluating how the synergistic anti-cancer effects of GEN-1
together with Avastin® and Doxil® may improve response rates in
platinum-resistant ovarian cancer."
The Company is currently enrolling patients in the OVATION
Study, a Phase 1b dose escalating trial combining GEN-1 with
neo-adjuvant therapies in newly diagnosed ovarian cancer patients,
which will provide a starting dose for the follow-on Phase I/II
study combining GEN-1 with Avastin® and Doxil®. The Phase I/II
combination trial is expected to begin in fourth quarter of
2016.
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 activation and 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.
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-G1) (CLSN-OV)
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