LAWRENCEVILLE, N.J.,
April 29, 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 an
update on its clinical development plans for GEN-1, the Company's
DNA-based immunotherapy for the localized treatment of cancer, in
ovarian cancer. 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 announced plans today to expand its
ovarian cancer development program to include a Phase 1 dose
escalating trial evaluating GEN-1 in combination with Avastin® and
Doxil® in platinum-resistant ovarian cancer patients, expected to
begin in the second half of 2015. As previously reported, Celsion
intends to commence a Phase 1b dose escalating trial in newly
diagnosed ovarian cancer patients in the third quarter of this
year.
"We have demonstrated in our preclinical models that adding
GEN-1 to Avastin® can result in a powerful immunotherapy
combination for cancer patients. The mechanisms of GEN-1 and
Avastin® complement each other and may prove to be an effective
therapy in choking off cancer growth in this aggressive cancer,"
stated Nicholas Borys, M.D., Senior
Vice President and Chief Medical Officer of Celsion. "GEN-1 has
already demonstrated activity in platinum-resistant cancer patients
when combined with Doxil® and recurrent ovarian cancer patients,
two patient populations which historically have had limited
responses to new treatment options. These data, together with the
remarkable synergies observed when combining GEN-1 with Avastin® in
two recent animal studies, provide a strong rationale for continued
development in platinum-resistant patients and reflects evolving
clinical practice following the approval of Avastin® in this
indication."
The 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
ovarian cancer patients. Specifically:
- In two preclinical studies using an animal model of
disseminated ovarian cancer, GEN-1 in combination with Avastin® led
to a significant reduction in tumor burden and disease
progression. The effectiveness of the combined treatment was
seen when GEN-1 was combined with various dose levels of Avastin®
(low-medium-high). Additionally, it was demonstrated that
GEN-1 treatment alone resulted in anti-tumor activity that was as
good as or better than Avastin® treatment alone.
- The preclinical studies indicated that no obvious overt
toxicities were associated with the combined treatments. The
preclinical data are also consistent with the mechanism of action
for GEN-1, which exhibits certain anti-angiogenic properties and
suggests that combining GEN-1 with lower doses of Avastin® may
enhance efficacy and help reduce the known toxicities associated
with this anti-VEGF drug.
- The distinct biological activities of GEN-1 (immune
stimulation) and Avastin® (inhibition of tumor blood vessel
formation) makes a sound scientific rationale for this combination
approach. Additionally, the anti-angiogenic activity of GEN-1
mediated through up regulation of the interferon gamma (IFN-g)
pathway may help to explain the remarkable synergy between GEN-1
and Avastin® and potentially addresses the VEGF escape mechanisms
associated with resistance to Avastin® therapy.
- In a 16-patient Phase 1b study of GEN-1 in combination study in
platinum-resistant ovarian cancer, there were no overlapping
toxicities between GEN-1 and pegylated doxorubicin (Doxil®).
Biological activity and clinical efficacy results, including
disease control rates, translational data and survival rates, have
been submitted for presentation at the American Society of
Clinical Oncologist (ASCO) Annual Meeting.
Celsion intends to conduct additional preclinical studies to
support an Investigational New Drug filing with the U.S. Food and
Drug Administration for the planned Phase 1 combination
study. The study will be designed to optimize the dosing
regimen for GEN-1 in combination with Avastin® and is expected to
enroll approximately 12 to 18 patients.
"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,"
said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer. "In addition to
evaluating GEN-1 in first-line ovarian cancer, with Avastin's
recent approval for platinum resistant patients, we now have an
opportunity to study how it may work synergistically with Avastin®,
one of the most widely used cancer treatments with 2014 revenues of
$7.4 billion, to improve efficacy
while enhancing tolerability. The results of this important
trial may therefore highlight additional therapeutic opportunities
for GEN-1 and help guide how our development program evolves over
the long term. We look forward to launching our study in first line
ovarian cancer this year, followed by the launch of this
combination trial, and then moving into clinical studies in a
second tumor type, glioblastoma multiforme where Avastin® is
currently used."
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.
The pipeline also includes EGEN-001, a DNA-based immunotherapy for
the localized treatment of ovarian and brain cancers. Celsion
has three platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies, including TheraPlas™, TheraSilence™ and RAST ™.
For more information on Celsion, visit our website:
http://www.celsion.com.
Avastin® (bevacizumab) is the registered trademark of
Genentech. Genentech is not a collaborator with Celsion
Corporation.
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; HEAT Study data
is subject to further verification and review by the HEAT Study
Data Management Committee; the need for Celsion to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses or the possible failure to
make such acquisitions or licenses; 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/celsion-expands-clinical-development-plan-for-gen-1-il-12-immunotherapy-program-in-ovarian-cancer-300073927.html
SOURCE Celsion Corporation